Suspended

Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

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What is being tested

Experimental

+ Chemotherapy

+ Chemotherapy

Drug
Who is being recruted

Carcinoma+2

+ Neoplasms

+ Neoplasms by Histologic Type

From 18 to 70 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorBetta Pharmaceuticals Co., Ltd.
Study ContactJiao Shunchang, MDMore contacts
Last updated: February 8, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib. Primary endpoint: Progression-free survival between first-line icotinib treatment and first-line chemotherapy followed by maintenance with icotinib Secondary endpoint: Overall survival between icotinib and chemotherapy Time to Progression between icotinib and chemotherapy Objective response rate and disease control rate between icotinib and chemotherapy

NCT01665417
Principal SponsorBetta Pharmaceuticals Co., Ltd.
Study ContactJiao Shunchang, MDMore contacts
Last updated: February 8, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialAdenocarcinoma

Criteria

1 inclusion criteria required to participate
Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R)
1 exclusion criteria prevent from participating
Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Icotinib: 125mg, oral administration, three times per day.

Group II

Active Comparator
Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Group III

Active Comparator
Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Chinese People's Liberation Army (PLA) General Hospital

Beijing, ChinaOpen Chinese People's Liberation Army (PLA) General Hospital in Google Maps
SuspendedOne Study Center