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Tislelizumab as Cross-line Treatment for Advanced NSCLC

Primary Purpose

Advanced Non-small-cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
Fujian Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-small-cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian cancer hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival
the PFS of Tislelizumab combining with Docetaxel

Secondary Outcome Measures

Overall survival
the OS of Tislelizumab combining with Docetaxel

Full Information

First Posted
January 5, 2022
Last Updated
January 13, 2022
Sponsor
Fujian Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05192681
Brief Title
Tislelizumab as Cross-line Treatment for Advanced NSCLC
Official Title
Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
Docetaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free survival
Description
the PFS of Tislelizumab combining with Docetaxel
Time Frame
five to six months
Secondary Outcome Measure Information:
Title
Overall survival
Description
the OS of Tislelizumab combining with Docetaxel
Time Frame
ten to eleven months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fujian cancer hospital
City
Fuzhou
State/Province
Fujian
Country
China

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab as Cross-line Treatment for Advanced NSCLC

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