Advanced squamous non-small cell lung cancer
Conditions
Interventions
Experimental group:Recombinant human endostatin+trilaciclib+immunotherapy+platinum based chemotherapy
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy; 3. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; 5. Had not received any previous systemic antitumor therapy for advanced/metastatic disease. Patients who had received previous platinum-based adjuvant or neoadjuvant chemotherapy or definitive chemoradiotherapy for advanced disease were allowed if they had disease progression or relapse at least 6 months after the last dose of chemotherapy. 6. Expected survival time >3 months; 7. Adequate organ and bone marrow function and laboratory values within the 7 days before enrollment (no administration of blood components, cell growth factors, albumin, or other corrective medications during the 14 days before laboratory testing was obtained) were required, as follows: 1) Complete blood count: absolute neutrophil count (ANC) >=1.5×109/L, platelet (PLT) >=75×109/L, hemoglobin (HGB) >=90 g/L (no blood transfusion or erythropoietin dependence within 14 days) 2) Liver function: serum total bilirubin (TBIL) =28 g/L; alkaline phosphatase (ALP=50 mL/min (using the standard Cockcroft-Gault formula) : urine routine results showed urine protein < 2+; Patients with a urine protein level of 2+ or more on routine urinalysis at baseline should undergo a 24-hour urine collection with a 24-hour urinary protein quantification of less than 1g. 4) Coagulation function: INR or PT <=1.5 times ULN; If the subject was receiving anticoagulant therapy, the INR was within the intended range for anticoagulant therapy. 8. For women of childbearing age, a negative urine or serum pregnancy test should be performed 3 days prior to receiving the first dose of study drug; 9. Participants and their sexual partners are required to use a medically approved contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study treatment period and for 6 months after the end of the study treatment period.
Exclusion criteria
Exclusion criteria: 1. Histologically non-squamous cell NSCLC; 2. Patients with known EGFR sensitive mutations or ALK rearrangements; 2. 3. If the tumor had invaded large blood vessels by imaging (CT or MRI) or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; 4. Currently participating in an interventional clinical study treatment, or receiving another study drug or study device within 4 weeks before the first dose; 5. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137); 6. Received Chinese patent medicine or immunomodulatory drugs (thymosin, interferon, interleukin, etc.) with anti-tumor indications within 2 weeks before the first dose, or received major surgical treatment within 3 weeks before the first dose; 7. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; 8. Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias; 9. Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; 10. Known allergic reactions to PD-1/L1 monoclonal antibodies, taxanes, cisplatin or carboplatin, recombinant human endostatin, the active ingredient of treaclib, and or any excipients; 11. Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible. 12. Presence of leptomeningeal metastases and other symptomatic central nervous system metastases; 13. Active infection requiring treatment or use of systemic anti-infective drugs within one week before the first dose; 14. Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade =1 or at baseline, excluding fatigue or alopecia); 15. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 16. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal range in the laboratory of the participating center); Note: Subjects with hepatitis B who met the following criteria were also eligible for inclusion: 1) Subjects with HBV viral load <1000 copies /ml (200 IU/ml) before the first dose should receive anti-HBV therapy throughout the study chemotherapy to avoid viral reactivation 2) For subjects with anti-HBc (+), HBsAg (-), anti-hbs (-) and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation should be closely monitored 17. Active HCV-infected subjects (HCV-antibody positive and HCV-RNA level above the lower limit of detection); 18. Received a live vaccine within 30 days before the first dose (cycle 1, day 1); 19. Pregnant or lactating women; 20. Medical history or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial, prevent the subjects from participating in the study fully, or other conditions considered by the investigator to be unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12month-PFS;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;DOR;OS;Satety;myelosuppression benefits; | — |
Countries
China
Contacts
Public ContactTianqing Chu
Shanghai Chest Hospital
Outcome results
None listed