Clinical trial · Interventional
Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib as First Line Treatment in Metastatic Non-squamous RAS G12D-Mutated NSCLC
A Randomized, Double-blind, Phase 3 Study of Pembrolizumab + Pemetrexed + Platinum Chemotherapy With or Without Zoldonrasib (RMC-9805) as First Line Treatment in Patients With Metastatic Non-squamous RAS G12D-Mutated Non-small Cell Lung Cancer (RASolve 308)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (NSCLC) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Metastatic Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic NSCLC - Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non-Small Cell Lung Cancer NSCLC | — | UNRESOLVED | — |
| Non-Squamous Non Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pembrolizumab | Drug | Pembrolizumab | ALIAS |
| pemetrexed + cisplatin /carboplatin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
| zoldonrasib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: zoldonrasib + pembrolizumab + chemotherapy doublet
- description
- study drug in combination with pembrolizumab and platinum-based chemotherapy doublet
- interventionNames
- Drug: zoldonrasib
- Drug: pembrolizumab
- Drug: pemetrexed + cisplatin /carboplatin
- type
- PLACEBO_COMPARATOR
- label
- Arm B: placebo + pembrolizumab + chemotherapy doublet
- description
- placebo in combination with pembrolizumab and platinum-based chemotherapy doublet
- interventionNames
- Drug: Placebo
- Drug: pembrolizumab
- Drug: pemetrexed + cisplatin /carboplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available