Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
Purpose
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.
Conditions
- NSCLC
- Non-small Cell Lung Cancer
- Non-Small Cell Lung Cancer NSCLC
- Non-Squamous Non Small Cell Lung Cancer
- Lung Cancer (NSCLC)
- Metastatic NSCLC - Non-Small Cell Lung Cancer
- Metastatic Non-Squamous Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
- Masking Description
- Chemotherapy and pembrolizumab administration will be open label. This study is double-blind with respect to zoldonrasib versus placebo. Treatment assignments will remain blinded to Investigator, study center staff, patient, Sponsor and study vendors.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A: zoldonrasib + pembrolizumab + chemotherapy doublet |
study drug in combination with pembrolizumab and platinum-based chemotherapy doublet |
|
|
Placebo Comparator Arm B: placebo + pembrolizumab + chemotherapy doublet |
placebo in combination with pembrolizumab and platinum-based chemotherapy doublet |
|
Recruiting Locations
Plantation, Florida 33322
More Details
- Status
- Recruiting
- Sponsor
- Revolution Medicines, Inc.
Detailed Description
This is a Phase 3, global, randomized, double-blind study designed to evaluate whether treatment with zoldonrasib in combination with pembrolizumab and platinum-based chemotherapy doublet will improve progression-free survival compared to placebo in combination with pembrolizumab and platinum-based chemotherapy doublet when given to patients with previously untreated, 1L metastatic RAS G12D-mutated, non-squamous non-small cell lung cancer (NSCLC). Patients will be randomized to one of two arms: zoldonrasib + pembrolizumab + platinum-based chemotherapy doublet (Arm A) or placebo + pembrolizumab + platinum-based chemotherapy doublet (Arm B).