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Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC

ConditionsNon-Small Cell Lung Cancer, NSCLCKRAS, NRAS, HRAS-mutated NSCLCKRAS G12C-mutated Solid Tumors, Lung CancerLung Cancer Stage IV, Advanced Solid Tumor, CancerRAS G12D-mutated NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRevolution Medicines, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • RMC-6291

    Drug

    Oral tablet

  • RMC-6236

    Drug

    Oral tablet

  • Pembrolizumab

    Drug

    IV Infusion

  • Cisplatin

    Drug

    IV Infusion

  • Carboplatin

    Drug

    IV Infusion

  • Pemetrexed

    Drug

    IV infusion

  • RMC-9805

    Drug

    Oral Tablet

Treatment groups

616 Participants
are divided into 4 treatment groups
Group A: Subprotocol A: KRAS G12C-Mutated Solid TumorsExperimental treatment 6 interventions
Group B: Subprotocol B: RAS-mutated NSCLCExperimental treatment 5 interventions
Group C: Subprotocol C: RAS G12D-mutated NSCLCExperimental treatment 6 interventions
Group D: Subprotocol D: RAS G12D-mutated NSCLCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs

Time frame
Up to 5 years
2

Dose limiting toxicities

Number of participants with dose limiting toxicities

Time frame
21 days

Secondary outcomes

1

Drug concentrations over time

Observed blood concentration of each drug as applicable per subprotocol

Time frame
Up to 21 weeks
2

Cmax

Maximum observed blood concentration of each drug as applicable per subprotocol

Time frame
Up to 21 weeks
3

Tmax

Time to reach maximum blood concentration of each drug as applicable per subprotocol

Time frame
Up to 21 weeks
4

AUC

Area under the concentration-time curve of each drug as applicable per subprotocol

Time frame
Up to 21 weeks

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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