Afatinib plus chemotherapy to convert unresectable EGFR‑mutant stage III NSCLC into resectable disease.
A Phase II Trial to Evaluate the Efficacy and Safety of Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III Non-small Cell Lung Cancer
This trial will see if afatinib combined with chemotherapy can shrink unresectable, EGFR‑sensitive mutation positive stage III non‑small cell lung cancer enough to allow surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shandong Public Health Clinical Center Government |
| Drugs / interventions | Afatinib, chemotherapy |
| Locations | 1 site (Jinan, Shangdong) |
| Trial ID | NCT06709859 on ClinicalTrials.gov |
What this trial studies
This is a single-arm, open-label phase II trial giving afatinib together with chemotherapy as a conversion (pre‑surgical) treatment for patients with unresectable EGFR‑sensitive mutation positive stage III non‑small cell lung cancer. The main goal is to measure how often tumors become resectable after this combined treatment. Secondary outcomes include R0 resection rate, major pathological response, pathological complete response, downstaging, objective response and disease control rates, and survival metrics including event‑free and overall survival. Eligible patients must have confirmed EGFR‑sensitive mutations, ECOG 0–1, at least one measurable lesion, and adequate organ function, and treatment is conducted at a single center in Jinan, Shandong.
Who should consider this trial
Good fit: Ideal candidates are patients with unresectable stage III NSCLC that is positive for EGFR sensitive mutations, with ECOG performance status 0–1, measurable disease, no prior systemic therapy for NSCLC, and adequate organ function.
Not a fit: Patients with malignant pleural effusion, mixed small‑cell or other excluded histologies, prior systemic or local radiotherapy for NSCLC, or uncontrolled gastrointestinal conditions affecting drug absorption are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could convert unresectable tumors into operable disease, potentially allowing curative surgery and improving long‑term outcomes.
How similar studies have performed: Other studies using EGFR tyrosine kinase inhibitors alone or combined with chemotherapy have shown promising tumor responses in EGFR‑mutant NSCLC, but using afatinib plus chemotherapy specifically as conversion therapy remains less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Jinan, Shangdong
- Shandong Public Health Clinical Center — Jinan, Shangdong, China (Recruiting)
Study contacts
- Principal investigator: Hua Zhang, PhD — Shandong Public Health Clinical Center
- Study coordinator: Hua Zhang, PhD
- Email: 95192789@qq.com
- Phone: 0531-83347512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.