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Clinical Trials List

Protocol NumberRMC-6236-301

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

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

IQVIA Holdings, Inc.
Trial scale

Multi-Regional Multi-Center
Update

2026/03/01

Investigators and Locations

Principal Investigator Chien-Chung Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 柯皓文無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Jen Yang

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Locally advanced or metastatic RAS-mutant non–small cell lung cancer (NSCLC)

Objectives

Compare the therapeutic efficacy of RMC-6236 versus docetaxel in patients with RAS (G12X-C) mutant non–small cell lung cancer.

Test Drug

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion

Active Ingredient

RMC-6236
DOCETAXEL

Dosage Form

110
27C

Dosage

20 mg
160mg/8ml

Endpoints

Progression-free survival (PFS) is defined as the time from randomization to the first documented disease progression or death from any cause, whichever occurs first. Disease progression is assessed by the investigator according to RECIST v1.1 criteria.

Inclution Criteria

Aged 18 years or older and has provided informed consent.
ECOG performance status of 0 or 1.
Histologically confirmed locally advanced or metastatic non–small cell lung cancer (NSCLC) that is not amenable to curative surgery or radiotherapy.
Measurable disease per RECIST v1.1 criteria.
Adequate organ function (bone marrow, hepatic, renal, and coagulation).
One or two prior lines of therapy, including anti–PD-1/PD-(L)1 agents and platinum-based chemotherapy.
Documented RAS mutation status, defined as a nonsynonymous mutation in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
Ability to take oral medications.
For the complete list of inclusion criteria, please refer to the study protocol.

Exclusion Criteria

Prior treatment with RAS-directed therapy or docetaxel.

Untreated central nervous system (CNS) metastases.

Clinically significant comorbidities, including severe cardiovascular disease, pulmonary disease, or gastrointestinal impairment.

Ongoing anticancer therapy.

Pregnant or breastfeeding.

For the complete list of exclusion criteria, please refer to the study protocol.

The Estimated Number of Participants

Taiwan

13 participants
Global

420 participants