Actively Recruiting
L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC
Led by Quanli Gao · Updated on 2024-05-23
33
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-small cell lung cancer by pathological histology
- Stage IV disease confirmed by imaging examination
- Non-squamous patients must be negative for EGFR, ALK, ROS1, RET, MET
- Failure of anti-PD-1 antibody treatment, including no effect or progression after initial response
- Eastern Oncology Collaboration Group (ECOG) score of 0 or 1
- At least one measurable lesion by RECIST 1.1 criteria
- Asymptomatic or stable symptoms after local treatment allowed
- Palliative radiation is permitted
- Adequate organ function
- Good superficial venous blood circulation suitable for intravenous infusion
- No serious diseases conflicting with study treatment (e.g., autoimmune diseases, immune deficiencies, organ transplants, chronic infections)
- Negative pregnancy test within 3 days before first study drug administration for women of reproductive age
- Use of contraception with less than 1% failure rate during treatment and up to 120 days after last drug dose (180 days for some drugs)
- Signed informed consent and willingness to complete study procedures, treatment, and follow-up
You will not qualify if you...
- Small cell lung cancer or mixed pathology including small cell lung cancer
- Radiation treatment involving more than 30% bone marrow within 14 days before first drug administration
- Diagnosis of second malignant disease within the past five years
- Participation in other clinical trials
- Treatment with other drugs such as thymus peptide, interferon, or interleukin
- Active autoimmune diseases requiring systemic treatment
- Receiving glucocorticoid therapy except local nasal or inhaled forms or other immunosuppressive therapy
- Uncontrolled chest or abdominal fluid
- History of organ or hematopoietic stem cell transplantation
- Allergic to study drugs or their components
- Incomplete recovery from adverse events
- Active hepatitis B or HCV infection
- Receipt of active vaccines within 30 days before first dose
- Pregnant or breastfeeding women
- Symptomatic central nervous system metastasis
- Uncontrolled active infections such as sepsis or fungal infections
- Serious mental disorders
- Other conditions deemed risky by researchers for study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
No.127 Dongming Road
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
Q
Quanli NA Gao, PhD
CONTACT
X
Xiaomin NA Fu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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