Recruiting
Phase 2
Afatinib Combined With Chemotherapy as Conversion Therapy in Unresectable EGFR Sensitive Mutation-positive Stage III NSCLC
About this study
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.
- Condition
- Carcinoma, Non-Small-Cell Lung
- Tested
- Afatinib plus chemotherapy as conversion treatment
- Sponsor
- Shandong Public Health Clinical Center
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Carcinoma, Non-Small-Cell Lung
- 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 5
- 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
1 site, 1 recruiting
Shandong Public Health Clinical Center
Jinan, Shangdong, China
Contact
-
Hua Zhang, PhD
0531-83347512 95192789@qq.com
Potential match only. Final eligibility is determined by the study team.