Endostar/PD-1 Inhibitors Combined With PP for Advanced NSCLC

NCT04063449 | Unknown

• 1 other identifier: ThirdMMU09
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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

Conditions

Non-squamous Non-small Cell Lung Cancer

Keywords

Non-squamous NSCLC；endostar;PD-1 inhibitor;chemotherapy

Outcome Measures

Primary Outcomes (2)

• progression-free survival(PFS)

  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)

  overall survival is defined as the time from randomization to death from any cause

  approximately 36 months

Secondary Outcomes (2)

• objective response rate(ORR)

  approximately 18 months

• adverse event(AE)

  approximately 36 months

Study Arms (2)

Experimental:group A

EXPERIMENTAL

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

control:group B

ACTIVE COMPARATOR

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

Interventions

endostar/PD-1 inhibitor DRUG

Antiangiogenic therapy plus immunotherapy and chemotherapy

Experimental:group A

endostar DRUG

Antiangiogenic therapy plus chemotherapy

control:group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dong Wang: lead

Study Sites (1)

Daping Hospital, Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Interventions

endostar protein

Study Officials

• Dong Wang, PH.D

  Daping Hospital, Third Military Medical University, Chongqing,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, PH.D

CONTACT

86-23-68757181; dongwang64@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: August 20, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

CN (1)