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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06780137
Registration number
NCT06780137
Ethics application status
Date submitted
13/01/2025
Date registered
17/01/2025
Date last updated
14/07/2025
Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
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Scientific title
A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
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Secondary ID [1]
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0
2024-517926-25-00
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Secondary ID [2]
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6070-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Lung - Mesothelioma
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Cancer
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0
0
0
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Lung - Non small cell
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Cancer
0
0
0
0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Gocatamig
Treatment: Other - Ifinatamab Deruxtecan (I-DXd)
Treatment: Other - Durvalumab
Experimental: Part 1 Arm 1: Gocatamig and I-DXd - Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 2: Gocatamig and I-DXd - Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 3a: I-DXd Monotherapy - Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 3b: Gocatamig and I-DXd - Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 4: Gocatamig Monotherapy in Japan - Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 5: Gocatamig Monotherapy in China - Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 6: Gocatamig - Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 3 Arm 7: Gocatamig and Durvalumab - Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Other: Gocatamig
IV infusion
Treatment: Other: Ifinatamab Deruxtecan (I-DXd)
IV infusion
Treatment: Other: Durvalumab
IV infusion
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Who Experience an Adverse Event (AE)
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Assessment method [1]
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0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.
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Timepoint [1]
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Up to approximately 44 months
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Primary outcome [2]
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Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
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Assessment method [2]
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A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented.
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Timepoint [2]
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0
Up to approximately 3 weeks
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Primary outcome [3]
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0
Number of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [3]
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0
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.
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Timepoint [3]
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0
Up to approximately 44 months
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Primary outcome [4]
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Part 1: Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
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Timepoint [4]
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0
Up to approximately 44 months
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Secondary outcome [1]
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0
Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR)
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Assessment method [1]
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For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
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Timepoint [1]
0
0
Up to approximately 44 months
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Secondary outcome [2]
0
0
Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
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Timepoint [2]
0
0
Up to approximately 44 months
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Secondary outcome [3]
0
0
Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): ORR
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Assessment method [3]
0
0
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
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Timepoint [3]
0
0
Up to approximately 44 months
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Secondary outcome [4]
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Maximum Concentration (Cmax) of gocatamig
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Assessment method [4]
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0
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig.
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Timepoint [4]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [5]
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Cmax of ifinatamab deruxtecan (I-DXd)
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Assessment method [5]
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0
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd.
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Timepoint [5]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [6]
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0
Cmax of Anti-B7-H3 Antibody
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Assessment method [6]
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0
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody.
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Timepoint [6]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [7]
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0
Cmax of Deruxtecan (DXd)
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Assessment method [7]
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0
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd).
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Timepoint [7]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [8]
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0
Cmax of Durvalumab
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Assessment method [8]
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0
Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab.
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Timepoint [8]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [9]
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Time to maximum concentration (Tmax) of gocatamig
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Assessment method [9]
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Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig.
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Timepoint [9]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [10]
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Tmax of I-DXd
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Assessment method [10]
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0
Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd.
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Timepoint [10]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [11]
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0
Tmax of Anti-B7-H3 Antibody
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Assessment method [11]
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0
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody.
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Timepoint [11]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [12]
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0
Tmax of DXd
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Assessment method [12]
0
0
Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd.
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Timepoint [12]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [13]
0
0
Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig
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Assessment method [13]
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0
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug gocatamig.
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Timepoint [13]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [14]
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0
AUCt of I-DXd
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Assessment method [14]
0
0
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug I-DXd.
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Timepoint [14]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [15]
0
0
AUCt of Anti-B7-H3 Antibody
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Assessment method [15]
0
0
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the anti-B7-H3 antibody.
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Timepoint [15]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [16]
0
0
AUCt of DXd
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Assessment method [16]
0
0
AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug payload Dxd.
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Timepoint [16]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [17]
0
0
Terminal Half-Life (t1/2) of gocatamig
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Assessment method [17]
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0
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug gocatamig.
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Timepoint [17]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [18]
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0
t1/2 of I-DXd
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Assessment method [18]
0
0
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug I-DXd.
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Timepoint [18]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [19]
0
0
t1/2 of Anti-B7-H3 Antibody
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Assessment method [19]
0
0
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the anti-B7-H3 antibody.
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Timepoint [19]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [20]
0
0
t1/2 of DXd
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Assessment method [20]
0
0
t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug payload DXd.
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Timepoint [20]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [21]
0
0
Steady State Maximum Concentration (Cmax,ss) of gocatamig
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Assessment method [21]
0
0
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig.
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Timepoint [21]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [22]
0
0
Cmax,ss of I-DXd
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Assessment method [22]
0
0
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd.
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Timepoint [22]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [23]
0
0
Cmax,ss of Anti-B7-H3 Antibody
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Assessment method [23]
0
0
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody.
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Timepoint [23]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [24]
0
0
Cmax,ss of DXd
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Assessment method [24]
0
0
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd.
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Timepoint [24]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [25]
0
0
Cmax,ss of Durvalumab
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Assessment method [25]
0
0
Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab.
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Timepoint [25]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [26]
0
0
Steady State Ctrough (Ctrough,ss) of gocatamig
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Assessment method [26]
0
0
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig.
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Timepoint [26]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [27]
0
0
Ctrough,ss of I-DXd
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Assessment method [27]
0
0
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd.
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Timepoint [27]
0
0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [28]
0
0
Ctrough,ss of Anti-B7-H3 Antibody
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Assessment method [28]
0
0
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody.
