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Taking people in BrazilPhase 2/3

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
Barretos, Florianópolis, Ijuí, Lajeado, Natal, Porto Alegre, Rio de Janeiro, Salvador, São José do Rio Preto, and São Paulo, BrazilSee the 13 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 12 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 Brazil

  • Fundação Pio XII - Hospital de Câncer de Barretos - Hospital de AmorBarretos, BrazilContact: Josiane Mourao Dias, Site 007-457Taking people
  • Local Institution - Unk060Barretos, BrazilNo longer taking part
  • CEPON - Centro de Pesquisas OncologicasFlorianópolis, BrazilTaking people
  • Local Institution - Unk002Ijuí, BrazilNo longer taking part
  • Local Institution - Unk050Lajeado, BrazilNo longer taking part
  • Liga Contra o Câncer - Centro Avançado de OncologiaNatal, BrazilContact: Joilda Rego, Site 007-458Taking people
  • Hospital Nossa Senhora da ConceiçãoPorto Alegre, BrazilContact: Juliana de Menezes, Site 007-459Taking people
  • Local Institution - 007-5052Porto Alegre, BrazilNot yet recruiting
  • Local Institution - Unk015Porto Alegre, BrazilNo longer taking part
  • Local Institution - Unk003Rio de Janeiro, BrazilNo longer taking part
  • Hospital Santa IzabelSalvador, BrazilTaking people
  • Local Institution - Unk019São José do Rio Preto, BrazilNo longer taking part
  • Local Institution - Unk074São Paulo, BrazilNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT04613596 · EU CTIS 2023-508922-83-00