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Tislelizumab as Cross-line Treatment for Advanced NSCLC

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05192681
Collaborator
(none)
35
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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).

  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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study
Actual Study Start Date :
Oct 10, 2021
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Oct 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: 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.
Other Names:
  • Docetaxel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [five to six months]

      the PFS of Tislelizumab combining with Docetaxel

    Secondary Outcome Measures

    1. Overall survival [ten to eleven months]

      the OS of Tislelizumab combining with Docetaxel

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fujian cancer hospital Fuzhou Fujian China

    Sponsors and Collaborators

    • Fujian Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fujian Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05192681
    Other Study ID Numbers:
    • SCOG003
    First Posted:
    Jan 14, 2022
    Last Update Posted:
    Jan 14, 2022
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carcinoma, Non-Small-Cell Lung
    Docetaxel

    Study Results

    No Results Posted as of Jan 14, 2022