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Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT07463677 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2026-03-11

No results posted yet for this study

Summary

This study investigated the efficacy and safety of Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Conditions

  • Lung Cancer (NSCLC)

Interventions

DRUG

Tunlametinib + Cetuximab β

Study Population: Previously treated subjects with KRAS (non-G12C) mutation-positive, unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) (n=6). Treatment Regimen: Tunlametinib + Cetuximab β Injection Starting Dose Cohort: Tunlametinib: 9 mg per dose, administered orally twice daily (BID). Cetuximab β Injection: 500 mg/m² per dose (calculated based on body surface area), administered intravenously once every two weeks. Cycle Definition: Every 4 weeks constitutes one treatment cycle. Second Dose Cohort: Tunlametinib: 12 mg or 6 mg per dose, administered orally twice daily (BID). Rationale: This cohort aims to identify the optimal dose. From the perspective of maximizing subject benefit, the dose may be either reduced or increased. Therefore, the dose is subject to dynamic adjustment based on ongoing clinical trial observations, rather than following a traditional dose-escalation design. Investigators will continuously review safety data from subjects a

DRUG

Tunlametinib + Fulzerasib

Study Population: Previously treated subjects with KRAS G12C mutation-positive, unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) (n=6). Treatment Regimen: Tunlametinib + Fluorescein Starting Dose Cohort: Tunlametinib: 9 mg per dose, administered orally twice daily (BID). Fluorescein: 600 mg per dose, administered orally twice daily (BID). Cycle Definition: Every 4 weeks constitutes one treatment cycle. Second Dose Cohort: Tunlametinib: 12 mg or 6 mg per dose, administered orally twice daily (BID). Fluorescein: 600 mg per dose, administered orally twice daily (BID). Cycle Definition: Every 4 weeks constitutes one treatment cycle.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2028-05-31
Completion
2029-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463677 on ClinicalTrials.gov