- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Quanli NA Gao, PhD
- Phone Number: 86-0371-65587951
- Email: zlyygql@zzu.edu.cn
Study Contact Backup
- Name: Xiaomin NA Fu, PhD
- Phone Number: 86-0371-65587483
- Email: fuxiaomin0880@126.com
Study Locations
-
-
Henan
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Zhengzhou, Henan, China, 450000
- Recruiting
- No.127 Dongming Road
-
Contact:
- Xiaomin NA Fu, PhD
- Phone Number: 86-0371-65587187
- Email: fuxiaomin0880@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
- 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. 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
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:
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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
Sponsor
Investigators
- Study Chair: YanYan NA Liu, phD, Henan Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Docetaxel
- Tislelizumab
Other Study ID Numbers
- HenanCH L-TIL aNSCLC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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