Tislelizumab as Cross-line Treatment for Advanced NSCLC
NCT05192681 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2022-01-14
Summary
This study is a single-arm, prospective, open phase II clinical study, exploring the efficacy and safety for advanced non-small cell lung cancer after progression of first-line Tislelizumab combined with chemotherapy and continuing Tislelizumab in combination with docetaxel. The primary study endpoint of this study is measured by progression-free survival (PFS).
1. Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle.
2. Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle.
3. Treatment cycle: Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.
Conditions
- Advanced Non-small-cell Lung Cancer
Interventions
- DRUG
-
Tislelizumab
Tislelizumab in combination with docetaxel until the development of PD, unacceptable toxicities, withdrawal of informed consent, end of study, lost to follow-up, or death, whichever occurs first.
Sponsors & Collaborators
-
Fujian Cancer Hospital
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-10-10
- Primary Completion
- 2023-10-10
- Completion
- 2023-10-10
Countries
- China
Study Locations
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