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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

NCT07777822

RecruitingPhase 3

Sponsor: Revolution Medicines, Inc.

Conditions: NSCLC, Non-small Cell Lung Cancer, Non-Small Cell Lung Cancer NSCLC, Non-Squamous Non Small Cell Lung Cancer, Lung Cancer (NSCLC)

Interventions: zoldonrasib, Placebo, pembrolizumab, pemetrexed + cisplatin /carboplatin

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* Documented RAS G12D mutation status.
* Measurable disease per RECIST v1.1.
* Adequate organ function (bone marrow, liver, kidney, coagulation, thyroid).
* Able to take oral medications.

Exclusion Criteria:

* 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.
* Major surgery on or within 28 days prior to randomization.
* Patient is unable or unwilling to comply with protocol-required study visits or procedures.
* Additional inclusion and exclusion criteria may apply

Locations (1)

Plantation, Florida, United States