AzTrials
AzTrials

Nonsmall Cell Lung CancerPhase 2NCT03256721

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

A Phase 2 study testing Apatinib/docetaxel/pemetrexed and docetaxel/pemetrexed in people with Nonsmall Cell Lung Cancer, run by Fuzhou General Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Nonsmall Cell Lung Cancer
What is being tested?
Apatinib/docetaxel/pemetrexed and docetaxel/pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
16 Aug 2017to 16 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Small Cell Lung Cancer;
  • Subjects with symptomatic brain metastases;
  • Survival expectation < 3 months;
  • Blood transfusion is required in the first dose of drug treatment within 14 days ;
  • 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);
  • The risk of active bleeding;
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  • Subjects with uncontrolled blood pressure with medication (140/90 mmHg)
  • Laboratory values and organ functions ： （1）Hematologic insufficiency:
  • Hemoglobin (Hb)<8.5 g/dL，
  • Absolute neutrophil count (ANC)≤1.5×109/L，
  • Platelet count (PLT)< 100×109/L； （2）Insufficient liver function:
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  • Bilirubin > 1.5×the upper limit of normal (ULN)
  • Alanine aminotransferase (ALT), or Aspartate aminotransferase (AST) >3.0×(ULN), When liver metastases,Bilirubin > 1.5×ULN, ALT or AST >5.0×(ULN.
  • 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
  • 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,
  • Subjects with liver fibrosis or hepatic cirrhosis
  • (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,
  • Subjects with major surgery in the first dose of drug treatment within 28 days,
  • Subjects with positive foknown human immunodeficiency virus。

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fuzhou general hospital

    Fuzhou, Fujian, 365000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Apatinib/docetaxel/pemetrexed, docetaxel/pemetrexed
Keywords
apatinib docetaxel pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apatinib/docetaxel/pemetrexedDrug

    Participants are randomly assigned to treatment group or control group

  • docetaxel/pemetrexedDrug

    Participants are randomly assigned to treatment group or control group

Study groups in NCT03256721
Study groupRoleWhat they receive
Apatinib+docetaxel/pemetrexedExperimentalApatinib 500mg QD PO d1-21+docetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
Receives: Drug: Apatinib/docetaxel/pemetrexed
docetaxel/pemetrexedActive comparatordocetaxel(75mg/m2 IV d1)/pemetrexed(500 mg/m2 IV d1),q21d
Receives: Drug: docetaxel/pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    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)

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start16 Aug 2017
  3. Primary completion27 Mar 2019
  4. Study completion16 Aug 2019

Why it stopped: Due to the enrollment was slow and exceeded the expected enrollment time

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A: Apatinib 500mg QD PO d1-21 + Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d Group B: Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03256721
Sponsor's protocol ID
SECGOLC003
Status last verified
Aug 2018
First submitted
16 Aug 2017
Last updated
8 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yu Z, Cai X, Xu Z, He Z, Lai J, Wang W, Zhang J, Kong W, Huang X, Chen Y, Shi Y, Shi X, Zhao Z, Ni M, Lin X, Chen S, Wu X, Chen W, Song Z, Huang C. Apatinib plus Chemotherapy as a Second-Line Treatment in Unresectable Non-Small Cell Lung Carcinoma: A Randomized, Controlled, Multicenter Clinical Trial. Oncologist. 2020 Nov;25(11):e1640-e1649. doi: 10.1634/theoncologist.2020-0519. Epub 2020 Jul 25.

    PubMed 32533785

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apatinib/docetaxel/pemetrexed and docetaxel/pemetrexed in people with Nonsmall Cell Lung Cancer, run by Fuzhou General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the enrollment was slow and exceeded the expected enrollment time). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03256721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.

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