A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)

Study Identifier:
RMC-LUNG-101B
CT.gov Identifier:
NCT06162221
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-509571-16-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other.

The first four subprotocols include the following:

Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805

To evaluate the safety and tolerability of RMC6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated solid tumors To define the RP2DS for RMC-6291 in combination with pembrolizumab, with or without RMC-6236, with or without chemotherapy, in patients with advanced RAS G12C-mutated NSCLC

To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Non-Small Cell Lung Cancer
  • Gene Mutations
  • Solid Tumor
  • Other Lung Cancer
  • Unspecified Cancer
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Subprotocol A: KRAS G12C-Mutated Solid Tumors
    • Read More
  • Drug: Drug: RMC-6236
  • Drug: Drug: Pembrolizumab
  • Drug: Drug: Cisplatin
  • Drug: Drug: Carboplatin
  • Drug: Drug: Pemetrexed
  • Drug: Experimental: Subprotocol B: RAS-mutated NSCLC
  • Drug: Experimental: Subprotocol C: RAS G12D-mutated NSCLC
  • Drug: Drug: RMC-9805
  • Drug: Experimental: Subprotocol D: RAS G12D-mutated NSCLC
  • Drug: Subprotocol D is a Phase 2, Open-label, Multicenter Study of Zoldonrasib (RMC-9805) in Previously Treated Patients with RAS G12D-Mutant Non-Small Cell Lung Cancer (NSCLC)
  • Drug: Subprotocols A, B, and C consist of two parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion. Subprotocol D consists of only one part.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • ≥ 18 years of age
    • ECOG PS is 0 to 1
    • Adequate organ function as outlined by the study
    • Received prior standard therapy appropriate for tumor type and stage
    • Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)
    • Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)
    • Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)
    Exclusion criteria
    • All Patients:
    • Primary central nervous system (CNS) tumors
    • Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs
    • Major surgery < 28 days of first dose
    • Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids
    • Participants that have primary brain and spinal cord tumor.
    • Participants that have any other medical condition that may interfere with the study drugs
    • Participants that have previously taken targeted therapy for KRAS mutation.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Bernard Doger de Speville
    Status
    Recruiting
    Condition(s) Treated at Site
    Non-Small Cell Lung Cancer
    Gene Mutations
    Solid Tumor
    Other Lung Cancer
    Unspecified Cancer