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Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC

ConditionsNSCLCNon-small Cell Lung CancerNon-Small Cell Lung Cancer NSCLCNon-Squamous Non Small Cell Lung CancerLung Cancer (NSCLC)Metastatic NSCLC - Non-Small Cell Lung CancerMetastatic Non-Squamous Non-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with pembrolizumab and platinum-based chemotherapy doublet compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old and has provided informed consent.

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

Histologically or cytologically confirmed, previously untreated metastatic non-squamous NSCLC.

Known PD-L1 status

Disqualifiers

Prior treatment with systemic anticancer therapy in metastatic setting for NSCLC.

Prior systemic therapy with any RAS-directed therapy.

Untreated (symptomatic or asymptomatic) central nervous system metastatic disease.

Any conditions that may affect the ability to take or absorb study drug.

Trial design

Design model

Parallel

Treatments tested in this trial

  • zoldonrasib

    Drug

    oral tablets

  • Placebo

    Drug

    oral tablets

  • pembrolizumab

    Drug

    IV infusion or Subcutaneous injection

  • pemetrexed + cisplatin /carboplatin

    Drug

    IV infusion of either pemetrexed + cisplatin or pemetrexed + carboplatin

Treatment groups

430 Participants
are divided into 2 treatment groups
Group A: Arm A: zoldonrasib + pembrolizumab + chemotherapy doubletExperimental treatment 3 interventions
Group B: Arm B: placebo + pembrolizumab + chemotherapy doubletPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is assessed per response evaluation criteria in solid tumors (RECIST) v1.1 by blinded independent central review (BICR).

Time frame
Up to approximately 5 years

Secondary outcomes

1

Overall survival (OS)

OS is defined as the time from randomization until death from any cause.

Time frame
Up to approximately 5 years
2

Objective response rate (ORR)

Objective response is defined as partial response (PR) or complete response (CR) as assessed per RECIST v1.1 by BICR.

Time frame
Up to approximately 5 years
3

Duration of response (DOR)

DOR is defined as time from first evidence of objective response (PR or CR) to disease progression or death due to any cause, whichever occurs first. Response and progression are per RECIST v1.1, as assessed by BICR.

Time frame
Up to approximately 5 years
4

Incidence of adverse events (AEs)

Percentage of patients with AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5

Time frame
Up to approximately 5 years

Other outcomes

Sponsors and contacts

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

Revolution Medicines, Inc.

Lead sponsor

Source ClinicalTrials.gov
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