NCT02283424

Brief Summary

This is a randomized ,opened, prospective controlled trial of clinical effectiveness for Icotinib as the adjunctive treatment after surgery in stage I-IIIB lung adenocarcinoma patients with epidermal growth factor receptor gene mutation

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
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration 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

October 1, 2014

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

3 years

First QC Date

October 30, 2014

Last Update Submit

November 4, 2014

Conditions

Neoplasms, Therapy-Associated

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    6 months

Secondary Outcomes (1)

  • Overall survival

    6 months

Study Arms (2)

chemotherapy

ACTIVE COMPARATOR

Carboplatin,350mg/m2,1/3weeks Docetaxel,75mg/m2,1/3weeks

Drug: IcotinibDrug: chemotherapy (Carboplatin and Docetaxel)

Icotinib

EXPERIMENTAL

Icotinib, 125mg,3/D,2years

Drug: IcotinibDrug: chemotherapy (Carboplatin and Docetaxel)

Interventions

IcotinibDRUG

compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery

Also known as: Conmana
Icotinibchemotherapy
chemotherapy (Carboplatin and Docetaxel)DRUG

as control group,compared with Icotinib

Also known as: Carboplatin and Docetaxel
Icotinibchemotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Lung adenocarcinoma patients with epidermal growth factor receptor gene mutation,stage I-IIIB after surgery
  • The patients' Eastern Cooperative Oncology Group scores are ≤ 0-2

You may not qualify if:

  • Mismatch conditions above
  • Have used other anti-cancer therapy drug before the trial and may influence the outcome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PLA General Hospital

Beijing, 100853, China

Location

MeSH Terms

Conditions

Neoplasms, Second Primary

Interventions

icotinibDrug TherapyCarboplatinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Yang Liu, doctor

    PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 5, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations

CN(1)