Endostar/PD-1 Inhibitors Combined With PP for Advanced NSCLC
Study Details
Study Description
Brief Summary
A Controlled Clinical Study of Endostar/PD-1 Inhibitors Combined With chemotherapy(Carboplatin-Pemetrexed) as First-line Treatment for Advanced Non-squamous Cell Lung Cancer With Negative Driving Gene
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This study was a controlled clinical trial.A total of 170 patients with pathologically confirmed non-squamous NSCLC would be enrolled.Patients were randomly divided into two groups, with 85 in the group A and 85 in the group B.The group A was treated with endostar,sintilimab and chemotherapy(carboplatin-pemetrexed).The group B was treated with endostar and chemotherapy(carboplatin-pemetrexed).The efficacy and safety would be evaluated.The progression-free survival and overall survival would be analyzed.This data of this study might provide a more effective treatment for non-squamous NSCLC.
Study Design
Arms and Interventions
| 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 ; |
Drug: endostar/PD-1 inhibitor
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 ; |
Drug: endostar
Antiangiogenic therapy plus chemotherapy
|
Outcome Measures
Primary Outcome Measures
- progression-free survival(PFS) [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
- overall survival (OS) [approximately 36 months]
overall survival is defined as the time from randomization to death from any cause
Secondary Outcome Measures
- objective response rate(ORR) [approximately 18 months]
complete response(CR)+partial response(PR) according to RECIST 1.1
- adverse event(AE) [approximately 36 months]
adverse event according to NCI CTCAE V4.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients volunteered to participate in the study and signed the informed consent;
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Age 18-75, both male and female;
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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.
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At least one measurable lesion according to RECIST 1.1,which should not be treated locally, such as radiotherapy.
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ECOG PS 0-1
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Expected survival ≥ 3 months
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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.
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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:
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Severe allergic reactions to humanized antibodies or fusion proteins in the past
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known to have hypersensitivity to any component contained in Endostar or antibody preparations;
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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);
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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.
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Serious heart disease, include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, and severe valvular disease.
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Patients treated targeted drugs such as bevacizumab, sunitinib, sorafenib, imatinib, famitinib, regiffenil, apatinib and anlotinib
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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
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Positive hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab), indicating acute or chronic infection.
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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.
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Patients with brain metastases with symptoms or symptoms controlling less than 2 months
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Major surgical treatment, incision biopsy or significant traumatic injury were performed within 28 days before the grouping.
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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.
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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
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Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism.
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The study is dangerous for patients judged by researcher, or patients who may affect the completion of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Daping Hospital, Third Military Medical University | Chongqing | Chongqing | China | 400042 |
Sponsors and Collaborators
- Dong Wang
Investigators
- Principal Investigator: Dong Wang, PH.D, Daping Hospital, Third Military Medical University, Chongqing,China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ThirdMMU09