Query!
Timepoint [28]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [29]
0
0
Ctrough,ss of DXd
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Assessment method [29]
0
0
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd.
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Timepoint [29]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [30]
0
0
Ctrough,ss of Durvalumab
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Assessment method [30]
0
0
Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab.
Query!
Timepoint [30]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [31]
0
0
Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig
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Assessment method [31]
0
0
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig.
Query!
Timepoint [31]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [32]
0
0
Tmax,ss of I-DXd
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Assessment method [32]
0
0
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd.
Query!
Timepoint [32]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [33]
0
0
Tmax,ss of Anti-B7-H3 Antibody
Query!
Assessment method [33]
0
0
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody.
Query!
Timepoint [33]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [34]
0
0
Tmax,ss of DXd
Query!
Assessment method [34]
0
0
Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd.
Query!
Timepoint [34]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [35]
0
0
Area Under the Steady State Concentration-Time Curve Over Dosing Interval t (AUCt,ss) of gocatamig
Query!
Assessment method [35]
0
0
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig.
Query!
Timepoint [35]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [36]
0
0
AUCt,ss of I-DXd
Query!
Assessment method [36]
0
0
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd.
Query!
Timepoint [36]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [37]
0
0
AUCt,ss of Anti-B7-H3 Antibody
Query!
Assessment method [37]
0
0
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody.
Query!
Timepoint [37]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [38]
0
0
AUCt,ss of DXd
Query!
Assessment method [38]
0
0
AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd.
Query!
Timepoint [38]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [39]
0
0
Steady state t1/2 (t1/2,ss) of gocatamig
Query!
Assessment method [39]
0
0
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug gocatamig.
Query!
Timepoint [39]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [40]
0
0
t1/2,ss of I-DXd
Query!
Assessment method [40]
0
0
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug I-DXd.
Query!
Timepoint [40]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [41]
0
0
t1/2,ss of Anti-B7-H3 Antibody
Query!
Assessment method [41]
0
0
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the anti-B7-H3 antibody.
Query!
Timepoint [41]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [42]
0
0
t1/2,ss of DXd
Query!
Assessment method [42]
0
0
t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug payload DXd.
Query!
Timepoint [42]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [43]
0
0
Accumulation Ratio (AC) of gocatamig
Query!
Assessment method [43]
0
0
Blood samples will be collected to determine the AC of the drug gocatamig.
Query!
Timepoint [43]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [44]
0
0
AC of I-DXd
Query!
Assessment method [44]
0
0
Blood samples will be collected to determine the AC of the drug I-DXd.
Query!
Timepoint [44]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [45]
0
0
AC of Anti-B7-H3 Antibody
Query!
Assessment method [45]
0
0
Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.
Query!
Timepoint [45]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [46]
0
0
AC of DXd
Query!
Assessment method [46]
0
0
Blood samples will be collected to determine the AC of the drug payload DXd.
Query!
Timepoint [46]
0
0
At designated timepoints (up to approximately 44 months)
Query!
Secondary outcome [47]
0
0
Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig
Query!
Assessment method [47]
0
0
Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.
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Timepoint [47]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [48]
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0
Incidence of ADAs Against I-DXd
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Assessment method [48]
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0
Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.
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Timepoint [48]
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0
At designated timepoints (up to approximately 44 months)
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Secondary outcome [49]
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0
Incidence of ADAs Against Durvalumab
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Assessment method [49]
0
0
Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented.
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Timepoint [49]
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0
At designated timepoints (up to approximately 44 months)
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Eligibility
Key inclusion criteria
* Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
* Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
* History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
* Active clinically significant infection requiring systemic therapy
* History of allogeneic tissue/solid organ transplant
* History of leptomeningeal disease
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Untreated or symptomatic brain metastases
* Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV] deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
* Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
* Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
* Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention
* Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
* Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
* Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
* Part 1 only: Clinically significant corneal disease
* Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/08/2029
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Actual
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Sample size
Target
242
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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0
Princess Alexandra Hospital ( Site 5300) - Wooloongabba
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Recruitment postcode(s) [1]
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0
4102 - Wooloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Massachusetts
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Country [2]
0
0
United States of America
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State/province [2]
0
0
New Jersey
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0
0
United States of America
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State/province [3]
0
0
Tennessee
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Country [4]
0
0
Chile
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State/province [4]
0
0
Region M. De Santiago
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Country [5]
0
0
Israel
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State/province [5]
0
0
Haifa
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Country [6]
0
0
Israel
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State/province [6]
0
0
Jerusalem
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Country [7]
0
0
Israel
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State/province [7]
0
0
Ramat Gan
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Country [8]
0
0
Japan
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State/province [8]
0
0
Osaka
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Country [9]
0
0
Japan
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State/province [9]
0
0
Tokyo
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Country [10]
0
0
Korea, Republic of
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State/province [10]
0
0
Seoul
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0
0
Spain
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State/province [11]
0
0
Barcelona
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Country [12]
0
0
Spain
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State/province [12]
0
0
Madrid, Comunidad De
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Country [13]
0
0
Spain
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State/province [13]
0
0
Malaga
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Daiichi Sankyo
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
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Trial website
https://clinicaltrials.gov/study/NCT06780137
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Medical Director
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Address
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0
Merck Sharp & Dohme LLC
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0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
Toll Free Number
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Address
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0
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0
0
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Phone
0
0
1-888-577-8839
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06780137
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