L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC

May 17, 2023 updated by: Quanli Gao

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

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.

Study Overview

Status

Recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • No.127 Dongming Road
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Non-small cell lung cancer patients diagnosed by pathological histology. 2. Imaging examination showed stage IV disease. 3. Non-squamous cancer patients shall be EGFR , ALK, ROS1, RET, MET negative. 5. Failure from PD-1 antibodies treatment, including treatment ineffective or effective for a period then progress.

6. The Eastern Oncology Collaboration Group (ECOG) scores 0-1. 7. At least one imaging lesion can be measured, according to the standard for evaluating the effectiveness of solid tumors (RECIST 1.1).

8. Asymptomatic or stable symptoms after local treatment is allowed. 9. Subjects are allowed to receive palliative radiation. 10. Enough organ functions well. 11. Patients have good superficial venous blood circulation, which can meet the needs of intravenous dripping.

12. No other serious diseases that conflict with this study regimes (e.g. autoimmune diseases, immune deficiencies, organ transplants, chronic infections).

13. 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.

14. 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).

15. The patient himself agrees to participate in this clinical trial, sign the Informed Consent Letter, complete the procedure, treatment, and follow-up.

Exclusion Criteria:

  1. Small cell lung cancer (SCLC), including mixing pathology, combined with SCLC and NSCLC.
  2. Accepted radiation treatment in special organ before the first drug was administered, eg: more than 30% bone marrow within 14 days.
  3. Diagnosed with second malignant diseases within five years.
  4. Participating in other clinical trial.
  5. Treatment with other drugs, including thymus peptide, interferon, interleukin, and so on.
  6. Active autoimmune diseases requires systemic treatment.
  7. Receiving glucocorticoid therapy, excluding local glucocorticoids in nose, inhalation or other pathways, or any other form of immunosuppressive therapy.
  8. Uncontrolled chest and abdominal fluid.
  9. Patients have accepted organ transplantation or hematopoietic stem cell transplantation.
  10. Allergic to intervention drugs, including ingredients and auxiliary components. 11. Incomplete recovery from the adverse events.

12. Active hepatitis B or HCV infection. 13. Accepted active vaccines within 30 days before the first dose. 14. Women who are pregnant or breastfeeding. 15. Symptomatic CNS metastasis. 16. Uncontrolled active infections, eg. sepsis, mycemia, fungal hematoma. 17. With serious mental disorders. 18. Other conditions that the researchers believe in having potential risks which are not suitable for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: L-TIL plus Tislelizumab and Docetaxel
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
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.
Other Names:
  • Liquid Tumor Infiltrating Lymphocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 3 months
overall response rate (including complete response and partial response)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 months and 12 months
duration of disease stable or better
6 months and 12 months
DCR
Time Frame: 3 months
disease control rate (including patients who achieved complete response, partial response and stable disease)
3 months
DOR
Time Frame: 6 months and 12 months
duration of response
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: YanYan NA Liu, phD, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Estimated)

September 15, 2023

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

May 17, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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