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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06623422
Registration number
NCT06623422
Ethics application status
Date submitted
5/09/2024
Date registered
2/10/2024
Date last updated
14/07/2025
Titles & IDs
Public title
A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
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Scientific title
A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)
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Secondary ID [1]
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2023-506327-29-00
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Secondary ID [2]
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V940-009
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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:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Gemcitabine
Treatment: Drugs - Paclitaxel
Treatment: Other - Intismeran autogene
Other interventions - Placebo
Experimental: Pembrolizumab + Intismeran autogene - For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via intravenous (IV) infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC\] 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS intismeran autogene 1 mg via intramuscular (IM) injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Active comparator: Pembrolizumab + Placebo - For neoadjuvant treatment, participants will receive pembrolizumab 200 mg via IV infusion every 3-week cycle for up to 4 cycles PLUS background chemotherapy via IV infusion (cisplatin 75 mg/m\^2 or carboplatin AUC 5 or 6 mg/mL/min, pemetrexed 500 mg/m\^2, gemcitabine 1000 mg/m\^2, paclitaxel 175 mg/m\^2 or 200 mg/m\^2 given at a dose and combination per investigator's choice) every 3-week cycle for up to 4 cycles (total neoadjuvant treatment duration of up to \~12 weeks). After surgical resection, for adjuvant treatment, participants will receive pembrolizumab 400 mg via IV infusion every 6-week cycle for up to 7 cycles PLUS matching placebo via IM injection every 3 weeks for up to 9 doses (total adjuvant treatment duration of up to \~42 weeks).
Treatment: Other: Pembrolizumab
IV Infusion
Treatment: Drugs: Cisplatin
IV infusion
Treatment: Drugs: Carboplatin
IV infusion
Treatment: Drugs: Pemetrexed
IV infusion
Treatment: Drugs: Gemcitabine
IV infusion
Treatment: Drugs: Paclitaxel
IV infusion
Treatment: Other: Intismeran autogene
IM injection
Other interventions: Placebo
IM injection
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Intervention code [3]
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Other interventions
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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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Disease-Free Survival (DFS)
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Assessment method [1]
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DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, as assessed by the investigator, or death due to any cause, whichever occurs first.
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Timepoint [1]
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Up to ~97 months
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization to death due to any cause.
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Timepoint [1]
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Up to ~129 months
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Secondary outcome [2]
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Distant Metastasis-Free Survival (DMFS)
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Assessment method [2]
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DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis as assessed by the investigator, or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes.
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Timepoint [2]
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Up to ~129 months
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Secondary outcome [3]
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Disease-Free Survival 2 (DFS2)
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Assessment method [3]
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DFS2 is defined as the time from randomization to subsequent recurrence or disease progression after initiation of next-line anticancer therapy as assessed by the investigator, or death due to any cause, whichever occurs first.
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Timepoint [3]
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Up to ~129 months
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Secondary outcome [4]
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Lung Cancer Specific Survival (LCSS)
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Assessment method [4]
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LCSS is defined as the time from randomization to death due to lung cancer specifically as assessed by the investigator.
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Timepoint [4]
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Up to ~129 months
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Secondary outcome [5]
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Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30)
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Assessment method [5]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" will be scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a better overall health status. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
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Timepoint [5]
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Baseline and up to ~129 months
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Secondary outcome [6]
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Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5)
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Assessment method [6]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. Higher scores indicate a worse level of physical functioning. The change from baseline in physical functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
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Timepoint [6]
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Baseline and up to ~129 months
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Secondary outcome [7]
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Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7)
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Assessment method [7]
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The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of role functioning. Change from baseline in the role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.
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Timepoint [7]
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Baseline and up to ~129 months
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Secondary outcome [8]
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Number of participants with =1 adverse event (AE)
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Assessment method [8]
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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.
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Timepoint [8]
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Up to ~129 months
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Secondary outcome [9]
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Number of participants discontinuing from study therapy due to AE(s)
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Assessment method [9]
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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.
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Timepoint [9]
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Up to ~129 months
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Eligibility
Key inclusion criteria
The main inclusion criteria include but are not limited to the following:
* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition]
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention
* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible
* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R])
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
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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
The main exclusion criteria include but are not limited to the following:
* Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor
* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
* Received prior neoadjuvant therapy for their current NSCLC diagnosis
* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137)
* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol
* Received prior treatment with a cancer vaccine
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
21/10/2024
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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
26/01/2038
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Actual
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Sample size
Target
680
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Calvary Mater Newcastle ( Site 2106) - Waratah
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Recruitment hospital [2]
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Tasman Oncology Research ( Site 2104) - Southport
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Princess Alexandra Hospital ( Site 2102) - Wooloongabba
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Grampians Health ( Site 2101) - Ballarat
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Recruitment hospital [5]
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One Clinical Research ( Site 2103) - Nedlands
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Recruitment postcode(s) [1]
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2298 - Waratah
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Recruitment postcode(s) [2]
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4215 - Southport
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4102 - Wooloongabba
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Recruitment postcode(s) [4]
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3350 - Ballarat
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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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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Commercial sector/industry
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ModernaTX, Inc.
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Ethics approval
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Summary
Brief summary
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
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Trial website
https://clinicaltrials.gov/study/NCT06623422
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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1-888-577-8839
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[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/NCT06623422
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