Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC

Last updated: July 14, 2025
Sponsor: Shandong Public Health Clinical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Afatinib plus chemotherapy as conversion treatment

Clinical Study ID

NCT06709859
GWLCZXEC2024-56-2
  • Ages > 18
  • All Genders

Study Summary

This is a phase II, single-arm study to evaluate the efficacy and safety of Afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pathologically or cytologically confirmed diagnosis of unresectable Stage IIInon-small cell lung cancer as judged by the investigator.

  • Tissue or blood samples tested and confirmed to be positive for EGFR sensitivemutation

  • ECOG Performance Status of 0-1

  • At least one measurable lesion according to RECIST 1.1

  • Adequate organ and marrow function

Exclusion

Exclusion Criteria:

  • Histologically or cytologically confirmed combined SCLC and NSCLC, large cellneuroendocrine carcinoma, and sarcoma-like carcinoma

  • The presence of malignant pleural effusion

  • Prior systemic anti-cancer therapy for non-small cell lung cancer

  • Prior local radiotherapy for NSCLC

  • Patients with uncontrolled gastrointestinal diseases that may affect the absorptionof test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, ordiarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Afatinib plus chemotherapy as conversion treatment
Phase: 2
Study Start date:
May 01, 2025
Estimated Completion Date:
December 31, 2027

Study Description

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of afatinib plus chemotherapy as conversion treatment in patients with unresectable EGFR sensitive mutation-positive stage III non-small cell lung cancer.

The primary endpoint was the rate of NSCLC converting to resectable tumors. The secondary endpoints included R0 resection rate, major pathological response (MPR) rate, pathological complete response (pCR) rate, tumor downstaging rate, objective response rate (ORR), disease control rate (DCR), 1-year event-free survival (EFS) rate, EFS and overall survival (OS).

Connect with a study center

  • Shandong Public Health Clinical Center

    Jinan, shangdong 250000
    China

    Active - Recruiting

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