Non small cell lung cancer
Conditions
Interventions
Cohort with TIL treatment:TIL combined with PD-1 monopoly antibody
Sponsors
The First Affiliated Hospital of USTC
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary participation and sign informed consent; 2. Aged 18 to 70 years; 3. Diagnosis of unresectable stage IIIB~IV non small cell lung cancer; 4. Those with EGFR / ALK / ROS1 and other wild-type driver genes failed in first-line platinum containing chemotherapy (including, but not limited to pemetrexed / docetaxel / paclitaxel / gemcitabine combined with platinum drugs); 5. Must have progressed following at least one line of standard treatment, and there is no alternative effective treatment (effective treatment refers to the latest version of diagnosis and treatment guidelines for various cancers); 6. At least one resectable lesion (or invaded superficial lymph nodes, or aggregate of lesions resected) of a minimum 0.5cm3 for resection to generate TIL. Minimally invasive surgery is preferred. This lesion cannot be in previously irradiated areas or other local therapy; 7. At least one another measurable target lesion after resection, as defined by RECIST v1.1. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was >= 3 months prior to screening, and there has been demonstrated disease progression in that particular lesion; 8. ECOG=0 or 1; 9. Expected survival time >= 12 weeks; 10. Patients must have adequate organ function: 1) Hematologic parameters: Absolute neutrophil count (ANC) >= 1.5x10^9/L; Lymphocyte counts(LC)> 0.5x10^9/L; Platelet >= 100x10^9/L; Hemoglobin (Hb) >= 90g/L; 2) AST, ALT and alkaline phosphatase == 45 mL/min using the Cockcroft-Gault formula, or serum creatinine in normal range; 4) APTT == 50%; 6) FEV1 >= 60%; 11. Patients of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the study and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy. Non surgically sterilized female subjects of reproductive age must be negative for serum hCG testing within 7 days prior to cell infusion; 12. Patients must have recovered from all prior therapy-related adverse events (AEs) to == Grade 2 diarrhea or colitis as a result of previous treatment with immune checkpoint inhibitor(s) must have been asymptomatic for at least 6 months and/or had a normal colonoscopy post-immune checkpoint inhibitor treatment, by visual assessment, prior to tumor resection; 13. Before resection, the imaging evidence of disease progress after prior line treatment should be documented.
Exclusion criteria
Exclusion criteria: 1. Patients with symptomatic and/or untreated CNS metastases (Patients with definitively treated brain metastases may be considered for enrollment and must be stable for >= 14 days without drug treatment and steroid-dependent); 2. Failure of surgery and/or radiotherapy to relieve spinal cord compression; 3. Malignant tumors other than melanoma within the 5 years prior to screening, except for fully treated basal cell or squamous cell skin cancer, breast ductal carcinoma in situ after radical surgery; 4. Uncontrolled tumor related pain judged by the investigator. Subjects requiring pain medication must have had a stable pain medication regimen at the time of enrollment; Symptomatic lesions amenable to palliative radiotherapy should have completed treatment before enrollment; 5. Interstitial pneumonia or clinically significant active pneumonia, or other respiratory disease severely affecting lung function; 6. Any active autoimmune disease; a history of autoimmune disease or disease requiring treatment with systemic steroids or immunosuppressive drugs; 7. Patients with a history of significant cardiovascular disease, including: 1) Congestive heart failure (NYHA functional classification > Class 2); 2) Unstable angina; 3) myocardial infarction occurred in past 3 months; 4) Any supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention; 8. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring; 9. Patients with active tuberculosis infection within 1 year before enrollment, or with a history of active tuberculosis infection beyond 1 year before but without standard treatment; 10. Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever > 38.5? occurring during the screening period, except for tumor fever; 11. Patients with a history of immunodeficiency, including HIV seropositivity; 12. Patients with active hepatitis B or C. Patients with seropositive HBsAg or HBcAb can be enrolled while negative HBV DNA. Patients with seropositive HCV antibody can be enrolled while negative HCV RNA. If potential carriers enrolled, proper anti-virus treatment and regular nucleotide test should be arranged; 13. Patients with contraindications to IL-2 use, such as refractory or intractable epilepsy or active gastrointestinal bleeding; 14. Patients who have received a live or attenuated vaccination within 28 days prior to enrollment, or expected during the study; 15. Patients who have received long half-life anti angiogenic drugs within four weeks prior to enrollment, such as the VEGF bevacizumab; 16. Patients who plan to receive other clinical trial drugs during the study period; 17. Patients who have received an organ allograft or prior cell transfer therapy; 18. Patients who have a history of hypersensitivity to any component or excipient of GT101 or other study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin); 19. Known psychiatric disorders, alcohol, drug or substance abuse; 20. According to the judgment of the researcher, any case that meets the contraindication of PD-1 monoclonal antibody is found; 21. Any disease or condition (any other condition, metabolic disor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance;Objective Response Rate (ORR);Disease Control Rate (DCR);Progression-Free-Survival(PFS);Duration of Respons(DOR);Overall Survival (OS); | — |
Countries
China
Contacts
Public ContactCao Lejie
The First Affiliated Hospital of USTC
Outcome results
None listed