Skip to content
Back to search

NCT06793215Recruiting

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

Summary

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).

Eligibility criteria

Inclusion Criteria: • 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 Criteria Related to NSCLC: • Known concomitant second oncogenic driver with available targeted treatment • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases • 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 • History of leptomeningeal disease • Uncontrolled tumor-related pain • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently) Exclusion Criteria Related to Current or Prior Treatments: • 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 • Current treatment with medications that are well known to prolong the QT interval • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to randomization • Prior allogeneic stem cell or solid organ transplantation Exclusion Criteria Related to General Health: • 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 • Significant cardiovascular disease within 3 months prior to screening

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
Phase 3
Study type
Interventional
Countries
Switzerland, France, Germany, Italy, United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, Greece, Hong Kong, Hungary, Ireland, Japan, Mexico, Netherlands, New Zealand, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom
Sponsor
Hoffmann-La Roche(Industry)
Protocol no.
CO45042
Conditions
Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
Interventions
Drug

Treatments studied

  • Divarasib
  • Pembrolizumab
  • Pemetrexed
  • Carboplatin
  • Cisplatin

Collaborators

Chugai Pharmaceutical

Locations · 285

  • Baden, SwitzerlandKantonsspital BadenRecruiting at this site
  • Basel, SwitzerlandUniversitaetsspital BaselRecruiting at this site
  • Chur, SwitzerlandKantonsspital Graubünden Medizin OnkologieRecruiting at this site
  • Geneva, SwitzerlandHôpital Universitaire de Genève (HUG)Recruiting at this site
  • Angers, FranceCHU AngersRecruiting at this site
  • Bobigny, FranceHopital AvicenneRecruiting at this site
  • Bron, FranceHôpital Louis Pradel, Hospices Civils de LyonRecruiting at this site
  • Caen, FranceCentre Francois BaclesseRecruiting at this site
  • Lyon, FranceCentre Leon BerardRecruiting at this site
  • Montpellier, FranceCHU MontpellierRecruiting at this site
  • Nice, FranceCentre Antoine LacassagneRecruiting at this site
  • Paris, FranceGroupe Hospitalier Paris Saint JosephRecruiting at this site
  • Paris, FranceHopital TenonRecruiting at this site
  • Pessac, FranceCHU BordeauxRecruiting at this site
  • Reims, FranceCentre Hospitalier Universitaire de ReimsRecruiting at this site
  • Saint-Quentin, FranceCH de Saint QuentinRecruiting at this site
  • Strasbourg, FranceCHU Strasbourg - Nouvel Hopital CivilRecruiting at this site
  • Vannes, FranceCentre Hospitalier Bretagne Atlantique VannesRecruiting at this site
  • Berlin, GermanyVivantes - Klinikum Im Friedrichshain;Innere Medizin ? Hämatologie, Onkologie und PalliativmedizinRecruiting at this site
  • Berlin, GermanyCharite - Universitätsmedizin BerlinRecruiting at this site
  • Berlin, GermanyHelios Klinikum Emil von Behring GmbHRecruiting at this site
  • Dresden, GermanyTechnische Universität Dresden - Medizinische Fakultät Carl Gustav Carus;Medizinische Klinik und Poliklinik IRecruiting at this site
  • Essen, GermanyKEM/Evang. Kliniken Essen Mitte gGmbHRecruiting at this site
  • Essen, GermanyUniversitätsklinikum EssenRecruiting at this site
  • Esslingen am Neckar, GermanyKlinikum EsslingenRecruiting at this site
  • Gauting, GermanyAsklepios Fachkliniken GmbHRecruiting at this site
  • Großhansdorf, GermanyLungenClinic Grosshansdorf GmbHRecruiting at this site
  • Halle, GermanyChristliches Klinikum Halle (Saale) GmbH, Standort DölauRecruiting at this site
  • Hamburg, GermanyUniversitätsklinikum Hamburg-EppendorfRecruiting at this site
  • Hamburg, GermanyAsklepios Klinik HarburgRecruiting at this site

In total, worldwide, 285 of the 288 sites listed in the registry are recruiting; the other 3 are not currently recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 6, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

+ 255 more locations

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.