Tislelizumab as Cross-line Treatment for Advanced NSCLC

NCT ID: NCT05192681

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2023-10-10

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.

Conditions

Advanced Non-small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tislelizumab arm

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.

Group Type: EXPERIMENTAL

Tislelizumab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Docetaxel

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian cancer hospital

Fuzhou, Fujian, China

Countries

China

Other Identifiers

SCOG003

Identifier Type: -

Identifier Source: org_study_id