Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer
Phase 2
Completed
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04144582
- Lead Sponsor
- Yongchang Zhang
- Brief Summary
The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Life expectancy exceeds 3 months
- The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.
Exclusion Criteria
- small cell lung cancer or small cell lung cancer
- Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
- Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Sintilimab Combined With Docetaxel Sintilimab Combined With Docetaxel Monotherapy Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer
- Primary Outcome Measures
Name Time Method ORR Approximately 1 years To measure the patients's overall response rate
- Secondary Outcome Measures
Name Time Method PFS Approximately 1 years Progression free survival
OS Approximately 1 years Overall survival
Trial Locations
- Locations (2)
Yongchang Z MD
🇨🇳Changsha, Hunan, China
Hunan Provincal Tumor Hospital
🇨🇳Changsha, Hunan, China