Lung cancer
Conditions
Interventions
Pilot group A:Group A: QL-1706: 5 mg/kg, i.v., d1, q3w
bevacizumab: 7.5 mg/kg, i.v., d1, q3w. Maximum duration of treatment with QL-1706 and bevacizumab was 24 months.
Pilot group B:Group B: QL-1706: 5 mg/kg, i.v., d1, q3w
chemotherapy (chemotherapy regimen to be determined by the investigator).Maximum duration of treatment with QL-1706 and chemotherapy was 24 months.
Sponsors
YANCHENG THIRD PEOPLE'S HOSPITAL
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)>= 18 years of age; 2)Eastern Collaborative Oncology Group (ECOG) physical status score of 0-1; 3)Life expectancy of more than 3 months; 4)Histologically or cytologically confirmed diagnosis of stage IV non-squamous non-small cell lung cancer (as judged by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumour Staging Manual, 8th edition); 5)No EGFR-sensitive mutations and no ALK or ROS1 gene rearrangements; 6) Patients with at least one target lesion with a measurable diameter according to the RECIST 1.1 criteria (long diameter of the tumour lesion =10 mm on CT scan, short diameter of the lymph node lesion =15 mm on CT scan, and the thickness of the scanned layer is not more than 5 mm); 7) Prior progression to first-line trans-PD-1 therapy (according to RECIST v1.1). 8) Good major organ function: good haematopoietic function, defined as an absolute neutrophil count = 1.5 × 10^9/L, platelet count = 100 × 10^9/L, and haemoglobin = 90 g/L [no transfusion within 7 days or no erythropoietin (EPO)-dependent]; good hepatic function, defined as a total bilirubin level <= the upper limit of normal (ULN); in patients without liver metastases, the Good liver function, defined as total bilirubin level <= upper limit of normal (ULN); in patients without liver metastases, albumin transaminase (AST) and alanine transaminase (ALT) levels <= 1.5 ULN, alkaline phosphatase <= 2.5 ULN, and, for patients with documented hepatic metastases, AST and ALT levels <= 5 ULN; and good renal function, defined as serum creatinine <= 1.5 times the ULN or calculated creatinine clearance = 60 mL/min (Cockcroft-Gault formula); urine protein less than 2+ on routine urinalysis, or if the patient has = 2+ at baseline levels 24-hour urine should be collected and demonstrated to be <= 1 g on a 24-hour quantitative urine protein test; and good coagulation function defined as an International Normalised Ratio (INR) or prothrombin time ( PT) <= 1.5 ULN; 9) Willingness and ability to comply with study-planned visits, treatment plans, laboratory tests, and other study procedures; 10) For female subjects of childbearing potential, a negative urine or serum pregnancy test should be demonstrated within 3 days prior to receiving the first administration of study drug (Cycle 1, Day 1). If a negative urine pregnancy test result cannot be confirmed, a blood pregnancy test will be requested. If there is a risk of conception, male and female patients will be required to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) for at least 180 days after discontinuation of trial treatment.
Exclusion criteria
Exclusion criteria: 1)Histology is small cell lung cancer, squamous carcinoma; 2) Subjects with prior first-line use of QL1706. 3)Currently participating in an interventional clinical study treatment or have been treated with another investigational drug or with an investigational device within the week prior to the first dose; 4) Hypersensitivity to any component of the study drug; 5) Non-surgically sterilised or fertile female patients must have a negative serum HCG test within 72 hours prior to the first dose and must be non-lactating and need to agree to use appropriate contraception (e.g., IUD, birth control pills or condoms, etc.) for the duration of the study treatment and for 3 months after the end of the study treatment period; male patients agree to use appropriate method of contraception; 6) Active brain metastases (patients with asymptomatic brain metastases may be enrolled); for patients with clinically suspected CNS metastases, CT or MRI examinations must be performed within 28 days prior to enrolment to exclude CNS metastases; 7)Patients with a history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months prior to screening or myocardial infarction events within 6 months prior to screening; arrhythmias (including QTcF: = 450 ms in men and = 470 ms in women) requiring long-term use of anti-arrhythmic drugs and New York Heart Association classification = class II cardiac insufficiency; 8)Urine routine suggesting urinary protein =++ and confirmed 24-hour urine protein quantification > 1.0 g; 9) patients with infectious pneumonia, non-infectious pneumonia, interstitial pneumonia and other patients requiring corticosteroids; history of chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease, such as ulcerative enteritis, Crohn's disease and chronic diarrhoeal diseases, such as irritable bowel syndrome; history of tuberculosis or tuberculosis; and history of active hepatitis B, hepatitis C, and patients with HIV infection [If hepatitis B virus (HBV) infection, e.g., HBsAg-positive, HBV-DNA testing is required and HBV-DNA needs to be 10-fold (1 lg) reduction in viral copy number compared to pre-treatment. For HBV-infected patients, antiviral therapy was required throughout the study period. Hepatitis C virus (HCV)-RNA positive subjects must receive antiviral therapy according to treatment guidelines]; 10)Patients with hypersensitivity to human or murine monoclonal antibodies; 11)Those with a history of psychotropic substance abuse that cannot be abstained from or those with psychiatric disorders; 12)Pleural effusions or abdominal effusions with clinical symptoms requiring clinical intervention; 13) concomitant illnesses that, in the judgement of the investigator, seriously jeopardise the safety of the patient or interfere with the patient's ability to complete the study; 14) other conditions that, in the judgement of the investigator, are not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective mitigation rate;Overall survival;Disease control rate; | — |
Countries
China
Contacts
Public ContactHonggang Cao
YANCHENG THIRD PEOPLE'S HOSPITAL
Outcome results
None listed