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A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

ConditionsNon-Small Cell Lung CancerKRAS G12C Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically or cytologically confirmed diagnosis of advanced or metastatic non squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy

Measurable disease, as defined by RECIST v1.1

No prior systemic treatment for advanced or metastatic NSCLC

Disqualifiers

Known concomitant second oncogenic driver with available targeted treatment

Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases

Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to randomization

History of leptomeningeal disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Divarasib

    Drug

    Divarasib will be administered orally QD

  • Pembrolizumab

    Drug

    Pembrolizumab will be administered via IV infusion Q3W

  • Pemetrexed

    Drug

    Pemetrexed will be administered via IV infusion Q3W

  • Carboplatin

    Drug

    Carboplatin will be administered via IV infusion Q3W

  • Cisplatin

    Drug

    Cisplatin will be administered via IV infusion Q3W

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Divarasib + PembrolizumabExperimental treatment 2 interventions
Group B: Pembrolizumab + Pemetrexed + Carboplatin or CisplatinActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival (PFS)

PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by blinded independent central review (BICR) according to RECIST v1.1, or death from any cause (whichever occurs first)

Time frame
Up to approximately 5 years
2

Overall Survival (OS)

OS is defined as the time from randomization to death from any cause

Time frame
Up to approximately 5 years

Secondary outcomes

1

Objective Response

Objective response is defined as complete response (CR) or partial response (PR) on two consecutive occasions \>=4 weeks apart, as determined by BICR according to RECIST v1.1

Time frame
Up to approximately 5 years
2

Change from Baseline on the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module (EORTC QLQ-LC13) Cough Scale

Time frame
Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
3

Change from Baseline on the EORTC Quality of Life Questionnaire (QLQ-C30) Dyspnea Item and Physical Functioning Scale

Time frame
Baseline up to Cycle 5 Day 1 (each cycle is 21 days)
4

Duration of Response (DOR)

DOR is defined as the time from the first occurrence of a documented objective response to disease progression, as determined by BICR according to RECIST v1.1, or death from any cause (whichever occurs first)

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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

Hoffmann-La Roche

Lead sponsor

Chugai Pharmaceutical

Collaborator

Source ClinicalTrials.gov
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