NCT01665417

Brief Summary

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

4.9 years

First QC Date

August 12, 2012

Last Update Submit

February 7, 2017

Conditions

EGFR Positive Non-small Cell Lung CancerAdenocarcinoma

Keywords

IcotinibEGFR positive mutationFirst-line treatmentMaintenance treatment

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

    8 months

Secondary Outcomes (4)

  • Overall survival

    24 months

  • Time to Tumor Progression

    8 months

  • Objective response rate

    3 months

  • Number of participants with adverse events

    24 months

Study Arms (3)

Experimental Icotinib

EXPERIMENTAL

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

Drug: Experimental

Chemotherapy Regimen 1

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.

Drug: Chemotherapy

Chemotherapy Regimen 2

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.

Drug: Chemotherapy

Interventions

ExperimentalDRUG

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

Also known as: BPI-2009, Commana
Experimental Icotinib
ChemotherapyDRUG

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.

Also known as: Pemetrexe, ALIMTA
Chemotherapy Regimen 1Chemotherapy Regimen 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese People's Liberation Army (PLA) General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Drug TherapyPemetrexedDocetaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Jiao Shunchang, MD

    Chinese People's Liberation Army (PLA) General Hospital

    PRINCIPAL INVESTIGATOR

  • Fang Jian, MD

    Peking University Cancer Hospital & Institute

    STUDY DIRECTOR

  • Bai Chunmei, MD

    Peking Union Medical College Hospital

    STUDY DIRECTOR

  • Liu Wei, MD

    Hebei Provincal Tumor Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiao Shunchang, MD

CONTACT

0086-13801380677

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2012

First Posted

August 15, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

February 8, 2017

Record last verified: 2017-02

Locations

CN(1)