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Status unknownNCT02140333Updated Feb 12, 2015

Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC

A Phase 3 interventional study of Erlotinib in NSCLC and EGFR Mutation, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Read the detailed description

In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.

02

Conditions studied

  • NSCLC
  • EGFR Mutation

Keywords

  • erlotinib
  • EGFR mutation
03

In context

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 165 studies on the registry; 67 are open to participants now.

Browse The First Affiliated Hospital of Guangzhou Medical University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histological diagnosis of NSCLC with phase IIIB or IV disease;
  2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
  3. Never received anti-tumor therapies for the advanced stage;
  4. Never used EGFR inhibitors;
  5. Measurable disease by RECIST criteria;
  6. Male or female patients >=18 years of age;
  7. ECOG karnofsky performance 0\~3, life expectancy is greater than 12 weeks;
  8. Patients must be accessible for treatment and follow-up;

Exclusion criteria

Exclusion Criteria:

  1. Previously used EGFR inhibitors
  2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
  3. Allergic to erlotinib;
  4. Non-measurable lesions
  5. Pregnant or lactating women;
  6. Patients having other factors that preventing researchers from enrollment them.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    Erlotinib 100mg

    Erlotinib 100mg

    Drug: Erlotinib

  • Active comparator
    Erlotinib 150mg

    Erlotinib 150mg

    Drug: Erlotinib

Interventions

  • DrugErlotinib

    100mg vs. 150mg

    Also known as: tarceva

06

What researchers measure

Primary outcomes

  1. Progression free survival

    Time frame: 2 years after the initial dose

Secondary outcomes

  1. The objective response rate

    Time frame: Patients will be followed for an expected average of 6 months

Other outcomes

  1. Overall survival

    Time frame: 3 year after the initial dose

  2. Adverse events

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Guangzhou medical university
    Guanzhou, Guangdong 510120, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2013, a primary completion of Aug 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 5, 2013
First posted
May 16, 2014
Start
Aug 2013
Primary completionEst.
Aug 2018
CompletionEst.
Dec 2018
Last update
Feb 12, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02140333
Lead sponsor
The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Jianxing He (The First Affiliated Hospital of Guangzhou Medical Univers, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
May 16, 2014
Start date
Aug 2013
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Feb 12, 2015

Study contacts

jianxing He, PhD
Contact
drjianxing.he@gmail.com
86-20-83062821
yalei zhang, Dr.
Contact
yayazhang2004@163.com
86-20-83062821

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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