NCT07541170RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)
A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 6 Oct 2026
- Primary completion date
- 31 Jan 2032
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Lung cancer, Sarcoma
- NCT number
- NCT07541170
- EU CT number
- 2025-524263-21-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 6 Oct 2026 to the primary completion date, 31 Jan 2032
- 119 sites in 20 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
- Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
- Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy
Other illness
- Active or history of autoimmune disease or immune deficiency
- Significant cardiovascular disease
Other
- Participants who achieve pCR following neoadjuvant treatment
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
- Participants must have had complete resection of NSCLC
- Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
- Participants must be randomized within 12 weeks of their surgery date
- No evidence of disease recurrence or metastatic disease
- Documentation of the presence of a KRAS G12C mutation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Argentino de Diagnóstico y Tratamiento- IADT Coordinator of this site? Confirm its status | Capital Federal | Argentina | Recruiting |
| Clinica Adventista Belgrano Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Centro Oncologico Korben Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Hospital Britanico Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Recruiting |
| Hospital Privado de Comunidad Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Recruiting |
| Sanatorio de la Mujer Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| Vorarlberger Krankenhaus-Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Feldkirch | Austria | Not yet recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Not yet recruiting |
| Universitaetsklinikum Krems Coordinator of this site? Confirm its status | Krems An Der Donau | Austria | Not yet recruiting |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Not yet recruiting |
| Universitair Ziekenhuis Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Not yet recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Not yet recruiting |
| CHU Helora Coordinator of this site? Confirm its status | Mons | Belgium | Not yet recruiting |
| Cenantron Centro Avançado de Tratamento Oncológico Coordinator of this site? Confirm its status | Belo Horizonte | Brazil | Recruiting |
| Clínica de Neoplasias Litoral Coordinator of this site? Confirm its status | Itajaí | Brazil | Recruiting |
| Hospital Sao Lucas - PUCRS Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Hospital Moinhos de Vento Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Beneficencia Portuguesa de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Guangdong General Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo Coordinator of this site? Confirm its status | Bogota, D.C. | Colombia | Recruiting |
| Clinica ASTORGA Coordinator of this site? Confirm its status | Medellín | Colombia | Recruiting |
| Vivantes Netzwerk fuer Gesundheit GmbH Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Evangelisches Klinikum Bethel gGmbH Coordinator of this site? Confirm its status | Bielefeld | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Recruiting |
| Klinikum Esslingen GmbH Coordinator of this site? Confirm its status | Esslingen am Neckar | Germany | Recruiting |
| Asklepios Klinik Gauting GmbH Coordinator of this site? Confirm its status | Gauting | Germany | Recruiting |
| Universitaetsklinikum des Saarlandes AöR Coordinator of this site? Confirm its status | Homburg | Germany | Recruiting |
| Sana Klinikum Offenbach GmbH Coordinator of this site? Confirm its status | Offenbach Am Main | Germany | Recruiting |
| Pius Hospital Oldenburg Coordinator of this site? Confirm its status | Oldenburg | Germany | Recruiting |
| Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH Coordinator of this site? Confirm its status | Regensburg | Germany | Recruiting |
| Klinikum Der Landeshauptstadt Stuttgart gKAöR Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
| Klinikum Wuerzburg Mitte gGmbH Coordinator of this site? Confirm its status | Wuerzburg | Germany | Recruiting |
| Complexo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Recruiting |
| Hospital Universitario Clínico San Cecilio Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida Coordinator of this site? Confirm its status | Lleida | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Son Llatzer Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Salut Sant Joan de Reus Coordinator of this site? Confirm its status | Reus | Spain | Recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Recruiting |
| Hospital Universitario Nuestra Señora de Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Recruiting |
| Hospital Universitario San Juan de Alicante Coordinator of this site? Confirm its status | Sant Joan d'Alacant | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre Hospitalier d'Avignon Coordinator of this site? Confirm its status | Avignon | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Centre Francois Baclesse Coordinator of this site? Confirm its status | Caen Cedex 5 | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Not yet recruiting |
| Hospital Foch Coordinator of this site? Confirm its status | Suresnes | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| Thoracic General Hospital of Athens "I Sotiria" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| Henry Dunant Hospital Center Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Maroussi | Greece | Recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Recruiting |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong | Recruiting |
| Prince of Wales Hosp Coordinator of this site? Confirm its status | Shatin | Hong Kong | Recruiting |
| Cork University Hospital Coordinator of this site? Confirm its status | Cork | Ireland | Recruiting |
| St James's Hospital Coordinator of this site? Confirm its status | Dublin 8 | Ireland | Recruiting |
| University Hospital Galway Coordinator of this site? Confirm its status | Galway | Ireland | Recruiting |
| Cliniche Gavazzeni S.p.A. Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Fondazione IRCCS - Istituto Nazionale dei Tumori Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
| Fondazione IRCCS San Gerardo dei Tintori Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Hospital Santa Maria Della Misericordia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| Ospedale P. Pederzoli Casa di Cura Privata S.p.A. Coordinator of this site? Confirm its status | Peschiera del Garda | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| I.F.O. Istituti Fisioterapici Ospitalieri Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Gifu University Hospital Coordinator of this site? Confirm its status | Gifu | Japan | Recruiting |
| Kobe University Hospital Coordinator of this site? Confirm its status | Hyōgo | Japan | Recruiting |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Yeungnam University Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Recruiting |
| Ajou University Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Recruiting |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Jeollanam-do | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Zuyderland Medisch Centrum Stichting Coordinator of this site? Confirm its status | Geleen | Netherlands | Not yet recruiting |
| Jeroen Bosch Ziekenhuis Stichting Coordinator of this site? Confirm its status | 'S-Hertogenbosch | Netherlands | Not yet recruiting |
| Centrum Pulmonologii i Torakochirurgii w Bystrej Coordinator of this site? Confirm its status | Bystra | Poland | Recruiting |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Recruiting |
| Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach Coordinator of this site? Confirm its status | Kielce | Poland | Recruiting |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Recruiting |
| National Institute Of Tuberculosis And Lung Diseases Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Hospital Cuf Tejo S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Champalimaud Clinical Centre Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Loures-Odivelas EPE Coordinator of this site? Confirm its status | Loures | Portugal | Recruiting |
| Unidade Local de Saude de Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Recruiting |
| Piedmont Cancer Institute, PC Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Community Cancer Institute (CCI) Coordinator of this site? Confirm its status | Clovis | United States | Recruiting |
| San Juan Oncology Associates Coordinator of this site? Confirm its status | Farmington | United States | Recruiting |
| Profound Research, LLC Coordinator of this site? Confirm its status | Farmington Hills | United States | Recruiting |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Cancer Care Specialists Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.