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Clinical Trials in China / NCT06709859
Recruiting Phase 2

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

NCT06709859 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Public Health Clinical Center
Phase
Phase 2
Started
2025-05-01
Last updated
2025-07-17

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

Afatinib plus chemotherapy as conversion treatment →

Afatinib plus chemotherapy as conversion treatment: Patients with unresectable EGFR sensitive mutation-positive stage III NSCLC will receive 3-4 cycles of afatinib plus chemotherapy as the conversion treatment, and then surgery will be provided for patients who are suitable for primary tumor resection.

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of unresectable Stage III non-small cell lung cancer as judged by the investigator. * Tissue or blood samples tested and confirmed to be positive for EGFR sensitive mutation * ECOG Performance Status of 0-1 * At least one measurable lesion according to RECIST 1.1 * Adequate organ and marrow function Exclusion Criteria: * Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine 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 absorption of test drugs (such as Crohn's disease, ulcerative colitis, absorption disorders, or diarrhea of any cause ≥ Grade 2 CTCAE) according to the investigator's assessment

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shandong Public Health Clinical Center Jinan Shangdong Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06709859 on ClinicalTrials.gov ↗ ← All trials in China