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
- Cracow, Gdansk, Kielce, Lublin, Olsztyn, Otwock, Poznan, Skorzewo, Torun, and Warsaw, PolandSee the 10 sites
- Phase
- Phase 2/3
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 Poland
- Pratia S.A.Cracow, PolandTaking people
- Uniwersyteckie Centrum KliniczneGdansk, PolandTaking people
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielce, PolandTaking people
- Ms Pneumed Janusz Milanowski Katarzyna Szmygin-Milanowska sp.j.Lublin, PolandTaking people
- Warminsko-Mazurskie Centrum Chorob Pluc w OlsztynieOlsztyn, PolandTaking people
- Mazowieckie Centrum Leczenia Chorob Pluc i GruzlicyOtwock, PolandTaking people
- Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza ZeylandowPoznan, PolandTaking people
- Pratia S.A.Skorzewo, PolandTaking people
- Wojewodzki Szpital Zespolony im. L. Rydygiera w ToruniuTorun, PolandTaking people
- National Institute Of Tuberculosis And Lung DiseasesWarsaw, PolandTaking 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.