Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
Recruiting · NCT06709859 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Afatinib plus chemotherapy as conversion treatment
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Shandong Public Health Clinical Center - Jinan, Shangdong, China