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 (saale), Hamburg, Hanover, Heidelberg, Homburg, Immenhausen, Karlsruhe, Leipzig, Loewenstein, Luebeck, Mannheim, Muenster, Munich, Oldenburg, Regensburg, Tuebingen, and Wuerzburg, GermanySee the 27 sites
- Phase
- Phase 3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
- Helios Klinikum Emil von Behring GmbHBerlin, GermanyTaking people
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyTaking people
- Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyTaking people
- Asklepios Klinik Gauting GmbHGauting, GermanyTaking people
- LungenClinic Grosshansdorf GmbHGrosshansdorf, GermanyTaking people
- Martha-Maria Krankenhaus Halle-Doelau gGmbHHalle (saale), GermanyTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
- University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
- Klinikum Region Hannover GmbHHanover, GermanyTaking people
- Thoraxklinik Heidelberg gGmbHHeidelberg, GermanyTaking people
- Universitaetsklinikum des Saarlandes AöRHomburg, GermanyTaking people
- Lungenfachklinik ImmenhausenImmenhausen, GermanyTaking people
- Vincentius-Diakonissen-Kliniken gAGKarlsruhe, GermanyTaking people
- ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. TrinitatisLeipzig, GermanyTaking people
- SLK-Kliniken Heilbronn GmbHLoewenstein, GermanyTaking people
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyTaking people
- Universitaetsklinikum Mannheim GmbHMannheim, GermanyTaking people
- Universitaet MuensterMuenster, GermanyTaking people
- Muenchen Klinik gGmbHMunich, GermanyTaking people
- Pius Hospital OldenburgOldenburg, GermanyTaking people
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- Klinikum Wuerzburg Mitte gGmbHWuerzburg, 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
- F. Hoffmann-La Roche AG
- Trial code
- EU 2024-518365-10-00
- Record updated
- 6 October 2026
- Original description
To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to progression-free survival (PFS) and overall survival (OS)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
To evaluate the efficacy of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin with respect to progression-free survival (PFS) and overall survival (OS)
Inclusion: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, with assessment scale; Life expectancy of at least 12 weeks; Measurable disease, as defined by RECIST v1.1; No prior systemic treatment for advanced or metastatic non−small cell lung cancer (NSCLC); Documentation of the presence of a KRAS G12C mutation either through central laboratory testing of a tumor tissue sample (as per local IVD regulations), or preexisting test results of a blood or tumor tissue sample; Histologically or cytologically confirmed diagnosis of advanced or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy.
Exclusion: Known concomitant second oncogenic driver with available targeted treatment; Prior treatment with KRAS G12C inhibitors or pan-KRAS/RAS inhibitors; Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the study; Palliative radiation to bone metastases within 2 weeks prior to randomization to ensure adequate recovery from the effects of radiotherapy; Significant cardiovascular disease within 3 months prior to screening; Symptomatic, untreated, or actively progressing CNS metastases.