L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

NCT05878028 | Recruiting Phase 2

• 1 other identifier: HenanCH L-TIL aNSCLC
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

L-TIL; PD1 antibody resistance; Tislizumab; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate (including complete response and partial response)

  3 months

Secondary Outcomes (3)

• PFS

  6 months and 12 months

• DCR

  3 months

• DOR

  6 months and 12 months

Study Arms (1)

L-TIL plus Tislelizumab and Docetaxel

EXPERIMENTAL

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

Interventions

L-TIL, Tislelizumab, Docetaxel COMBINATION_PRODUCT

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

L-TIL plus Tislelizumab and Docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quanli Gao: lead

Study Sites (1)

No.127 Dongming Road

Zhengzhou, Henan, 450000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• YanYan NA Liu, phD

  Henan Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Quanli NA Gao, PhD

CONTACT

86-0371-65587951; zlyygql@zzu.edu.cn

Xiaomin NA Fu, PhD

CONTACT

86-0371-65587483; fuxiaomin0880@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Immunotherapy department

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 26, 2023
• Study Start: September 16, 2022
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CN (1)