Tislelizumab as Cross-line Treatment for Advanced NSCLC

NCT05192681 | Unknown Phase 2

• 1 other identifier: SCOG003
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  the PFS of Tislelizumab combining with Docetaxel

  five to six months

Secondary Outcomes (1)

• Overall survival

  ten to eleven months

Study Arms (1)

Tislelizumab arm

EXPERIMENTAL

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

Interventions

Tislelizumab 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.

Also known as: Docetaxel

Tislelizumab arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Fujian cancer hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Interventions

tislelizumab; Docetaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 14, 2022
• Study Start: October 10, 2021
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: January 14, 2022

Record last verified: 2021-10

Locations

CN (1)