At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Divarasib (drug), Pembrolizumab (drug), Carboplatin (drug), Cisplatin (drug)
- How long the study runs
- Study runs about 103 months (dates as stated)
- About the drug or intervention
- Divarasib — drug: Participants will receive divarasib orally (PO), QD on days 1-21 of each 21-day cycle. · Pembrolizumab — drug: Participants will receive a 200 mg IV infusion of pembrolizumab Q3W on Day 1 of each 21-day cycle. · Carboplatin — drug: Participants will receive IV carboplatin Q3W for four 21-day cycles. · Cisplatin — drug: Participants will receive IV cisplatin Q3W for four 21-day cycles. · Pemetrexed — drug: Participants will receive IV pemetrexed Q3W.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 320
- Started
- 2023-06-20
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for non-small cell lung cancer
- • Phase1/Phase2 - 320 participants
- • The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small cell lung cancer
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre
- • London - Barts & London School of Med
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ for all participants enrolled on study
- ✓ local therapy at the time of enrollment
What the study is looking for
- ✓Confirmation of test result eligibility
- ✓activity scale (ECOG) performance status (PS) of 0 or 1
- ✓Histologically or cytologically documented that has grown locally unresectable or that has spread NSCLC that is not eligible...
- ✓No prior systemic treatment for advanced unresectable or that has spread NSCLC
Who cannot take part
- ✗Known concomitant second oncogenic driver with available targeted treatment
- ✗Squamous cell histology NSCLC
- ✗causing symptoms, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)
- ✗Prior treatment with a KRAS G12C inhibitor
- ✗Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to...
See the full criteria
Where Is This Study? (2 UK sites)
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Barts & London School of Med
London EC1A 7BE, United Kingdom
How to Get in Touch
Reference Study ID Number: BO44426 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT
