Afatinib plus chemotherapy to convert unresectable EGFR‑mutant stage III NSCLC into resectable disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Amivantamab with Lazertinib or Chemotherapy before surgery in EGFR-mutated NSCLC

  This study tests whether giving amivantamab together with lazertinib or with carboplatin and pemetrexed before surgery can slow or stop tumor growth in people with resectable EGFR-mutated NSCLC.

  Recruiting at 27 sites Phase 2 Janssen Research & Development, LLC · Duarte, California and 26 other locations · NCT07586202

• Multidisciplinary treatment planning for older people with lung cancer

  We will test a team-based approach that uses geriatric assessments to create personalized treatment plans for people aged 60–90 with newly diagnosed lung cancer to see if it improves 3-year progression-free survival compared with past patients.

  Recruiting West China Hospital · Chengdu, Sichuan · NCT07509333

• Dabrafenib and trametinib for rare cancers with BRAF V600 mutations

  This arm tests whether dabrafenib and trametinib can help adults, children, and teens with cancers that have a BRAF V600 mutation.

  Recruiting at 15 sites Phase 2/3 Cancer Research UK · Belfast and 26 other locations · NCT07440290

• Intratumoral injection of N17350 in advanced solid tumors

  Aims to see if injected N17350 can shrink or control tumors in adults with advanced solid cancers who have few other options.

  Recruiting at 7 sites Phase 1/2 Onchilles Pharma Inc · Los Angeles, California and 8 other locations · NCT07339176

• Clinical outcomes of amivantamab-based treatment for advanced EGFR-mutated non-small cell lung cancer in everyday care.

  This project will see how amivantamab-containing treatments work for people with advanced non-small cell lung cancer who have common EGFR mutations.

  Recruiting at 90 sites Janssen Research & Development, LLC · Graz and 89 other locations · NCT07230691

• PF-08634404 combined with other cancer medicines for advanced non-small cell lung cancer

  This will test whether PF-08634404 given with other cancer medicines is safe and can help adults with advanced or metastatic non-small cell lung cancer.

  Recruiting at 85 sites Phase 1/2 Pfizer · Fayetteville, Arkansas and 103 other locations · NCT07227298

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.