L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

Trial Title: L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

NCT ID: NCT05878028

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Docetaxel
Tislelizumab

Conditions: Keywords:
L-TIL
PD1 antibody resistance
Tislizumab
Chemotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Combination Product
Intervention name: L-TIL, Tislelizumab, Docetaxel
Description: 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.
Arm group label: L-TIL plus Tislelizumab and Docetaxel

Other name: Liquid Tumor Infiltrating Lymphocytes

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Non-small cell lung cancer patients diagnosed by pathological histology. - Imaging examination showed stage IV disease. - Non-squamous cancer patients shall be EGFR , ALK, ROS1, RET, MET negative. - Failure from anti-PD-1 antibody treatment, including treatment ineffective or effective for a period then progress. - The Eastern Oncology Collaboration Group (ECOG) scores 0-1. - At least one imaging lesion can be measured, according to the standard for evaluating the effectiveness of solid tumors (RECIST 1.1). - Asymptomatic or stable symptoms after local treatment is allowed. - Subjects are allowed to receive palliative radiation. - Enough organ functions well. - Patients have good superficial venous blood circulation, which can meet the needs of intravenous dripping. - No other serious diseases that conflict with this study regimes (e.g. autoimmune diseases, immune deficiencies, organ transplants, chronic infections). - For female subjects with reproductive age, the pregnancy test should be accepted within 3 days prior to the first study drug administered (day 1 of cycle 1) and the results are negative. - In the event of a risk of conceival, all subjects (male or female) must adopt contraception at a rate of less than 1% annually for the entire treatment period up to 120 days after the last study of the drug was administered (or 180 days after the last study of the drug). - The patient himself agrees to participate in this clinical trial, sign the Informed Consent Letter, complete the procedure, treatment, and follow-up. Exclusion Criteria: - Small cell lung cancer (SCLC), including mixing pathology, combined with SCLC and NSCLC. - Accepted radiation treatment in special organ before the first drug was administered, eg: more than 30% bone marrow within 14 days. - Diagnosed with second malignant diseases within five years. - Participating in other clinical trial. - Treatment with other drugs, including thymus peptide, interferon, interleukin, and so on. - Active autoimmune diseases requires systemic treatment. - Receiving glucocorticoid therapy, excluding local glucocorticoids in nose, inhalation or other pathways, or any other form of immunosuppressive therapy. - Uncontrolled chest and abdominal fluid. - Patients have accepted organ transplantation or hematopoietic stem cell transplantation. - Allergic to intervention drugs, including ingredients and auxiliary components. ·Incomplete recovery from the adverse events. - Active hepatitis B or HCV infection. - Accepted active vaccines within 30 days before the first dose. - Women who are pregnant or breastfeeding. - Symptomatic CNS metastasis. - Uncontrolled active infections, eg. sepsis, mycemia, fungal hematoma. - With serious mental disorders. - Other conditions that the researchers believe in having potential risks which are not suitable for this study.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: No.127 Dongming Road

Address:
City: Zhengzhou
Zip: 450000
Country: China

Status: Recruiting

Contact:
Last name: Xiaomin NA Fu, PhD

Phone: 86-0371-65587187
Email: fuxiaomin0880@126.com

Start date: September 16, 2022

Completion date: September 15, 2025

Lead sponsor:
Agency: Quanli Gao
Agency class: Other

Source: Henan Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05878028