A Phase 2 interventional study of L-TIL, Tislelizumab, Docetaxel in Non-small Cell Lung Cancer, sponsored by Quanli Gao. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Quanli Gao · Phase 2, Interventional, and Treatment
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.
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 33 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Quanli Gao is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Tislelizumab, 200mg, ivgtt, d1, Q3W for one year L-TIL cells, （3-10）x10\^9/m2, ivgtt, d14, Q3W for 4 or 6 cycles Docetacel, 75mg/m2, ivgtt, d1, Q3W for 4 cycles
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.
Also known as: Liquid Tumor Infiltrating Lymphocytes
ORR
overall response rate (including complete response and partial response)
Time frame: 3 months
PFS
duration of disease stable or better
Time frame: 6 months and 12 months
DCR
disease control rate (including patients who achieved complete response, partial response and stable disease)
Time frame: 3 months
DOR
duration of response
Time frame: 6 months and 12 months
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Carcinoma, Non-Small-Cell Lung→