Tislelizumab as Cross-line Treatment for Advanced NSCLC

Study Overview
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Brief Summary
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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). Tislelizumab: The recommended dose is 200 mg/dose administered every three weeks on the first day of each cycle. Docetaxel: 60-75 mg/m2 every 3 weeks, administered on day 1 of each cycle. 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.

Official Title
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Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study

Conditions
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Advanced Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Tislelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tislelizumab arm<br>Tislelizumab: 200 mg, intravenous infusion, administered on the 1st day of each cycle, every 3 weeks Docetaxel: 60-75mg/m2 administered on the 1st day of each cycle, every 3 weeks Treatment until the disease progresses or intolerable side effects appear. | Drug: Tislelizumab<br>* 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.<br>* Other names: Docetaxel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the PFS of Tislelizumab combining with Docetaxel | five to six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | the OS of Tislelizumab combining with Docetaxel | ten to eleven months |