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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05553808




Registration number
NCT05553808
Ethics application status
Date submitted
21/09/2022
Date registered
23/09/2022
Date last updated
19/01/2023

Titles & IDs
Public title
Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC) - Sub-study 1
Scientific title
A Phase II, Randomized, Open-label Platform Trial Utilizing a Master Protocol to Study Novel Regimens Versus Standard of Care Treatment in NSCLC Participants
Secondary ID [1] 0 0
2018-001316-29
Secondary ID [2] 0 0
205801-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Feladilimab

Active Comparator: Docetaxel -

Experimental: Feladilimab plus Docetaxel -


Treatment: Drugs: Docetaxel
Docetaxel was administered as IV infusion.

Treatment: Drugs: Feladilimab
Feladilimab was administered as IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Kaplan-Meier Estimates of Overall Survival at 12 and 18 Months
Timepoint [1] 0 0
Month 12 and 18
Secondary outcome [2] 0 0
Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD) or Not Evaluable
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Kaplan-Meier Estimates of Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Objective Response Rate
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
Kaplan-Meier Estimates of Duration of Response (DOR) in Participants With Objective Response
Timepoint [5] 0 0
Up to 2 years
Secondary outcome [6] 0 0
Disease Control Rate (DCR)
Timepoint [6] 0 0
Up to 2 years
Secondary outcome [7] 0 0
Number of Participants With iRECIST Complete Response (iCR), Partial Response (iPR), Unconfirmed Progressive Disease (iUPD), Confirmed Progressive Disease (iCPD), Stable Disease (iSD) or Not Evaluable
Timepoint [7] 0 0
Up to 2 years
Secondary outcome [8] 0 0
Kaplan-Meier Estimates of iRECIST Progression-free Survival (iPFS)
Timepoint [8] 0 0
Up to 2 years
Secondary outcome [9] 0 0
iRECIST Objective Response Rate (iORR)
Timepoint [9] 0 0
Up to 2 years
Secondary outcome [10] 0 0
Kaplan-Meier Estimates of iRECIST Duration of Response (iDOR) in Participants With Objective Response
Timepoint [10] 0 0
Up to 2 years
Secondary outcome [11] 0 0
Number of Participants With AEs, Adverse Events of Special Interest (AESI), SAEs and AE/SAEs Leading to Dose Modifications/Delays/Withdrawals
Timepoint [11] 0 0
Up to 2 years
Secondary outcome [12] 0 0
Number of Participants With Maximum Grade Increase in Clinical Chemistry Parameters at Worst Case Post-Baseline
Timepoint [12] 0 0
Up to 2 years
Secondary outcome [13] 0 0
Number of Participants With Maximum Grade Increase in Hematology Parameters at Worst Case Post-Baseline
Timepoint [13] 0 0
Up to 2 years
Secondary outcome [14] 0 0
Number of Participants With Maximum Grade Increase in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure) Parameters at Worst Case Post-Baseline
Timepoint [14] 0 0
Up to 2 years
Secondary outcome [15] 0 0
Number of Participants With Vital Signs (Temperature) Parameter Results at Worst Case Post-Baseline
Timepoint [15] 0 0
Up to 2 years
Secondary outcome [16] 0 0
Number of Participants With Vital Signs (Pulse Rate) Parameter Results at Worst Case Post-Baseline
Timepoint [16] 0 0
Up to 2 years
Secondary outcome [17] 0 0
Minimum Observed Concentration (CmIn) of Feladilimab
Timepoint [17] 0 0
Week 1
Secondary outcome [18] 0 0
Maximum Observed Concentration (Cmax) of Feladilimab
Timepoint [18] 0 0
Week 1, Week 13 and Week 25
Secondary outcome [19] 0 0
Maximum Observed Concentration (Cmax) of Docetaxel
Timepoint [19] 0 0
Week 1, Week 4, Week 7, Week 10, Week 13, Week 16, Week 19 and Week 22
Secondary outcome [20] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) Against Docetaxel
Timepoint [20] 0 0
Up to 2 years
Secondary outcome [21] 0 0
Number of Participants With Positive ADA Against Feladilimab
Timepoint [21] 0 0
Week 1, 4, 7, 10, 13, 16, 19, 22, 25, 37, 49, 61 and 73

Eligibility
Key inclusion criteria
* Participants capable of giving signed informed consent/assent.
* Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
* Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and

a) Documented disease progression based on radiographic imaging, during or after a maximum of 2 lines of systemic treatment for locally/regionally advanced recurrent, Stage IIIb/Stage IIIc/Stage IV or metastatic disease. Two components of treatment must have been received in the same line or as separate lines of therapy: i) No more than or less than 1 line of platinum-containing chemotherapy regimen, and ii) No more than or less than 1 line of Programmed cell death ligand 1 (PD[L]1) monoclonal antibody (mAb) containing regimen.

