AzTrials
AzTrials

Advanced Stage Non Small Cell Lung CancerPhase 2NSCLC EGFR TKINCT01955421

Erlotinib 100mg qd Versus Gefitinib 250mg qd for EGFR Mutant Nsclc

A Phase 2 study testing Erlotinib 100mg qd and Gefitinib 250mg qd in people with Advanced Stage Non Small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Erlotinib 100mg qd and Gefitinib 250mg qd
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
Jul 2013to Jun 2016
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of advanced stage NSCLC (stage IIIB or IV) which is confirmed by histology or cytology methods.
  • Harboring a PCR-confirmed activating mutation of EGFR, including an exon 19 deletion or an exon 21 L858R point mutation.
  • Measurable disease according to RECIST1.1.
  • Eastern Cooperative Oncology Group (ECOG) score of 0-2
  • Adequate organ function, defined as all of the following:
  • LVEF >50% or within institution normal values.
Show all 15Show fewer
  • Absolute neutrophil count (ANC)>1500/mm3.
  • Platelet count >75,000/mm3
  • Estimated creatinine clearance>45m1/min.
  • Total bilirubin<1.5 times institutional ULN (Patients with Gilbert's Syndrome total bilirubin must be <4 times institutional ULN).
  • Aspartate amino transferase (AST) or alanine amino transferase (ALT) < three times the institutional upper limit of normal (ULN) (if related to liver metastases<five times institutional ULN).
  • Recovered from any previous therapy related toxicity to ≤CTCAE Grade 1 at study entry (except for stable sensory neurupethy ≤CTCAE Grade 2 and alopecia).
  • Ability to take oral medication in the opinion of the investigator.
  • Age ≥ 18 years.
  • Written informed consent that is consistent with ICH-GCP guidelines.

Who cannot join

  • Prior treatment with EGFR directed small molecules or antibodies.
  • Radiotherapy within 4 weeks prior to randomization, except as follows:
  • Palliative radiation to target organs other than chest may be allowed up to 2 weeks prior to randomization
  • Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
  • Active brain metastases (stable for <4 weeks, symptomatic, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least 4 weeks before randomization.
  • Any other current malignancy or malignancy diagnosed within the past three (3) years (other than basal-cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer).
Show all 20Show fewer
  • Known pre-existing interstitial lung disease.
  • Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade >2 diarrhoea of any aetiology, based on investigator assessment.
  • History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3 (Refer to Appendix 10.4), unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to randomisation.
  • Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug.
  • Women of child-bearing potential and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 2 months after treatment has ended. Adequate methods of contraception and women of Child-Beanng Potenial are discussed in Section 4.2.2.3.
  • Female patients of childbearing potential (see Section 4.2.2.3) who are nursing or are pregnant.
  • Patients unable to complv with the protocol in the opinion of the investigator.
  • Active hepatitis B infection (detined as presence of Hepatitis B DNA), active hepatitis C infection (defined as vresence of Hepatitis C RNA) and/or known HIV carrier.
  • Known or suspected active drug or alcohol abuse in the opinion of the investigator.
  • Requirement for treatment with any of the prohibited concomitant medications listed in Section 4.2.3.
  • Any contraindications for therapy with gefitinib or erlotinib.
  • Known hypersensitivity to erlotinib, gefitinib or the exipients of any of the trial drugs
  • Major surgery within 4 weeks of starting study treatment.
  • Use of any investigational drug within 4 weeks of randomisation (unless a longer time period is required by local regulations or by the guidelines for the investigational product).

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Department of Medical Oncology, Cancer Center of Sun Yat-Sen University

    Guangzhou, Guangdong, 510060

    Wenhua Liang, MD, 8613710249454, liangwh@sysucc.org.cn

    Li Zhang, MD

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label Phase II Trial of Erlotinib 100mg Daily Versus Gefitinib 250mg Daily in Patients With Advanced Non-small Cell Lung Cancer Who Harbor EGFR Mutations.

This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression. Independent assessment of the major endpoints will be completed in a treatment-blinded manner. Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs. second-line therapy). Tumor response and progression will be assessed according to RECIST 1.1.

Being tested
Erlotinib 100mg qd, Gefitinib 250mg qd
Keywords
NSCLC, stage IIIB, stage IV), confirmed by histology or cytology methods, Harboring a PCR-confirmed activating mutation of EGFR, including an exon 19 deletion or an exon 21 L858R point mutation

What participants receive

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

  • Erlotinib 100mg qdDrug

  • Gefitinib 250mg qdDrug

Study groups in NCT01955421
Study groupRoleWhat they receive
Erlotinib100ExperimentalPatients will be randomized to buy and receive erlotinib 100mg qd.
Receives: Drug: Erlotinib 100mg qd
Gefitinib250ExperimentalPatients will be randomized to buy and receive gefitinib 250mg qd.
Receives: Drug: Gefitinib 250mg qd

What is being measured

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

  1. disease control rate

    Measured: 2 years

Secondary outcomes (2)

  1. progression free survival

    Measured: 2 years

  2. adverse events

    rash, diarrhea, ILD, etc.

    Measured: 2 years

Timeline

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

  1. First posted7 Oct 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionJun 2016 (estimated)

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
Masking
None (open label)
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01955421
Sponsor's protocol ID
E100VG250
Other IDs
Tarceva100vsIressa250
Acronym
NSCLC EGFR TKI
Status last verified
Jul 2015
First submitted
24 Sep 2013
Last updated
3 Jul 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhao S, Zhang Z, Fang W, Zhang Y, Zhang Z, Hong S, Ma Y, Zhou T, Yang Y, Huang Y, Zhao H, Zhang L. Efficacy and Tolerability of Erlotinib 100 mg/d vs. Gefitinib 250 mg/d in EGFR-Mutated Advanced Non-small Cell Lung Cancer (E100VG250): An Open-Label, Randomized, Phase 2 Study. Front Oncol. 2020 Nov 10;10:587849. doi: 10.3389/fonc.2020.587849. eCollection 2020.

    PubMed 33244458

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erlotinib 100mg qd and Gefitinib 250mg qd in people with Advanced Stage Non Small Cell Lung Cancer, run by Sun Yat-sen University 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 15 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: status not confirmed, as of the sponsor's last update on 3 Jul 2015. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease control rate (time frame: 2 years). 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 NCT01955421, 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 3 Jul 2015.

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