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Looking for participantsPhase3

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

Sponsor: Mirati Therapeutics Inc.

NCT ID: NCT06875310

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), Pembrolizumab (drug), Carboplatin (drug), Pemetrexed (drug)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Adagrasib — drug: Specified dose on specified days · Pembrolizumab — drug: Specified dose on specified days · Carboplatin — drug: Specified dose on specified days · Pemetrexed — drug: Specified dose on specified days · Placebo — drug: Specified dose on specified days · Cisplatin — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
630
Started
2025-04-24
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for carcinoma, non-small-cell lung
  • • Phase3 - 630 participants
  • • This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with carcinoma, non-small-cell lung

Where?

  • • London - University College London Hospital
  • • London - Guy's & St Thomas' NHS Foundation Trust
  • • Birmingham - Heartlands Hospital
  • • Guildford - Local Institution - 0545
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation

Carcinoma, Non-Small-Cell Lung

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

What the study is looking for

  • ✓confirmed by testing a sample diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via...
  • ✓that has grown locally or that has spread disease.
  • ✓cancer that can be measured on scans via computed tomography (CT) or magnetic resonance imaging (MRI) per (standard scan measurements) criteria of at...
  • ✓No prior systemic anti-cancer therapy given for advanced or that has spread disease.
  • ✓Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection).

Who cannot take part

  • ✗Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years.
  • ✗Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with...
  • ✗Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities.
  • ✗Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to...
  • ✗Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting.
See the full criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria of at least 1 lesion. * No prior systemic anti-cancer therapy given for advanced or metastatic disease. * Not a candidate for definitive therapy (eg, chemoradiation or complete surgical resection). * Participants with brain metastases are eligible for enrollment, including those with untreated brain metastases. Brain metastases must be asymptomatic and not in need of immediate local therapy. Any untreated brain metastases must be ≤ 20 mm in diameter. * Any PD-L1 expression (0 to 100%) as determined by VENTANA PD-L1 (SP263) assay, Agilent PD-L1 IHC 22C3 pharmDx, or Agilent PD-L1 IHC 28-8 pharmDx. Exclusion Criteria: * Participants with an active autoimmune or inflammatory disease requiring systemic treatment within 2 years. * Uncontrolled or significant cardiovascular conditions within 6 months prior to enrollment that are ongoing or with risk of recurrence. * Inadequate bone marrow or liver function or electrocardiogram (ECG) abnormalities. * Ongoing treatment with concomitant medication known to cause prolonged QTc interval and that cannot be switched to alternative treatment prior to study entry. * Treatment targeting KRAS G12C mutation (eg, sotorasib, adagrasib) in any setting. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (6 UK sites)

University College London Hospital

London NW1 2PG, United Kingdom

Recruiting
Site contact (verified)
Siow Lee, Site 0088442034479091

Guy's & St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Site contact (verified)
Alexandros Georgiou, Site 009100442071882006

Heartlands Hospital

Birmingham B9 5SS, United Kingdom

Recruiting
Site contact (verified)
Shobhit Baijal, Site 0092+(44)01214247456

Local Institution - 0545

Guildford GU2 7XX, United Kingdom

WITHDRAWN

The Royal Surrey County Hospital

Guildford GU2 7XX, United Kingdom

Recruiting
Site contact (verified)
Ajay Mehta, Site 0090441483571122

Local Institution - 0093

Manchester M20 4BX, United Kingdom

WITHDRAWN

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