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
- Adagrasib (drug), Adagrasib (drug), Adagrasib (drug), Adagrasib (drug)
- How long the study runs
- Study runs about 106 months (dates as stated)
- About the drug or intervention
- Adagrasib — drug: Adagrasib 400 mg twice daily (BID) in combination with pembrolizumab (Cohort 1a) · Adagrasib — drug: Adagrasib 600 mg BID monotherapy (Cohort 1b) · Adagrasib — drug: adagrasib 400 mg BID in combination with pembrolizumab · Adagrasib — drug: Adagrasib 400 mg BID + pembrolizumab 200 mg every Q3W · Pembrolizumab — drug: Pembrolizumab 200 mg IV 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
- 626
- Started
- 2020-12-02
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for advanced non-small cell lung cancer
- • Phase2/Phase3 - 626 participants
- • The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced non-small cell lung cancer
Where?
- • Birmingham - University Hospitals Birmingham NHS Foundation Trust
- • Edinburgh - Local Institution - 007-415
- • Kent - Local Institution - 007-403
- • Leicester - University Hospitals of Leicester NHS Trust
- • +4 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
More detail
The Phase 2 portion of this study will evaluate the efficacy and safety of MRTX849 as monotherapy and in combination with pembrolizumab. There will be 3 cohorts of patients, all of whom have KRAS G12C mutation, have advanced or metastatic NSCLC, and are candidates for first-line treatment. 2 cohorts have PD-L1 TPS score \<1% and are randomized to MRTX849 monotherapy or MRTX849 in combination with pembrolizumab. The 3rd cohort has PD-L1 TPS score of 1% or higher and is treated with MRTX849 and pembrolizumab The Phase 3 portion of the study will randomize patients with squamous or nonsquamous NSCLC with KRAS G12C mutation and TPS \>=50% in the first-line setting to adagrasib plus pembrolizumab or pembrolizumab. Primary efficacy objective is to compare efficacy between experimental and comparator arms. Secondary and exploratory objectives include evaluation of secondary efficacy endpoints, safety and tolerability, adagrasib PK, PROs, and correlative genomic biomarkers for the combination regimen in the study population. MRTX849 is an orally available small molecule inhibitor of KRAS G12C, and Pembrolizumab (KEYTRUDA®) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
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:
- ✓ one of the following:
What the study is looking for
- ✓Phase 2: confirmed by a biopsy diagnosis of unresectable or that has spread NSCLC with KRAS G12C mutation and any...
- ✓Phase 3: confirmed by a biopsy diagnosis of unresectable or that has spread squamous or nonsquamous NSCLC with KRAS...
- ✓Phase 3: Presence of cancer that can be measured on scans per RECIST1.1
- ✓Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:
- ✓No evidence of brain metastases
Who cannot take part
- ✗Phase 2: Active brain metastases
- ✗Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:
- ✗Any untreated brain lesions \> 2.0 cm in size
- ✗Any brainstem lesions
- ✗Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg...
See the full criteria
Where Is This Study? (8 UK sites)
University Hospitals Birmingham NHS Foundation Trust
Birmingham B9 5SS, United Kingdom
Local Institution - 007-415
Edinburgh EH4 2XU, United Kingdom
Local Institution - 007-403
Kent ME16 9QQ, United Kingdom
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Carolyn Maloney
uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351University College London Hospitals NHS Foundation Trust
London NW1 2BU, United Kingdom
Guys and St Thomas NHS Foundation Trust
London SE1 9RT, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Surrey GU2 7XX, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
First line of the email MUST contain NCT # and Site #.
Sponsor contactCONTACT
