Combining L-TIL and Tislelizumab for advanced lung cancer resistant to PD1 therapy
L-TIL Plus Tislelizumab as Second Line Therapy for PD-1 Inhibitor Resistant Advanced NSCLC Patients
This study is testing a new combination of treatments for people with advanced lung cancer who haven't responded to previous therapies to see if it can help them feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 33 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | radiation, Tislelizumab, chemotherapy |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT05878028 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the efficacy and safety of a combination treatment involving Liquid Tumor Infiltrating Lymphocytes (L-TIL), Tislelizumab, and Docetaxel in patients with advanced non-small cell lung cancer (NSCLC) who have not responded to prior PD1 inhibitor therapy. Participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cell infusion, and one year of Tislelizumab treatment. The study focuses on patients without actionable biomarkers and assesses their response to this novel treatment regimen. The trial is conducted at a single center and includes a comprehensive evaluation of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with stage IV non-small cell lung cancer that has not responded to prior PD1 inhibitor therapy.
Not a fit: Patients with actionable biomarkers such as EGFR, ALK, ROS1, RET, or MET, or those with active infections or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced NSCLC who are resistant to standard PD1 antibody therapies.
How similar studies have performed: While there is ongoing research in this area, the specific combination of L-TIL and Tislelizumab for PD1-resistant NSCLC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Zhengzhou, Henan
- No.127 Dongming Road — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Quanli NA Gao, PhD
- Email: zlyygql@zzu.edu.cn
- Phone: 86-0371-65587951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.