Tests divarasib with pembrolizumab in untreated lung cancer with KRAS G12C
Compares divarasib and pembrolizumab with standard chemotherapy plus pembrolizumab in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
Key facts
- Where
- Berlin, Dresden, Essen, Esslingen am Neckar, Gauting, Großhansdorf, Halle, Hamburg, Hanover, Heidelberg, Homburg, Immenhausen, Karlsruhe, Löwenstein, Lübeck, Mannheim, München, Münster, Oldenburg, Regensburg, Tübingen, and Würzburg, GermanySee the 26 sites
- Phase
- Phase 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?
- Can you look after yourself and are you up and about most of the day?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT06793215, who can take part
Where in Germany
- Charité Universitätsmedizin BerlinBerlin, GermanyTaking people
- Helios Klinikum Emil von Behring GmbHBerlin, GermanyTaking people
- Vivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und PalliativmedizinBerlin, GermanyTaking people
- Technische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik IDresden, GermanyTaking people
- KEM/Evang. Kliniken Essen Mitte gGmbHEssen, GermanyTaking people
- Universitätsklinikum EssenEssen, GermanyTaking people
- Klinikum EsslingenEsslingen am Neckar, GermanyTaking people
- Asklepios Fachkliniken GmbHGauting, GermanyTaking people
- LungenClinic Grosshansdorf GmbHGroßhansdorf, GermanyTaking people
- Christliches Klinikum Halle (Saale) GmbH, Standort DölauHalle, GermanyTaking people
- Asklepios Klinik HarburgHamburg, GermanyTaking people
- Universitätsklinikum Hamburg-EppendorfHamburg, GermanyTaking people
- KRH Klinikum Siloah-Oststadt-HeidehausHanover, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Universität Des SaarlandesHomburg, GermanyTaking people
- Lungenfachklinik ImmenhausenImmenhausen, GermanyTaking people
- ViDia Christliche Kliniken Karlsruhe;Medizinische Klinik 2, Studienzentrale Prof. MzB. / Raum G.018Karlsruhe, GermanyTaking people
- SLK Kliniken Heilbronn GmbH, Standort Fachklinik LöwensteinLöwenstein, GermanyTaking people
- Universitätsklinikum Schleswig-HolsteinLübeck, GermanyTaking people
- Universität MannheimMannheim, GermanyTaking people
- Klinikum BogenhausenMünchen, GermanyTaking people
- Universitaetsklinikum MuensterMünster, GermanyTaking people
- Pius Hospital OldenburgOldenburg, GermanyTaking people
- Universitätsklinikum RegensburgRegensburg, GermanyTaking people
- Universitätsklinikum TübingenTübingen, GermanyTaking people
- Klinikum Würzburg Mitte gGmbHWürzburg, GermanyTaking 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
- Hoffmann-La Roche
- Trial code
- NCT06793215
- Record updated
- 5 November 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).Read full original descriptionShow less
A Phase III, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Patients With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Inclusion: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy; Measurable disease, as defined by RECIST v1.1; No prior systemic treatment for advanced or metastatic NSCLC; Documentation of the presence of a KRAS G12C mutation; Documentation of known PD-L1 expression status in tumor tissue; Availability of a representative tumor specimen; Adequate end-organ function; Eligible to receive a platinum-based chemotherapy regimen.
Exclusion: Known concomitant second oncogenic driver with available targeted treatment; Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization; Any anti-cancer systemic therapy, including hormonal therapy, within 21 days prior to randomization, or is expected to require any other form of antineoplastic therapy while in the study; Radiation therapy including palliative RT to bone metastases within 2 weeks prior to randomization and RT to the lung >30Gy within 6 months prior to randomization; Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors; Treatment with systemic immunosuppressive or immunostimulatory medications, including CD137 agonists and immune checkpoint inhibitors; Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization; Prior allogeneic stem cell or solid organ transplantation; Significant cardiovascular disease within 3 months prior to screening; History of leptomeningeal disease; History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival [OS] rate >90%), such as adequately treated carcinoma in situ of the cervix, non melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer; Individuals with chronic diarrhea, short bowel syndrome or significant upper gastrointestinal surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis), malabsorption syndrome, conditions that would interfere with enteral absorption; History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography scan; Current treatment with medications that are well known to prolong the QT interval; Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases; Uncontrolled tumor-related pain; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently).