Efficacy and Safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

NCT04137588 | Unknown

• 1 other identifier: 20191023
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of Use of Platinum Based Doublet Chemotherapy Plus Antiangiogenesis and Immune Checkpoint Inhibitors in Patients With Advanced Non-squamous Non-small Cell Lung Cancer

Conditions

Advanced Non-squamous Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate

  ORR of treatment

  one year

Study Arms (3)

Group A

antiangiogenesis 7.5mg/Kg q3w+pemetrexed 500mg/m2 q3w+ platinum 75mg/m2 q3w

Drug: Antiangiogenesis Agents

Group B

immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w

Drug: Immune checkpoint inhibitor

Group C

antiangiogenesis 7.5mg/Kg q3w+immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w

Drug: Antiangiogenesis Agents; Drug: Immune checkpoint inhibitor

Interventions

Antiangiogenesis Agents DRUG

antiangiogenesis agents plus chemotherapy as first line treatment

Group A; Group C

Immune checkpoint inhibitor DRUG

immune checkpoint inhibitor plus chemotherapy as first line treatment

Group B; Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females, 18-75 years of age, non squamous non-small cell lung cancer, wild type genotype

You may qualify if:

• Voluntarily sign informed consent;
• Non-squamous non-small cell lung cancer, newly diagnosed or previously not treated with systemic chemotherapy and / or epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors treatment;
• Aged 18-75 years;
• Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
• Survival is expected to exceed 12 weeks ;
• Patients had a wild-type genotype (WT population; patients with EGFR or ALK genetic alterations were excluded)

You may not qualify if:

• If any of the following criteria is met, the subject shall be excluded:
• Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
• In the past 2 weeks, there have been systematic anti-tumor treatment including chemotherapy (including thoracic chemotherapy), radiotherapy (excluding radiotherapy of metastatic lesions outside the thoracic radiation field), targeted therapy, immunotherapy and biotherapy;
• The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
• Laboratory results:
• White blood cell count \<3 × 109 / L, neutrophil count \<1.5 × 109 / L, platelet \<75 × 109 / L, or hemoglobin \<8g / dL;
• Coagulation abnormalities (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or activated partial thromboplastin time (APTT) \> 1.5 ULN), with bleeding tendency or being treated with thrombolysis or anticoagulation;
• Serum total bilirubin ≥1.5 ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 ULN in the absence of liver metastases; ALT or AST ≥5 ULN in liver metastases;
• Serum albumin \<30g / L;
• Serum creatinine ≥ 1.5 ULN or creatinine clearance \<40ml / min; • Urine routine urinary protein ≥ ++, or 24 hours urine protein ≥ 1.0 g;
• Heart disease with significant clinical symptoms, such as: congestive heart failure, coronary heart disease with symptom, arrhythmia hardly be controlled by drugs, myocardial infarction in 6 months, or heart failure;
• Imaging (CT or MRI) showed a tumor lesion 5 mm away from the large vessels, or the presence of invasive central vasculature of the central tumor; imaging (CT or MRI) showed significant cavitation or necrosis of the lung tumor; Other diseases that may cause haemoptysis;
• Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax;
• Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more;
• Significant bleeding symptoms or with definite bleeding tendency within 12 months before randomization, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, occult blood ++ and above, intracerebral hemorrhage, vasculitis, or with congenital or acquired coagulopathy disorders;

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Jian Fang

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Angiogenesis Inhibitors; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Growth Inhibitors; Antineoplastic Agents; Therapeutic Uses; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological

Central Study Contacts

Jian Fang, doctor

CONTACT

+86-010-88196469; bcht2_mj@163.com

Jie Zhang, doctor

CONTACT

+86-010-88196478; zhangjie@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: March 3, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

CN (1)