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APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC (APPEAL)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03164694
Recruitment Status : Unknown
Verified July 2018 by Si-Yu Wang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : May 24, 2017
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
Si-Yu Wang, Sun Yat-sen University

Brief Summary:
The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Apatinib Drug: Pemetrexed Drug: Carboplatin Phase 2

Detailed Description:
Platinum-based chemotherapy is the recommended therapeutic approach for patients with advanced non-small cell lung cancer (NSCLC) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement. However, the prognosis of advanced NSCLC remains poor. Apatinib is a novel tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2. Apatinib has been proved to be effective and safe in heavily pretreated patients with gastric cancer. This study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Pemetrexed Plus Carboplatin With or Without Apatinib in Patients With Advanced Non-small Cell Lung Cancer Without EGFR Mutation, ALK Gene Rearrangement, and ROS1 Gene Rearrangement
Actual Study Start Date : May 20, 2017
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Apatinib
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5) plus apatinib. Apatinib was given 850 mg per day orally at day one of chemotherapy.
Drug: Apatinib
Apatinib was given 850 mg per day orally.

Drug: Pemetrexed
pemetrexed (500 mg/m2)

Drug: Carboplatin
carboplatin (AUC =5)

Active Comparator: Control
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
Drug: Pemetrexed
pemetrexed (500 mg/m2)

Drug: Carboplatin
carboplatin (AUC =5)




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year after the last patient is randomized ]
    Overall survival was assessed from randomization to death as a result of any cause.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 1 year after the last patient is randomized ]
    Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.

  2. Number of Participants with Adverse Events [ Time Frame: 1 year ]
    To assess if the addition of apatinib to chemotherapy is safe.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Target population is advanced NSCLC (IIIB-IV) without EGFR mutation, ALK gene rearrangement, and ROS1 gene rearrangement.
  • Written informed consent provided.
  • Male and female patients aged ≥18 years, < 75 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Life expectancy ≥12 weeks.
  • Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
  • Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

  • Known severe hypersensitivity to apatinib or any of the excipients of this product.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
  • Patients with prior radiotherapy
  • History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
  • Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
  • Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
  • Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
  • Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over)

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): NCT03164694


Contacts
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Contact: Si-Yu Wang, MD +86 20 87343439 wsysums@163.net

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Si-Yu Wang, Doctor    +86 20 87343439    wsysums@163.net   
Sponsors and Collaborators
Sun Yat-sen University
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Responsible Party: Si-Yu Wang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03164694    
Other Study ID Numbers: GASTO1006
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

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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
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Pemetrexed
Apatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors