Phase II study to evaluate immunotherapy-based combinations in advanced NSCLC
Research type
Research Study
Full title
A Phase II, Open-label, Platform Study, to evaluate Immunotherapy-based combinations in participants with advanced Non-Small Cell Lung Cancer
IRAS ID
1007550
Contact name
Pravina Kittredge
Contact email
Sponsor organisation
Arcus Biosciences
Clinicaltrials.gov Identifier
Research summary
Lung cancer is the most common form of cancer & leading cause of cancer death worldwide. Non-Small Cell Lung Cancer (NSCLC) represents approximately 80% of all lung cancer diagnoses & the vast majority present at an already advanced stage. The current available treatments have led to an increased clinical benefit, but not for all participants. The purpose of this study is to determine the safety and effectiveness of various zimberelimab-based immunotherapy combinations with or without chemotherapy in participants with NSCLC.
This type of study is a platform study & there will be 3 sub-studies (A, B and C) within the platform that will run in parallel.
Participants meeting all eligibility criteria will be assigned to a sub-study depending on their type of cancer and treatment history. Each sub-study will have 2 or 3 treatment groups, known as arms, & participants will be randomly assigned to 1 of the arms as follows:
Substudy A:
• Arm A1: zimberelimab + domvanalimab 800mg
• Arm A2: zimberelimab + domvanalimab 1200mg
• Arm A3: zimberelimab + quemliclustat
Substudy B:
• Arm B1: zimberelimab + quemliclustat + chemotherapy
• Arm B2: zimberelimab + domvanalimab + chemotherapy
• Arm B3: zimberelimab + domvanalimab + quemliclustat + chemotherapy
Substudy C:
• Arm C1: zimberelimab + quemliclustat + docetaxel
• Arm C2: zimberelimab + domvanalimab + docetaxel
The study is open label meaning the treatment is known to both the study doctor and participant.
Each sub-study will have 3 study periods: Screening, Treatment and Follow-up; length of participation will depend on when discontinuation criteria have been met. Assessments include physical examinations, vital signs, blood and urine sample collection for testing, electrocardiogram, tumour biopsy, CT and MRI scan and performance status.
Approximately 150 participants will participate worldwide with approximately 8 participants from 2 hospitals in the UK. The Sponsor of this study is Arcus Biosciences, Inc.REC name
Wales REC 3
REC reference
23/WA/0209
Date of REC Opinion
13 Oct 2023
REC opinion
Further Information Favourable Opinion