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NOT YET RECRUITING
NCT07878871
PHASE2

Firmonertinib Plus Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Cancer: A Phase II Study

Sponsor: Hunan Province Tumor Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, multicenter Phase II clinical study. It aims to evaluate the efficacy and safety of Firmonertinib combined with chemotherapy in patients with unresectable Stage III lung adenocarcinoma harboring EGFR PACC mutations. Participants will receive Firmonertinib combined with standard chemotherapy. The primary objective is to assess the objective response rate (ORR). This study will provide important evidence for a potential new treatment option for this specific patient population.

Official title: Firmonertinib Combined With Chemotherapy for Unresectable EGFR PACC-Mutant Stage III Lung Adenocarcinoma: A Prospective, Single-Arm, Multicenter Phase II Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2026-11

Completion Date

2031-12

Last Updated

2026-10-16

Healthy Volunteers

No

Interventions

DRUG

Firmonertinib

Firmonertinib mesylate tablets, 160 mg, oral administration, once daily. Administered during induction and consolidation phases.

DRUG

Platinum-based chemotherapy

Pemetrexed (500 mg/m²) combined with Carboplatin or Cisplatin. Administered during the 3-4 cycles of induction therapy

Locations (1)

Hunan Cancer Hospital

Changsha, Hunan, China