Lung cancer
Conditions
Interventions
Experimental group:1. Tolecimab, 300mg, administered subcutaneously into the abdomen on Day 1 of each cycle, for 1 cycle every 3 weeks (Q3W).
2. Sintilimab, 200mg, administered by intravenous infusion
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures; 2. Age>=18 years old and 6 months); 5. No EGFR gene sensitivity mutations, ALK gene fusion mutations, ROS1 gene mutations, and RET gene mutations were confirmed by histological specimens; 6. At least one measurable lesion on imaging according to the efficacy evaluation criteria for solid tumors (RECIST v1.1). Lesions located in the field of prior radiotherapy can be considered measurable if progression is confirmed; 7. Subjects with brain metastases who are asymptomatic or symptomatic after local treatment are allowed to enroll, as long as the subjects meet the following conditions: (1) Measurable lesions outside the central nervous system; (2) No central nervous system symptoms or no aggravation of symptoms in at least 2 weeks; (3) No glucocorticoid therapy is required, or glucocorticoid therapy is discontinued within 7 days before the first dose, or the glucocorticoid dosage is stable and reduced to less than 10mg/day prednisone (or equivalent dose) within 7 days before the first dose; 8. Subjects are allowed to receive palliative radiation therapy (including cranial radiation therapy for symptomatic brain metastases), provided that the radiotherapy is terminated at least 1 week prior to enrollment and that the radiotherapy-related toxicity recovers to less than or equal to 1 grade (CTCAE 5.0, except for alopecia); 9. ECOG score 0-2 points; 10. Expected survival time> 3 months; 11. Adequate organ function, subjects need to meet the following laboratory indicators: (1) In the case of no granulocyte colony-stimulating factor in the past 14 days, the absolute value of neutrophils (ANC) >=1.5x10^9/L; (2) In the case of no blood transfusion in the past 14 days, platelet >=100×10^9/L; (3) In the absence of blood transfusion or erythropoietin in the past 14 days, hemoglobin > 9g/dL; (4) total bilirubin =60 ml/min; (7) Good 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 normal limits. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to enroll); 12. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Females of non-childb
Exclusion criteria
Exclusion criteria: 1. The pathology is small cell lung cancer (SCLC), including lung cancer with mixed SCLC and NSCLC; 2. Patients have received more than first-line PD-(L)1 inhibitor monotherapy or combination chemotherapy; 3. Have received the following treatments: (1) Received systemic anti-tumor therapy, such as chemotherapy, targeted therapy, immunotherapy (including Chinese herbal medicine therapy with anti-tumor indications) within 3 weeks prior to treatment; (2) Treatment with any investigational drug within 4 weeks prior to treatment; (3) Receipt of high-dose immunosuppressive drugs (systemic glucocorticoids exceeding 10mg/day of prednisone or its equivalent) within 4 weeks prior to treatment; (4) Received a live attenuated vaccine within 4 weeks prior to treatment (or plans to receive a live attenuated vaccine during the study); (5) Major surgery (such as open, thoracotomy, or Kaifu surgery) within 4 weeks prior to treatment, or surgical wounds, ulcers, or fractures that have not healed. 4. Presence of clinically uncontrollable pleural effusion/ascites effusion (subjects who do not need to drain the effusion or who have stopped draining for 3 days without a significant increase in the effusion may be enrolled); 5. Subjects who have received chest radiation therapy greater than 30Gy within 6 months prior to treatment or palliative radiation therapy at doses of 30Gy and less within 7 days prior to treatment (palliative radiation therapy for bone lesions or intracranial lesions is allowed); 6. Active autoimmune disease requiring systemic therapy (e.g., use of disease-modifying medications, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroxine, insulin, or for the adrenal or pituital glands.) physiologic glucocorticoids for insufficiency) are not considered systemic therapy; 7. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 8. Those who are known to be allergic to the active ingredients or excipients of sintilimab and tolecimab of this investigational drug; 9. Have not recovered adequately from toxicity and/or complications induced by any of the interventions (i.e., = Grade 1 or to baseline, excluding fatigue or alopecia, prior to initiation of treatment); 10. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 11. Untreated active hepatitis B (defined as HBsAg positivity and detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Note: Subjects with hepatitis B who meet the following criteria may also be enrolled: (1) HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the study drug treatment period to avoid viral reactivation; (2) prophylactic anti-HBV therapy is not required for subjects with anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), but requires close monitoring for viral reactivation; 12. Subjects with active HCV infection (HCV antibody positive and HCV-RNA levels above the lower limit of detection); 13. Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Injectable inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; However, intranasal live attenuated influenza vaccine is not permitted. 14. Pregnant or lact
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactZiming Li
Shanghai Chest Hospital
Outcome results
None listed