NCT06709859RecruitingPhase 2
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
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
Source: ClinicalTrials.gov · Last updated 17 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 1 May 2025
- Primary completion date
- 31 May 2026
- Lead sponsor
- Shandong Public Health Clinical Center
- Diseases
- Lung cancer
- NCT number
- NCT06709859
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 1 May 2025 to the primary completion date, 31 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior systemic anti-cancer therapy for non-small cell lung cancer
- Prior local radiotherapy for NSCLC
Other illness
- The presence of malignant pleural effusion
- 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
Other
- Histologically or cytologically confirmed combined SCLC and NSCLC, large cell neuroendocrine carcinoma, and sarcoma-like carcinoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shandong Public Health Clinical Center Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.