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Clinical Trials List

Protocol NumberRMC-6236-301
NCT Number(ClinicalTrials.gov Identfier)NCT06881784
Active

2025-05-01 - 2030-12-01

Phase III

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

NSCLC (Non-small Cell Lung Cancer)

Objectives

Compare the therapeutic effects of RMC-6236 and Docetaxel in the RAS (G12X-C) population.

Test Drug

Tablets Infusion

Active Ingredient

RMC-6236
DOCETAXEL

Dosage Form

110
27C

Dosage

20 mg
160mg/8ml

Endpoints

• PFS is defined as the time elapsed from randomization to disease progression or death from any cause (whichever occurs first). Disease progression is assessed by the trial administrator according to RECIST v1.1.

Inclution Criteria

Inclusion Criteria:

At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
Measurable disease per RECIST v1.1.
Adequate organ function (bone marrow, liver, kidney, coagulation).
One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
Able to take oral medications.

Exclusion Criteria

Exclusion Criteria:

Prior therapy with direct RAS-targeted therapy or docetaxel.
Untreated central nervous system (CNS) metastases.
Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).
Ongoing anticancer therapy.
Pregnant or breastfeeding.

The Estimated Number of Participants

  • Taiwan

    13 participants

  • Global

    420 participants