Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 versus Docetaxel in Patients with Previously Treated Unresectable or Metastatic NSCLC Harboring RAS Mutations

Cancer Categories

Lung

Karmanos Trial ID

2025-028

NCT ID

NCT06881784

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Tarik
Hadid, M.D., MPH, MS, FACP
Oncology - Medical View Profile

Objective:

Primary:

In the RAS (G12X-C) population, i.e., RAS G12X excluding G12C:

To compare the treatment effect of RMC-6236 versus docetaxel on:
- PFS (per Investigator)
- OS

Key Secondary

In the RAS (MUT) population:

To compare the treatment effect of RMC-6236 versus docetaxel on:
- PFS (per Investigator)
- OS

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on objective response (per Investigator)

Other Secondary

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on:
- PFS (per BICR)
- Objective response (per BICR)

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on:
- DOR (per Investigator and per BICR)
- TTR (per Investigator and per BICR)

In the RAS (G12X-C) and RAS (MUT) populations:

To compare the treatment effect of RMC-6236 versus docetaxel on QoLs using EORTC QLQ-LC13 and EORTC QLQ-C30

In the RAS (G12X-C) and RAS (MUT) population:

To compare safety and tolerability of RMC-6236 versus docetaxel

In the RAS (MUT) population:

To characterize the PK of RMC-6236

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Eligibility

Inclusion Criteria:

At least 18 years old and has provided informed consent.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Histologically 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:

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.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices