NCT07001995

Limertinib Plus Carboplatin and Etoposide for EGFR-mutant NSCLC With SCLC Transformation After EGFR-TKI Progression

A Single-center, Single-arm Phase II Study of Limertinib Plus Carboplatin and Etoposide in EGFR-mutant NSCLC Patients With SCLC Transformation After EGFR-TKI Progression

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This single-center, prospective study and aims to evaluate the efficacy and safety of limertinib combined with etoposide and carboplatin in EGFR-mutant NSCLC patients who develop small-cell lung cancer transformation following progression on EGFR-TKI therapy.

Detailed description

This is a single-center, prospective interventional Phase II study designed to assess the efficacy, safety and mechanism of resistance to limertinib combined with carboplatin and etoposide in EGFR-mutant NSCLC patients who have histologically confirmed small-cell transformation after progression on EGFR-TKI therapy. Thirty patients will receive Limertinib orally once daily (80 mg) plus carboplatin (AUC 5-6, day 1) and etoposide (100 mg/m², days 1-3) every 21 days until disease progression or unacceptable toxicity. Radiographic tumor evaluation will be conducted every 6 weeks per RECIST v1.1. Tumor tissue and blood specimens will be collected at baseline and upon disease progression for next-generation sequencing to elucidate the molecular mechanisms underlying histological transformation.

Conditions

• Small Cell Lung Cancer
• Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer NSCLC

Interventions

Type	Name	Description
DRUG	limertinib	limertinib 80 mg
DRUG	etoposide and carboplatin	etoposide 100 mg/m² IV D1-3 + carboplatin AUC 5-6 IV

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2025-06-03
• Last updated: 2026-03-16

Locations

1 site across 1 country: China