AzTrials
AzTrials

Non-Small-Cell Lung CancerNCT02148380

Combination of Chemotherapy and Gefitinib as First-line Treatment

A study testing pemetrexed plus carboplatin and gefitinib in people with Non-Small-Cell Lung Cancer, run by Baohui Han at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-Small-Cell Lung Cancer
What is being tested?
pemetrexed plus carboplatin and gefitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
1 siteChina
Study dates
May 2014to Dec 2015
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age >=18 years
  • Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
  • A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
  • Measurable or non-measurable disease
  • Able to comply with study and follow-up procedures

Who cannot join

  • Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
  • Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer
  • Symptomatic or untreated brain metastases
  • Prior systemic chemotherapy for NSCLC
  • Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
  • History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
  • Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
  • Pregnancy or lactation

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Chest Hospital

    Shanghai, 200030

Other trials in China

About this study

Official title: Combination of Chemotherapy and Gefitinib as First-line Treatment of Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomised Controlled Trial

The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.

Being tested
pemetrexed plus carboplatin, gefitinib
Keywords
Lung adenocarcinoma,EGFR mutation, chemotherapy, gefitinib
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.

  • pemetrexed plus carboplatinDrug

    Also called Alimita plus carboplatin

  • gefitinibDrug

    Also called Iressa

Study groups in NCT02148380
Study groupRoleWhat they receive
chemotherapy group(B)Experimentalpemetrexed plus carboplatin pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) every 4 weeks for up to six cycles, then continued to receive pemetrexed(500 mg/m(2) on day 1) alone every 4 weeks
Receives: Drug: pemetrexed plus carboplatin
combination therapy group(A)Experimentalpemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5-21) and repeated every 4 weeks for up to six cycles,then continued to receive pemetrexed combined with gefitinib every 4 weeks.
Receives: Drug: pemetrexed plus carboplatin; Drug: gefitinib
gefitinib group (group C)Experimentalreceived gefitinib( 250 mg/day)alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death
Receives: Drug: gefitinib

What is being measured

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

  1. progression-free survival

    Measured: 6-month

Secondary outcomes (2)

  1. overall survival

    Measured: 2 years

  2. to evaluate the safety profile between three groups

    Toxicity will be graded according to NCI CTCAE, version 4.0. The analysis of safety/tolerability data will be descriptive; toxicity events will be individually tabulated.

    Measured: 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 posted28 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2014
  4. Study completionDec 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02148380
Sponsor's protocol ID
chest20140001
Status last verified
Apr 2016
First submitted
21 May 2014
Last updated
20 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Lou Y, Xu J, Zhang Y, Lu J, Chu T, Zhang X, Wang H, Zhong H, Zhang W, Han B. Chemotherapy Plus EGFR-TKI as First-Line Treatment Provides Better Survival for Advanced EGFR-Positive Lung Adenocarcinoma Patients: Updated Data and Exploratory In Vitro Study. Target Oncol. 2020 Apr;15(2):175-184. doi: 10.1007/s11523-020-00708-y.

    PubMed 32170554

Questions about this trial

What is this clinical trial studying?

A study testing pemetrexed plus carboplatin and gefitinib in people with Non-Small-Cell Lung Cancer, run by Baohui Han 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 20 Apr 2016. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 6-month). 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 NCT02148380, 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 20 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in