Non small cell lung cancer
Conditions
Interventions
Patients with advanced non-small cell lung cancer who cannot use targeted therapy after genetic testing (Sintilimab plus Bevacizumab combined with Pemetrexed and platinum-based therapy):None
Sponsors
Anhui Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible subjects for this study must meet all the following criteria: 1. Age =18 years; 2. Histologically or cytologically confirmed locally advanced (IIIB-IIIC), metastatic or recurrent (Stage IV) NSCLC (according to the 9th edition of TNM lung cancer staging by the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer), not suitable for surgical treatment or radical concurrent chemoradiotherapy, and who have not received prior systemic therapy; 3. Histologically confirmed absence of EGFR gene sensitive mutation, ALK gene fusion, ROS1 gene mutation, and RET gene mutation; 4. At least one radiographically measurable lesion according to RECIST 1.1 criteria. Lesions within a previous radiation field may be considered measurable if progression is confirmed; 5. No prior systemic anti-tumor therapy for advanced/metastatic disease. Subjects who have received adjuvant/neoadjuvant platinum-based chemotherapy or radical chemoradiotherapy for advanced disease are eligible if the interval between disease progression or recurrence and the end of the last chemotherapy treatment is at least 6 months; 6. Subjects with asymptomatic brain metastases or those with stable symptoms after local treatment may be included if the following criteria are met: 1) Measurable lesions outside the central nervous system; 2) No central nervous system symptoms or stable symptoms for at least 2 weeks; 7. ECOG performance status of 0-1; 8. Expected survival time >3 months; 9. Adequate organ function, defined by the following laboratory criteria: 1) Absolute neutrophil count (ANC) =1.5×10^9/L without granulocyte colony-stimulating factor support within 14 days; 2) Platelet count =100×10^9/L without transfusion within 14 days; 3) Hemoglobin >9 g/dL without transfusion or erythropoietin support within 14 days; 4) Total bilirubin =1.5 times the upper limit of normal (ULN); 5) Aspartate transaminase (AST) and alanine transaminase (ALT) =2.5 times ULN (=5 times ULN if liver metastases are present); 6) Serum creatinine =1.5 times ULN and creatinine clearance (calculated by the Cockcroft-Gault formula) =60 ml/min; 7) Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) =1.5 times ULN; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. Subjects with baseline TSH outside the normal range may be eligible if total T3 (or FT3) and FT4 are within the normal range; 9) Normal cardiac enzyme levels (isolated laboratory abnormalities judged as not clinically significant by the investigator are permissible); 10. Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before receiving the first dose of the study drug (Day 1 of Cycle 1). If the urine pregnancy test result is not definitive, a serum pregnancy test is required. Non-childbearing potential is defined as at least 1 year postmenopausal or having undergone surgical sterilization or hysterectomy; 11. All subjects (male and female) must use highly effective contraception methods (with a failure rate of <1% per year) during the study treatment period and for 120 days (or 180 days for some study drugs) after the last dose of the study drug if there is a risk of pregnancy.
Exclusion criteria
Exclusion criteria: Subjects meeting the following criteria will not be eligible for this study: 1. Pathologically confirmed small cell lung cancer (SCLC), including mixed SCLC and NSCLC; 2. Diagnosed with malignancies other than NSCLC within 5 years prior to the first dose (excluding basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been treated with curative intent); 3. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) is not considered systemic treatment; 4. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 5. Known allergy to Sintilimab, Pemetrexed, Gemcitabine, Carboplatin, Cisplatin, or any of their excipients; 6. Known history of human immunodeficiency virus (HIV) infection (i.e., positive HIV 1/2 antibodies); 7. Untreated active hepatitis B (defined as HBsAg positive and HBV DNA copies greater than the upper limit of normal at the research center); Note: Subjects with hepatitis B who meet the following criteria are also eligible: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first dose, and subjects should receive anti-HBV therapy during the chemotherapy period to prevent viral reactivation; 2) Subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-) do not require prophylactic anti-HBV therapy but should be closely monitored for viral reactivation. 8. Receipt of live vaccines within 30 days prior to the first dose (Cycle 1, Day 1); Note: Injection of inactivated virus vaccines for seasonal influenza is permitted within 30 days prior to the first dose; however, live attenuated influenza vaccines for intranasal use are not permitted. 9. Any medical history, condition, treatment, or abnormal laboratory test value that might interfere with the results of the study, compromise the participation of the subject throughout the study, or is deemed inappropriate by the investigator for inclusion in the study due to potential risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;Objective response rate, ORR;Safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, DOR;Disease control rate, DCR;Overall survival, OS; | — |
Countries
China
Contacts
Public ContactQingming Shi
Anhui Chest Hospital
Outcome results
None listed