NCT07463677

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

A Study Protocol for Evaluating the Efficacy and Safety of Tunlametinib Combination Therapy in KRAS-Mutated Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-05-31
• Completion: 2029-03-31
• First posted: 2026-03-11
• Last updated: 2026-03-11