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

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

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

Conditions3

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