NCT05789082Recrutement en cours
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation
Résumé
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
Critères d'inclusion
• Confirmation of Biomarker eligibility • Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor. • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 • Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy • No prior systemic treatment for advanced unresectable or metastatic NSCLC • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.
Critères d'exclusion
• Known concomitant second oncogenic driver with available targeted treatment • Squamous cell histology NSCLC • Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C) • Prior treatment with a KRAS G12C inhibitor • Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only) • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment • History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \>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 • Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia • Co-morbid condition that is an absolute contraindication to treatment with corticosteroids • Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation. • Participants with brain metastases for whom complete surgical resections is clinically appropriate
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 1 · Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse, Italie, États-Unis, Argentine, Australie, Belgique, Brésil, Canada, Chine, Israël, Japon, Pays-Bas, Pologne, Corée du Sud, Espagne, Suède, Taïwan, Royaume-Uni
- Promoteur
- Hoffmann-La Roche(Industrie)
- N° de protocole
- BO44426
- Pathologies
- Non-Small Cell Lung Cancer
- Interventions
- Médicament
Traitements évalués
- Divarasib
- Pembrolizumab
- Carboplatin
- Cisplatin
- Pemetrexed
Lieux · 57
- Basel, SuisseUniversitätsspital BaselRecrute dans ce centre
- Milan, ItalieIrccs Istituto Nazionale Dei Tumori (Int)Recrute dans ce centre
- Orbassano, ItalieA.O. Universitaria S. Luigi GonzagaRecrute dans ce centre
- New Haven, États-UnisYale Cancer CenterRecrute dans ce centre
- Fort Myers, États-UnisFlorida Cancer Specialists - SOUTH - SCRI - PPDSRecrute dans ce centre
- St. Petersburg, États-UnisFlorida Cancer Specialists - NORTH - SCRI - PPDSRecrute dans ce centre
- West Palm Beach, États-UnisFlorida Cancer Specialists - EAST - SCRI - PPDSRecrute dans ce centre
- Mineola, États-UnisNYU Langone Hospital - Long IslandRecrute dans ce centre
- New York, États-UnisNYU Cancer CenterRecrute dans ce centre
- New York, États-UnisMount SInai Medical CenterRecrute dans ce centre
- The Bronx, États-UnisMontefiore Medical Center - Montefiore Medical ParkRecrute dans ce centre
- Houston, États-UnisMD Anderson Cancer CenterRecrute dans ce centre
- Blacksburg, États-UnisOncology & Hematology Associates of Southwest Virginia, IncRecrute dans ce centre
- Norfolk, États-UnisVirginia Oncology AssociatesRecrute dans ce centre
- Buenos Aires, ArgentineHospital BritanicoRecrute dans ce centre
- Ciudad Autonoma Buenos Aires, ArgentineClinica Adventista BelgranoRecrute dans ce centre
- La Rioja, ArgentineCentro Oncologico Riojano Integral (CORI)Recrute dans ce centre
- Melbourne, AustraliePeter MacCallum Cancer CentreRecrute dans ce centre
- Melbourne, AustralieAlfred HealthRecrute dans ce centre
- Brussels, BelgiqueCliniques Universitaires St-LucRecrute dans ce centre
- Hasselt, BelgiqueJessa Zkh (Campus Virga Jesse)Recrute dans ce centre
- Namur, BelgiqueClinique Ste-ElisabethRecrute dans ce centre
- Roeselare, BelgiqueAZ Delta (Campus Rumbeke)Recrute dans ce centre
- Barretos, BrésilHospital de Cancer de BarretosRecrute dans ce centre
- São Paulo, BrésilInstituto do Cancer do Estado de Sao Paulo - ICESPRecrute dans ce centre
- Ottawa, CanadaOttawa Hospital Regional Cancer CentreRecrute dans ce centre
- Montreal, CanadaJewish General HospitalRecrute dans ce centre
- Changsha, ChineHunan Cancer HospitalRecrute dans ce centre
- Harbin, ChineHarbin Medical University Cancer HospitalRecrute dans ce centre
- Shanghai, ChineShanghai Pulmonary HospitalRecrute dans ce centre
Au total, dans le monde, 57 des 71 centres listés au registre recrutent ; les 14 autres ne recrutent pas actuellement.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 6 octobre 2026).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
+ 27 autres lieux
Autres identifiants
- 2022-003048-28 · n° EudraCT
- 2023-507171-22-00 · n° CTIS
- 2023 · financement NIH
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.