Tislelizumab as Cross-line Treatment for Advanced NSCLC

Phase 2

• Conditions: Advanced Non-small-cell Lung Cancer
• Interventions: Drug: Tislelizumab

• Registration Number: NCT05192681
• Lead Sponsor: Fujian Cancer Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-10
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-14
• Last Update Posted: 2022-01-14
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. 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
2. Patients who have progressed after first-line tislelizumab treatment for more than 3 months
3. No EGFR, ALK gene mutations (the genetic test is not required for patients with lung squamous cell carcinoma)
4. At least one measurable lesion (RECIST standard version 1.1)
5. The expected survival period is ≥3 months
6. The ECOG-PS score is 0-2 points

Exclusion Criteria

1. The tumor histology or cytology is confirmed to be mixed adenosquamous carcinoma or combined with small cell lung cancer
2. Known or suspected active autoimmune diseases
3. A history of immunodeficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and history of allogeneic bone marrow transplantation
4. Interstitial lung disease, drug-induced pneumonia, radiation pneumonia requiring steroid therapy or clinical symptoms, active pneumonia or severe lung dysfunction
5. Symptomatic brain metastases
6. Those who are known or suspected to be allergic to test drugs and their excipients
7. Women who are pregnant or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tislelizumab arm	Tislelizumab	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	five to six months	the PFS of Tislelizumab combining with Docetaxel

Secondary Outcome Measures

Name	Time	Method
Overall survival	ten to eleven months	the OS of Tislelizumab combining with Docetaxel

Trial Locations

Locations (1)

Fujian cancer hospital; 🇨🇳 Fuzhou, Fujian, China