Tests adagrasib alone and with pembrolizumab in lung cancer with a KRAS G12C change
Tests adagrasib, alone or with pembrolizumab, in adults with lung cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- 's-Gravenhage, Amsterdam, Dordrecht, Harderwijk, Nijmegen, and Schiedam, NetherlandsSee the 6 sites
- Phase
- Phase 2/3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and who have not yet had treatment for it.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Non-small cell lung cancer that cannot be removed by surgery or has spread. Phase 3 asks for squamous or nonsquamous NSCLC with PD-L1 TPS of 50% or higher and measurable disease. Phase 2 accepts any PD-L1 TPS.
- Earlier treatment
- People cannot have had earlier systemic treatment for advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C (for example AMG 510).
- Biomarker or test result
- KRAS G12C mutation. Phase 3 also needs PD-L1 TPS of 50% or higher.
Main reasons for not taking part
- Earlier systemic treatment for advanced or metastatic NSCLC
- Phase 2: active brain metastases
- Phase 3: untreated brain lesions larger than 2.0 cm (0.8 in), or any brainstem lesions
- Phase 3: steroids above 10 mg of prednisone a day for brain lesion symptoms, or seizures more than 1 a week
- Phase 3: radiation to the lung above 30 Gy within 6 months before the first dose
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Which best describes your lung cancer?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
Source: NCT04613596, who can take part
Where in Netherlands
- Haga Hospital's-Gravenhage, NetherlandsTaking people
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, NetherlandsTaking people
- Albert Schweitzer ZiekenhuisDordrecht, NetherlandsTaking people
- Ziekenhuis St JansdalHarderwijk, NetherlandsTaking people
- Radboud universitair medisch centrum StichtingNijmegen, NetherlandsTaking people
- Sint Franciscus Vlietland Groep StichtingSchiedam, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mirati Therapeutics Inc.
- Trial code
- NCT04613596EU 2023-508922-83-00
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
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.
Inclusion: 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:; No evidence of brain metastases; Untreated brain metastases not needing immediate local therapy; Previously treated brain metastases not needing immediate local therapy.
Exclusion: 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 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 of prednisone (or equivalent) prior to randomization; 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; Phase 2: Active brain metastases.