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Looking for participantsPhase2/Phase3

Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

Sponsor: Mirati Therapeutics Inc.

NCT ID: NCT04613596

View on ClinicalTrials.gov ↗

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.

Advanced Non-Small Cell Lung CancerMetastatic Non-Small Cell Lung Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

KRASPD-L1

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
Inclusion Criteria: * Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS * Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\>=50% * Phase 3: Presence of measurable disease per RECIST1.1 * Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following: 1. No evidence of brain metastases 2. Untreated brain metastases not needing immediate local therapy 3. Previously treated brain metastases not needing immediate local therapy Exclusion Criteria: * Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). * Phase 2: Active brain metastases * Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following: 1. Any untreated brain lesions \> 2.0 cm in size 2. Any brainstem lesions 3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \> 10 mg of prednisone (or equivalent) prior to randomization. 4. Have poorly controlled (\> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy * Phase 3: Radiation to the lung \> 30 Gy within 6 months prior to the first dose of study treatment

Where Is This Study? (8 UK sites)

University Hospitals Birmingham NHS Foundation Trust

Birmingham B9 5SS, United Kingdom

Recruiting
Site contact (verified)
Shobhit Baijal, Site 007-410+(44)01214247456

Local Institution - 007-415

Edinburgh EH4 2XU, United Kingdom

WITHDRAWN

Local Institution - 007-403

Kent ME16 9QQ, United Kingdom

NOT_YET_RECRUITING

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

University College London Hospitals NHS Foundation Trust

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Siow-Ming Lee, Site 007-402+442034479091

Guys and St Thomas NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Alexandros Georgiou, Site 007-40900442071882006

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Colin Lindsay, Site 007-407+441614463745

Royal Surrey County Hospital NHS Foundation Trust

Surrey GU2 7XX, United Kingdom

Recruiting
Site contact (verified)
Ajay Mehta, Site 007-419441483571122

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09