Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in NSCLC

February 3, 2021 updated by: Fuzhou General Hospital

A Randomized, Parallel Control, Exploratory Trial to Compare Apatinib Plus Chemotherapy Drug Versus Chemotherapy Drug as Second-line Treatment in Subjects With Advanced or Metastatic of the Non-small Cell Lung Cancer (NSCLC)

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Lung cancer is the leading cause of cancer death in world wild, especially non-small cell lung cancer (NSCLC). Detection and early intervention are difficult because pathogenesis of NSCLC is not yet entirely clear.Most of them are advanced or metastatic patients, so approach 3/4 NSCLC undergo chemotherapy. Fewer treatment options exist on NSCLC whom is wild type of EGFR. The patient did not benefit from the existing treatment regimen after first-line treatment. There is currently no effective drug to treat this group of patients.

Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus chemotherapy drug can improve progression free survival compared with chemotherapy drug in patients with metastatic the non-small cell lung cancer who failed one lines of chemotherapy.

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 365000
        • Fuzhou General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age：18~75 years;
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  3. Subjects with histologically or cytologically confirmed locally advanced or advanced NSCLC who have previously received no more than one lines treatment before participating；
  4. Subjects with at least one measurable lesion as defined by RECIST (version 1.1),which is confirmed by computed tomography (CT) scan or MRI .
  5. EGFRˉ,and ALK mutation in the negative or unknown；
  6. Subjects without brain metastases or asymptomatic brain metastases, and not needing for dehydrating agents or corticosteroids to control intracranial symptoms;
  7. Survival expectation≥ 3 months;
  8. The main organ function is normal;
  9. Females of childbearing potential must be a pregnancy test in 7 days before participating ( including serum or urine), and the results were negative.
  10. Subjects provided written informed consent before participating,Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

  1. Small Cell Lung Cancer;
  2. Subjects with symptomatic brain metastases;
  3. Survival expectation < 3 months;
  4. Blood transfusion is required in the first dose of drug treatment within 14 days ;
  5. The interval of subjects had received chemotherapy, biotherapy, radiotherapy or other anticancer therapies in the first dose of drug treatment within 21 days(excluding palliative radiotherapy);
  6. The risk of active bleeding;
  7. Subjects with uncontrolled blood pressure with medication (140/90 mmHg)

  8. Laboratory values and organ functions ： （1）Hematologic insufficiency:

    1. Hemoglobin (Hb)<8.5 g/dL，
    2. Absolute neutrophil count (ANC)≤1.5×109/L，
    3. Platelet count (PLT)< 100×109/L； （2）Insufficient liver function:
    1. Bilirubin > 1.5×the upper limit of normal (ULN)
    2. Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN), When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.
    3. serum creatinine ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula) (3) Subjects with positive for HBV surfaceantigen ( HBsAg)or anti-hcv (4)Subjects with Interstitial lung disease (5)Insufficient renal function: serum creatinine≥ 1.5×（ULN）, or creatinine clearance <60 mL/min
  9. impairment of heart function: (1)Left ventricular ejection fraction (LVEF) <45% (LVEF evaluation is not required for subjects have no history of congestive heart failure), (2)Unstable angina, (3)Severe arrhythmia, (4)NYHA III or IVgrade of congestive heart failure, (5) Subjects with miocardial infarction within the last 12 months before entering the trial, (6)Pericardial effusion,
  10. Subjects with liver fibrosis or hepatic cirrhosis
  11. (1)Subjects with other active malignancy (except for definitively treated non melanoma skin cancer,carcinoma in-situ of the cervix,or other cancers that are treated with curative treatment and have no signs of recurrence for at least 5 years ) , (2)Subjects with dysphagia,malabsorption,chronic gastrointestinal diseases,or other medical history may hinder compliance and / or experimental drug absorption,
  12. Subjects with major surgery in the first dose of drug treatment within 28 days,
  13. Subjects with positive foknown human immunodeficiency virus。

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Apatinib+docetaxel/pemetrexed
Apatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
Drug: Apatinib/docetaxel/pemetrexed
Participants are randomly assigned to treatment group or control group
ACTIVE_COMPARATOR: docetaxel/pemetrexed
docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
Drug: docetaxel/pemetrexed
Participants are randomly assigned to treatment group or control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
To compare progression-free survival (PFS) in subjects treated with apatinib plus chemotherapy drug versus chemotherapy drug as a second-line treatment in whom with advanced or metastatic non-small cell lung cancer (NSCLC)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuzhou General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 16, 2017

Primary Completion (ACTUAL)

March 27, 2019

Study Completion (ACTUAL)

August 16, 2019

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 20, 2017

First Posted (ACTUAL)

August 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SECGOLC003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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