b) Participants with known BRAF molecular alterations must have had disease progression after receiving the locally available SoC treatment for the molecular alteration.

c) Participants who received prior anti-PD(L)1 therapy must fulfill the following requirements: i) Have achieved a CR, PR or SD and subsequently had disease progression (per RECIST 1.1 criteria) either on or after completing PD(L)1 therapy ii) Have not progressed or recurred within the first 12 weeks of PD(L)1 therapy, either clinically or per RECIST 1.1 criteria
* Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
* A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
* Adequate organ function as defined in the protocol.
* A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:

i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
* Life expectancy of at least 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):

1. Docetaxel at any time.
2. Any of the investigational agents being tested in the current study.
3. Systemic approved or investigational anticancer therapy within 30 days or 5 half-lives of the drug, whichever is shorter. At least 14 days must have elapsed between the last dose of prior anticancer agent and the first dose of study drug is administered.
4. Prior radiation therapy: permissible if at least one non-irradiated measurable lesion is available for assessment per RECIST version 1.1 or if a solitary measurable lesion was irradiated, objective progression is documented. A wash out of at least 2 weeks before start of study drug for radiation of any intended use is required.
* Received greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
* Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except

* Any other invasive malignancy for which the participant was definitively treated, has been disease-free for at least 2 years and in the opinion of the principal investigator and GlaxoSmithKline Medical Monitor will not affect the evaluation of the effects of the study treatment on the currently targeted malignancy, may be included in this clinical trial.
* Curatively treated non-melanoma skin cancer or successfully treated in situ carcinoma.
* Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
* Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
* Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
* Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
* Prior allogeneic/autologous bone marrow or solid organ transplantation.
* Receipt of any live vaccine within 30 days prior to first dose of study treatment.
* Toxicity from previous anticancer treatment that includes:

1. Greater than or equal to (>=) Grade 3 toxicity considered related to prior immunotherapy and that led to treatment discontinuation.
2. Toxicity related to prior treatment that has not resolved to <= Grade 1 (except alopecia, hearing loss, endocrinopathy managed with replacement therapy, and peripheral neuropathy which must be <= Grade 2).
* History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
* Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
* Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
* History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include

1. Serious, uncontrolled cardiac arrhythmia or clinically significant electrocardiogram abnormalities including second degree (Type II) or third degree atrioventricular block.
2. Cardiomyopathy, myocardial infarction, acute coronary syndromes (including unstable angina pectoris), coronary angioplasty, stenting or bypass grafting.
3. Symptomatic pericarditis.
* Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
* Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
* Participants with known human immunodeficiency virus infection.
* Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
* Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
* Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
* Pregnant or lactating female participants.
* Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
* Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
* Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
* Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
* Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/09/2021
Sample size
Target
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
France
State/province [5] 0 0
Bordeaux Cedex
Country [6] 0 0
France
State/province [6] 0 0
Caen Cedex 9
Country [7] 0 0
France
State/province [7] 0 0
Nantes cedex 1
Country [8] 0 0
France
State/province [8] 0 0
Paris Cedex 05
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Villejuif Cedex
Country [11] 0 0
Germany
State/province [11] 0 0
Bayern
Country [12] 0 0
Germany
State/province [12] 0 0
Hessen
Country [13] 0 0
Germany
State/province [13] 0 0
Sachsen
Country [14] 0 0
Germany
State/province [14] 0 0
Schleswig-Holstein
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Italy
State/province [16] 0 0
Emilia-Romagna
Country [17] 0 0
Italy
State/province [17] 0 0
Lombardia
Country [18] 0 0
Italy
State/province [18] 0 0
Piemonte
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Cheongju-si
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Gyeonggi-do
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seongnam
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Netherlands
State/province [23] 0 0
Maastricht
Country [24] 0 0
Poland
State/province [24] 0 0
Lodz
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Poland
State/province [26] 0 0
Warszawa
Country [27] 0 0
Romania
State/province [27] 0 0
Bucharest
Country [28] 0 0
Romania
State/province [28] 0 0
Craiova
Country [29] 0 0
Romania
State/province [29] 0 0
Floresti
Country [30] 0 0
Romania
State/province [30] 0 0
Otopeni
Country [31] 0 0
Romania
State/province [31] 0 0
Timisoara
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Chelyabinsk
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Saint-Petersburg
Country [34] 0 0
Spain
State/province [34] 0 0
Barcelona
Country [35] 0 0
Spain
State/province [35] 0 0
Madrid
Country [36] 0 0
Spain
State/province [36] 0 0
Santander
Country [37] 0 0
Spain
State/province [37] 0 0
Sevilla
Country [38] 0 0
Sweden
State/province [38] 0 0
Uppsala

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
iTeos Belgium SA
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study has assessed the clinical activity of novel regimen (Feladilimab plus Docetaxel) with SOC (Docetaxel) in participants with NSCLC.
Trial website
https://clinicaltrials.gov/study/NCT05553808
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05553808