Non-small Cell Lung CancerPhase 3KRASCENDO 3NCT07541170
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 3 study testing Divarasib, Pembrolizumab and Nivolumab in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 46 sites in 14 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Divarasib, Pembrolizumab and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 46 sitesin 14 countries
- Study dates
- 6 Oct 2026to 31 Mar 2035
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who achieve pCR following neoadjuvant 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
- Active or history of autoimmune disease or immune deficiency
- Significant cardiovascular disease
Trial locations and contacts
46 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
46 sites in 14 countries
South Korea9 sites, 9 recruiting
- Recruiting
Pusan National University Hospital
Busan, 602-739
- Recruiting
Yeungnam University Medical Center
Daegu, 42415
- Recruiting
Chungnam National University Hospital
Daejeon, 35015
- Recruiting
Ajou University Medical Center
Gyeonggi-do, 16499
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
United States6 sites, 6 recruiting
- Recruiting
Piedmont Cancer Institute, PC
Atlanta, Georgia, 30318
- Recruiting
Community Cancer Institute (CCI)
Clovis, California, 93611
- Recruiting
San Juan Oncology Associates
Farmington, New Mexico, 87401
- Recruiting
Profound Research, LLC
Farmington Hills, Michigan, 48334
- Recruiting
Renown Regional Medical Center
Reno, Nevada, 89502
- Recruiting
Cancer Care Specialists
Reno, Nevada, 89511
Argentina6 sites, 6 recruiting
- Recruiting
Instituto Argentino de Diagnóstico y Tratamiento- IADT
Capital Federal, C1122AAL
- Recruiting
Hospital Britanico
Ciudad Autonoma Buenos Aires, C1280AEB
- Recruiting
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
- Recruiting
Clinica Adventista Belgrano
Ciudad Autonoma Buenos Aires, C1430EGF
- Recruiting
Hospital Privado De Comunidad
Mar del Plata, B7602CBM
- Recruiting
Sanatorio de la Mujer
Rosario, Santa Fe Province, S2000ORE
Brazil5 sites, 5 recruiting
- Recruiting
Cenantron - Centro Avancado de Tratamento Oncologico
Belo Horizonte, Minas Gerais, 30130-090
- Recruiting
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-001
- Recruiting
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
- Recruiting
Beneficencia Portuguesa de Sao Paulo
São Paulo, 01321-00
Spain5 sites, 5 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, 15006
- Recruiting
Hospital General Univ. de Alicante
Alicante, 03010
- Recruiting
Hospital de Basurto
Bilbao, Vizcaya, 48013
- Recruiting
Hospital Universitario San Cecilio
Granada, 18016
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Poland3 sites, 3 recruiting
- Recruiting
Centrum Pulmonologii i Torakochirurgii
Bystra, 43-360
- Recruiting
Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz
Gda?sk, 80-214
- Recruiting
?wi?tokrzyskie Centrum Onkologii Samodzielny Publiczny Zak?ad Opieki Zdrowotnej w Kielcach;Klinika Onkologii Klinicznej
Kielce, 25-734
Colombia2 sites, 2 recruiting
- Recruiting
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., 110131
- Recruiting
Clinica ASTORGA
Medellín, 50010
Greece2 sites, 2 recruiting
- Recruiting
Attikon University General Hospital
Athens, 124 61
- Recruiting
Athens Medical Center
Marousi, 151 25
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
- Recruiting
Prince of Wales Hosp
Shatin
Japan2 sites, 2 recruiting
- Recruiting
Gifu University Hospital
Gifu, 501-1194
- Recruiting
Kobe University Hospital
Hyōgo, 650-0017
Canada1 site, 1 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, 510030
Italy1 site, 1 recruiting
- Recruiting
Ospedale P. Pederzoli Casa di cura Privata
Peschiera Del Garda (VR), Veneto, 37019
Portugal1 site, 1 recruiting
- Recruiting
Centro Clinico Champalimaud
Lisbon, 1400-038
About this study
Official title: 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
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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Divarasib, Pembrolizumab, Nivolumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DivarasibDrug
Also called RO743584; GDC-6036
Divarasib will be administered orally as per the schedule specified in the respective arm.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days).
NivolumabDrug
Also called Opdivo
Nivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days).
| Study group | Role | What they receive |
|---|---|---|
| Divarasib | Experimental | Participants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days). Receives: Drug: Divarasib |
| Control: Pembrolizumab or Nivolumab or Observation | Active comparator | Participants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation. Receives: Drug: Pembrolizumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free Survival (DFS), as Determined by the Investigator
Measured: From randomization to disease recurrence or death from any cause (Up to approximately 5 years)
Secondary outcomes (3)
Overall Survival (OS)
Measured: From date of randomization to death from any cause (up to approximately 8 years)
DFS Rates at 2 and 3 Years, as Assessed by the Investigator
Measured: At Year 2 and Year 3
Number of Participants With Adverse Events (AEs)
Measured: From randomization to 60 days after the end of study treatment (up to approximately 8 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start6 Oct 2026
- Primary completion31 Jan 2032 (estimated)
- Study completion31 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541170
- Sponsor's protocol ID
- BO45885
- Other IDs
- 2025-524263-21-00, 2025
- Acronym
- KRASCENDO 3
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07541170
- Acronym / sponsor ID
- KRASCENDO 3 / BO45885
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 31 Jan 2032 (estimated)
- Study completion
- 31 Mar 2035 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divarasib | Experimental | Drug: DivarasibParticipants will receive divarasib, orally (PO), once daily (QD) for up to 52 cycles (1 cycle = 21 days). |
| Control: Pembrolizumab or Nivolumab or Observation | Active comparator | Drug: Pembrolizumab, Drug: NivolumabParticipants will receive either pembrolizumab, nivolumab, or undergo observation, depending on the treatment received prior to surgery. No study treatment will be given to participants who will undergo observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Participants who achieve pCR following neoadjuvant 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
- Active or history of autoimmune disease or immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DivarasibAlso: RO743584; GDC-6036Divarasib will be administered orally as per the schedule specified in the respective arm. | Drug | Divarasib |
| PembrolizumabAlso: KeytrudaPembrolizumab will be administered as either a 200 mg intravenous (IV) infusion, every 3 weeks (Q3W) or 395 mg subcutaneous (SC) injection Q3W, for up to 13 cycles (1 cycle = 21 days). | Drug | Control: Pembrolizumab or Nivolumab or Observation |
| NivolumabAlso: OpdivoNivolumab will be administered as either a 480 mg IV infusion, every 4 weeks (Q4W) or 1200 mg SC injection Q4W, for up to 13 cycles (1 cycle = 28 days). | Drug | Control: Pembrolizumab or Nivolumab or Observation |
Primary outcome
Disease-free Survival (DFS), as Determined by the Investigator
Time frame: From randomization to disease recurrence or death from any cause (Up to approximately 5 years)
3 secondary outcomes
Overall Survival (OS)
Time frame: From date of randomization to death from any cause (up to approximately 8 years)
DFS Rates at 2 and 3 Years, as Assessed by the Investigator
Time frame: At Year 2 and Year 3
Number of Participants With Adverse Events (AEs)
Time frame: From randomization to 60 days after the end of study treatment (up to approximately 8 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
46 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divarasib, Pembrolizumab and Nivolumab in people with Non-small Cell Lung Cancer, run by Hoffmann-La Roche at 46 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in South Korea, United States, Argentina, Brazil, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free Survival (DFS), as Determined by the Investigator (time frame: From randomization to disease recurrence or death from any cause (Up to approximately 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.