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

Recruiting now · Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT06709859

Run by

Shandong Public Health Clinical Center

People needed

30

Starts

2025-05-01

Expected to finish

2027-12-31

Last updated by the study team

2025-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shandong Public Health Clinical Center — Jinan, Shangdong, China (enrolling)

Full record on ClinicalTrials.gov

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