NCT05878028

L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

L-TIL Plus Tislelizumab as Second Line Therapy for PD-1 Inhibitor Resistant Advanced NSCLC Patients

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Quanli Gao · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. However, there is no standard regimen for the patients who refractory from the first-line PD1 inhibitor based therapy. The main questions they aim to answer are: 1.The efficacy of Liquid Tumor Infiltrating Lymphocytes (L-TIL) plus Tislelizumab and Docetaxel for patients failure from first line chemotherapy and PD1 inhibitor therapy. 2. The safety of L-TIL plus Tislelizumab and Docetaxel as second line therapy. All participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab treatment except for disease progression, intolerable toxicity, withdrawal informed consent, death and so on.

Detailed description

This study is one arm, single center, phase II clinical trial. The participants were diagnosed with metastatic non-small cell lung cancer but without actionable biomarkers (eg: EGFR, ALK, MET, ROS1). PD1 inhibitor and chemotherapy as first line therapy was not respond, or develop tumor progression after a response. Four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab regimen Q3W were used. Docetacxel was dosed 75mg/m2 and Tislelizumab was dosed 200mg on day 1, L-TIL cells were dosed (3-10)x10\*9/m2 on day 14. Eligible patients were no less than 18 and no more than 75 years old, with adequate organ function but without active infection and autoimmune disease.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	L-TIL, Tislelizumab, Docetaxel	PD1 positive lymphocytes were collect, isolated, and expanded from peripheral blood, then infused back into the patient's body. Besides this, Tislelizumab and Docetaxel were used as combination therapy.

Timeline

• Start date: 2022-09-16
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2023-05-26
• Last updated: 2024-05-23

Locations

1 site across 1 country: China