- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04063449
Endostar/PD-1 Inhibitors Combined With PP for Advanced NSCLC
A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With PP as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Recruiting
- Daping Hospital, Third Military Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients volunteered to participate in the study and signed the informed consent;
- Age 18-75, both male and female;
- Histologically or cytologically confirmed advanced or metastatic (stage III B, III C or IV) non-squamous NSCLC , and no mutation was detected in the driving gene.
- At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
- ECOG PS 0-1
- Expected survival ≥ 3 months
- Patients who never received systemic therapy in the past, including radiotherapy ,chemotherapy, targeted therapy and immunotherapy , or patients who relapsed more than 6 months after adjuvant chemotherapy.
- The main organ functions accorded with the following criteria within 7 days before treatment:
(1)Blood routine examination ( without blood transfusion in 14 days): hemoglobin (HB) ≥ 90 g/L; neutrophil absolute value (ANC) ≥ 1.5 *109/L; platelet (PLT) ≥80 *109/L.
(2) Biochemical tests should meet the following criteria: 1) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); 2) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 *ULN, if accompanied by liver metastasis, ALT and AST ≤ 5* ULN; 3) serum creatinine (Cr) ≤ 1.5* ULN or creatinine clearance rate (CCr) ≥ 60 ml/min;4) Serum albumin (≥35g/L).
(3) Doppler echocardiography: left ventricular ejection fraction (LVEF) ≥the low limit of normal value (50%).
9 Tissue samples should be provided for biomarker analysis (such as PD-L1 ) Patients who could not provide new tissues could provide 5-8 paraffin sections of 3-5 μm by archival preservation.
Exclusion Criteria:
- Severe allergic reactions to humanized antibodies or fusion proteins in the past
- known to have hypersensitivity to any component contained in Endostar or antibody preparations;
- Diagnosed of immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 14 days before the study, allowing physiological doses of glucocorticoids (≤10 mg/day prednisone or equivalent);
- Patients with active, known or suspected autoimmune diseases. Patients with type I diabetes, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (such as vitiligo, psoriasis or alopecia). Patients who would not triggers can be included.
- Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
- Patients treated targeted drugs such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regiffenil, apatinib and anlotinib
- Patients recieved systemic antineoplastic therapy, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or mitomycin C within 6 weeks before the grouping),recieved over-extended-field radiotherapy (EF-RT) within 4 weeks before the grouping or limited-field radiotherapy to evaluate the tumor lesions within 2 weeks before the grouping
- Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
- Patients with active pulmonary tuberculosis (TB) infection judged by chest X-ray examination, sputum examination and clinical physical examination. Patients with active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; Patients with active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously were appropriate.
- Patients with brain metastases with symptoms or symptoms controlling less than 2 months
- Major surgical treatment, incision biopsy or significant traumatic injury were performed within 28 days before the grouping.
- The imaging showed that the tumors had invaded important blood vessels or likely to invade important blood vessels and cause fatal massive hemorrhage during the follow-up period judged by researchers.
- patients with any physical signs or history of bleeding; Patients with any bleeding or bleeding events ≥ CTCAE grade 3,unhealed wounds, ulcers or fractures within 4 weeks before grouping
- Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism.
- The study is dangerous for patients judged by researcher, or patients who may affect the completion of the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental:group A
endostar,210 mg,CIV 72h,d1-d3; sintilimab,200mg,IV,d1; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1; 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar plus sintilimab for maintenance therapy until PD or intolerable toxicity ;
|
Antiangiogenic therapy plus immunotherapy and chemotherapy
|
Active Comparator: control:group B
endostar,210 mg,CIV 72h,d1-d3; carboplatin,5/AUC,IV,d1; Pemetrexed,500mg/m2 ,IV,d1; 3 weeks for a cycle;4-6 cycles; after the treatment for 4-6 cycles,endostar for maintenance therapy until PD or intolerable toxicity ;
|
Antiangiogenic therapy plus chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
progression-free survival(PFS)
Time Frame: approximately 36 months
|
progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause
|
approximately 36 months
|
overall survival (OS)
Time Frame: approximately 36 months
|
overall survival is defined as the time from randomization to death from any cause
|
approximately 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
objective response rate(ORR)
Time Frame: approximately 18 months
|
complete response(CR)+partial response(PR) according to RECIST 1.1
|
approximately 18 months
|
adverse event(AE)
Time Frame: approximately 36 months
|
adverse event according to NCI CTCAE V4.0
|
approximately 36 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dong Wang, PH.D, Daping Hospital, Third Military Medical University, Chongqing,China
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Immune Checkpoint Inhibitors
- Endostar protein
Other Study ID Numbers
- ThirdMMU09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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