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RECRUITING
NCT07622706
PHASE2

Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma. The goal of this study was to evaluate the efficacy of firmonertinib neoadjuvant in patients with resectable stage II-IIIB EGFR-mutated non-small cell lung cancer (NSCLC) by major pathologic response (MPR).

Official title: An Open-label, Single-arm, Phase II Clinical Study of Firmonertinib in Perioperative Treatment of Resectable Stage II-IIIB EGFR-mutated Lung Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-03

Completion Date

2029-12-30

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Firmonertinib 80mg qd oral for 8 weeks.

Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

DRUG

Firmonertinib 160mg qd oral for 8 weeks.

Participations will receive the drug treatments preoperatively: Firmonertinib 160mg qd oral for 8 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

DRUG

Firmonertinib 80mg qd oral for 16 weeks.

Participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral for 16 weeks. Radical tumor resection will be completed 3-4 weeks after the end of drug treatment.

PROCEDURE

Radical resection

Radical resection of the tumor will be performed within 3-4 weeks after the end of treatment.

DRUG

firmonertinib adjuvant therapy

After surgery, participations will receive the drug treatments preoperatively: Firmonertinib 80mg qd oral as adjuvant therapy for 3 years. The investigator may decide whether to add chemotherapy or to change other adjuvant treatment modalities.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, China