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)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
400 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
This trial is looking for people with non-small cell lung cancer that has been surgically removed. Participants will be given either a new treatment called divarasib or an immunotherapy chosen by their doctor.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with non-small cell lung cancer.
I have had my cancer completely removed by surgery.
I received neoadjuvant treatment with pembrolizumab or nivolumab and chemotherapy.
I have a KRAS G12C mutation.
I am within 12 weeks of my surgery.
I have an ECOG performance status of 0 or 1.
I have no evidence of disease recurrence.
You may not be able to join if
I achieved a complete response after my previous treatment.
I have received a KRAS inhibitor or other anti-cancer treatment not specified in this study.
I have had radiation for lung cancer, except for localized treatment before my surgery.
I have unresolved serious immune-related side effects from previous treatments.
I have an active autoimmune disease or immune deficiency.
I have significant cardiovascular disease.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 pathologi…
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.
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 neoadjuva…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Contacts
Reference Study ID Number: BO45885 https://forpatients.roche.com/ No attachments to email below.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
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