lung cancer
Conditions
Interventions
Test group:QL1706 plus anlotinib and chemotherapy
Sponsors
The First Affiliated Hospital of Bengbu Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent; 2. Age >= 18 years old, male or female; 3. Patients with advanced NSCLC confirmed by histopathology, cytology or clinic; 4. NSCLC patients with EGFR sensitive mutations (deletion mutation in exon 19 or L858R mutation in exon 21) and drug resistance after first / second / third generation EGFR-TKI treatment according to genetic testing; 5. At least 1 measurable lesion (based on RECIST v1.1 evaluation); 6. ECoG physical fitness status score (PS score): 0-1; 7. Estimated survival >= 3 months; 8. The functional level of important organs within 3 days before the first administration must meet the following requirements (supportive treatment, such as any blood component, is not allowed within 14 days before the first administration); a) The absolute neutrophil count >= 1.5 × 10^9 / L; b) Platelets >= 50 × 10^9/l; c) Hemoglobin >= 90 g/l; d) Serum albumin >= 30 g/l; e) AST and alt 1.5 × ULN, the creatinine clearance (clcr) calculated by Cockcroft Gault equation is >= 50 ml / min; h) Proteinuria = 2+, 24h urine protein quantitation should be performed, and <= 1g can be selected); i) International normalized ratio (INR) <= 1.5; Activated partial thromboplastin time (APTT) <= 1.5 × ULN; 9. If you have hepatitis B virus (HBV) infection, you should receive anti HBV treatment for at least 1 week before enrollment and are willing to receive antiviral treatment throughout the study period; Hepatitis C virus (HCV) RNA positive patients must receive antiviral treatment according to the treatment guidelines and liver function within CTCAE grade 1 elevation; 10. Women of childbearing age must have a negative pregnancy test (ß -hcg) before starting treatment, and women of childbearing age and men (who have sex with women of childbearing age) must agree to contraception during treatment and within 6 months of the last treatment. 11. Patients who the researcher believes can benefit.
Exclusion criteria
Exclusion criteria: 1. Patients with confirmed small cell lung cancer; 2. Previous combination of anti-CTLA-4 and anti pd- (L) 1; 3. Other active malignant tumors other than NSCLC within 5 years or at the same time; 4. Those who are allergic to anlotinib or ingredients; 5. Patients with central lung squamous cell carcinoma or high risk of hemoptysis; 6. Patients with active bleeding or severe bleeding tendency; 7. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, breast cancer in situ, etc., can be enrolled; 8. Before the first dose of study treatment, there was toxicity caused by previous anti-tumor treatment that did not return to grade 1 of National Cancer Institute general adverse event terminology version 5.0 (NCI CTCAE V5.0) (excluding hair loss, non clinically significant and asymptomatic laboratory abnormalities); 9. Patients who permanently discontinued immune checkpoint inhibitors due to any adverse event Common Terminology Criteria (CTCAE) >= grade 3 or other immune related toxicity in previous treatment; 10. There are serious comorbidities, including serious heart, lung, kidney, coagulation dysfunction, important cardiovascular diseases (such as unstable arrhythmia, unstable angina, myocardial infarction, cerebral infarction, etc.); 11. Pregnant and lactating women; 12. Systemic infection or other serious infection requiring intravenous antibiotic treatment for >7 days within 2 weeks before the first administration, or unexplained fever >38.5 degrees during screening and before enrollment (except for the fever caused by tumor according to the judgment of the investigator); 13. Diagnosed with immune deficiency or received systemic steroid therapy or any other form of immunosuppressive therapy or immunomodulator therapy within 7 days before the first dose of study drug; 14. Patients with clinically significant bleeding symptoms or clear bleeding tendency within 6 months before enrollment, such as gastrointestinal bleeding, severe esophageal and gastric varices, hemorrhagic gastric ulcer or vasculitis, can be reexamined if stool occult blood is positive in the baseline period. If it is still positive after reexamination, gastroscopy is required; 15. Known genetic or acquired bleeding (such as coagulation dysfunction) or thrombophilia, such as hemophilia patients, coagulation mechanism disorders, thrombocytopenia, etc; Currently receiving full dose oral or injection anticoagulant drugs or thrombolytic drugs for therapeutic purposes (allowing prophylactic use of low-dose aspirin, etc.); 16. Arterial thromboembolic events occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), CTCAE grade 3 or above deep vein thrombosis, pulmonary embolism, etc; 17. Symptomatic central nervous system (CNS) metastasis; 18. Have active or recurrent autoimmune diseases; 19. Those who have previous and / or current interstitial lung disease, pneumoconiosis, radiation pneumonitis, and have clinical significance according to the investigator's assessment, as well as those who may interfere with the detection and treatment of suspected drug-related pulmonary toxicity due to serious impairment of lung function; 20. HIV positive patients; Known to have received antituberculosis treatment within one year before receiving study treatment for the first time; Know
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival,PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Disease Control Rate,DCR;Overall Survival,OS;duration of response,DOR;Adverse Events,AE;Time to Response,TTR; | — |
Countries
China
Contacts
Public ContactLi Yawei
The First Affiliated Hospital of Bengbu Medical University
Outcome results
None listed