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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Apatinib
Pemetrexed
Carboplatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apatinib

Control

Arm Description

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.

Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).

Outcomes

Primary Outcome Measures

Overall survival
Overall survival was assessed from randomization to death as a result of any cause.

Secondary Outcome Measures

Disease-free survival
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Number of Participants with Adverse Events
To assess if the addition of apatinib to chemotherapy is safe.

Full Information

First Posted
May 22, 2017
Last Updated
July 27, 2018
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03164694
Brief Title
APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC
Acronym
APPEAL
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
May 20, 2019 (Anticipated)
Study Completion Date
May 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apatinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients were given pemetrexed (500 mg/m2) plus carboplatin (AUC =5).
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib was given 850 mg per day orally.
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
pemetrexed (500 mg/m2)
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin (AUC =5)
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival was assessed from randomization to death as a result of any cause.
Time Frame
1 year after the last patient is randomized
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
Disease-free survival was assessed from randomization to disease recurrence or death as a result of any cause.
Time Frame
1 year after the last patient is randomized
Title
Number of Participants with Adverse Events
Description
To assess if the addition of apatinib to chemotherapy is safe.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Si-Yu Wang, MD
Phone
+86 20 87343439
Email
wsysums@163.net
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si-Yu Wang, Doctor
Phone
+86 20 87343439
Email
wsysums@163.net

12. IPD Sharing Statement

Learn more about this trial

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

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