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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04137588
Recruitment Status : Recruiting
First Posted : October 24, 2019
Last Update Posted : October 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Fang, Beijing Cancer Hospital

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

Condition or disease Intervention/treatment
Advanced Non-squamous Non-small Cell Lung Cancer Drug: Antiangiogenesis Agents Drug: Immune checkpoint inhibitor

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: A Prospective of 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
Estimated Study Start Date : October 22, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Group/Cohort Intervention/treatment
Group A
antiangiogenesis 7.5mg/Kg q3w+pemetrexed 500mg/m2 q3w+ platinum 75mg/m2 q3w
Drug: Antiangiogenesis Agents
antiangiogenesis agents plus chemotherapy as first line treatment

Group B
immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w
Drug: Immune checkpoint inhibitor
immune checkpoint inhibitor plus chemotherapy as first line treatment

Group C
antiangiogenesis 7.5mg/Kg q3w+immune checkpoint inhibitors 200mg q3w+pemetrexed 500mg/m2 q3w+platinum 75mg/m2 q3w
Drug: Antiangiogenesis Agents
antiangiogenesis agents plus chemotherapy as first line treatment

Drug: Immune checkpoint inhibitor
immune checkpoint inhibitor plus chemotherapy as first line treatment




Primary Outcome Measures :
  1. objective response rate [ Time Frame: one year ]
    ORR of treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Males and females, 18-75 years of age, non squamous non-small cell lung cancer, wild type genotype
Criteria

Inclusion Criteria:

  1. Voluntarily sign informed consent;
  2. 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;
  3. Aged 18-75 years;
  4. Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
  5. Survival is expected to exceed 12 weeks ;
  6. Patients had a wild-type genotype (WT population; patients with EGFR or ALK genetic alterations were excluded)

Exclusion Criteria:

If any of the following criteria is met, the subject shall be excluded:

  1. Squamous cell carcinoma (including adenosquamous carcinoma) and small cell lung cancer (including small cell carcinoma and non-small cell mixed lung cancer);
  2. 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;
  3. The subject had received anti-vascular endothelial growth factor (VEGF) small molecule tyrosine kinase inhibitors or monoclonal antibodies in the past 4 weeks;
  4. 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;
  5. 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;
  6. 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;
  7. Imaging (CT or chest radiograph) showed significant pneumothorax, fluid pneumothorax;
  8. Obvious cough blood in 6 months, or daily hemoptysis amounted to half a teaspoon (2.5ml) or more;
  9. 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;
  10. Thrombosis, cancer thrombosis (including arteriovenous thrombosis, tumor thrombus, pulmonary embolism, transient ischemic attack, etc.) occurred within 12 months;
  11. There are gastrointestinal obstruction, peptic ulcer, Crohn's disease, ulcerative colitis and other gastrointestinal diseases or other diseases may cause gastrointestinal bleeding or perforation;
  12. Severe respiratory diseases, or need long-term oxygen, corticosteroid treatment of diseases such as chronic obstructive pulmonary disease, interstitial lung disease and respiratory failure;
  13. Patients with uncontrolled central nervous system metastasis;
  14. There are serious uncontrolled systemic diseases, such as nephrotic syndrome, infection, poorly controlled diabetes;
  15. Patients with active HIV(human immunodeficiency virus), HBV(hepatitis B virus), or HCV(hepatitis C virus) infection;
  16. Patients had undergone surgery (<28 days) or did not heal completely, or had other unhealed wounds before the study;
  17. Patients known to be allergic to bevacizumab or any of the components of the drug;
  18. Pregnant or lactating female patients, or unwilling to take contraceptive measures of reproductive age patients (including men);
  19. There is a serious psychological or mental abnormality, or lack of compliance;
  20. The investigator determines other circumstances that may affect the conduct of clinical studies and the determination of findings;
  21. Participants with an active, known or suspected autoimmune disease;
  22. Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first treatment;
  23. Participants with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug related pulmonary toxicity.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04137588


Contacts
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Contact: Jian Fang, doctor +86-010-88196469 bcht2_mj@163.com
Contact: Jie Zhang, doctor +86-010-88196478 zhangjie@bjmu.edu.cn

Locations
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China, Beijing
Jian Fang Recruiting
Beijing, Beijing, China, 100142
Contact: Jian Fang    +86-010-88196469    bcht2_mj@163.com   
Contact: Jie Zhang    +86-010-88196478    zhangjie@bjmu.edu.cn   
Sponsors and Collaborators
Beijing Cancer Hospital

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Responsible Party: Jian Fang, Thoracic Oncology II Department, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT04137588    
Other Study ID Numbers: 20191023
First Posted: October 24, 2019    Key Record Dates
Last Update Posted: October 24, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents