Status:
UNKNOWN
Tislelizumab as Cross-line Treatment for Advanced NSCLC
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Advanced Non-small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- Advanced non-small cell lung cancer diagnosed by histology or pathology, and has progressed after first-line treatment with tislelizumab combined with platinum-containing dual-drug chemotherapy
- Patients who have progressed after first-line tislelizumab treatment for more than 3 months
- No EGFR, ALK gene mutations (the genetic test is not required for patients with lung squamous cell carcinoma)
- At least one measurable lesion (RECIST standard version 1.1)
- The expected survival period is ≥3 months
- The ECOG-PS score is 0-2 points
Exclusion
- The tumor histology or cytology is confirmed to be mixed adenosquamous carcinoma or combined with small cell lung cancer
- Known or suspected active autoimmune diseases
- A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinical symptoms, active pneumonia or severe lung dysfunction
- Symptomatic brain metastases
- Those who are known or suspected to be allergic to test drugs and their excipients
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2023
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05192681
Start Date
October 10 2021
End Date
October 10 2023
Last Update
January 14 2022
Active Locations (1)
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1
Fujian cancer hospital
Fuzhou, Fujian, China