Health Trials

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)

ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Divarasib

    Drug

    Divarasib will be administered orally as per the schedule specified in the respective arm.

  • Pembrolizumab

    Drug

    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).

  • Nivolumab

    Drug

    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).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: DivarasibExperimental treatment 1 intervention
Group B: Control: Pembrolizumab or Nivolumab or ObservationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

Overall Survival (OS)

Time frame
From date of randomization to death from any cause (up to approximately 8 years)
2

DFS Rates at 2 and 3 Years, as Assessed by the Investigator

Time frame
At Year 2 and Year 3
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov
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