Tislelizumab as Cross-line Treatment for Advanced NSCLC

Advanced Non-small-cell Lung Cancer Clinical Trial

Official title:

Tislelizumab Combined With Docetaxel for Cross-line Treatment of First-line Resistant Advanced NSCLC，a Phase II Clinical Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05192681
• Other study ID #: SCOG003
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: October 10, 2021
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2021
• Source: Fujian Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 35
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non-small-cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

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.

Locations

Country	Name	City	State
China	Fujian cancer hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	the PFS of Tislelizumab combining with Docetaxel	five to six months
Secondary	Overall survival	the OS of Tislelizumab combining with Docetaxel	ten to eleven months