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Status unknownNCT02283424Updated Nov 5, 2014

Icotinib as the Adjunctive Treatment After Surgery in Stage I-IIIB Lung Adenocarcinoma Patients With EGFR Gene Mutation

A Phase 4 interventional study of Icotinib and chemotherapy (Carboplatin and Docetaxel) in Neoplasms, Therapy-Associated, sponsored by Chinese PLA General Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-11-05.

Sponsored by Chinese PLA General Hospital · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2014), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the detailed description

In this trial the investigators will enlist 100 patients who accepted surgery and with epidermal growth factor receptor gene mutation,these patients will be divided into 2 groups (chemotherapy group and Icotinib group),compare the PFS,RFS,OS after 5 years follow up

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Conditions studied

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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 10 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-75 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

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
10 participants (estimated)

Study arms

  • Active comparator
    chemotherapy

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

    Drug: Icotinib · Drug: chemotherapy (Carboplatin and Docetaxel)

  • Experimental
    Icotinib

    Icotinib, 125mg,3/D,2years

    Drug: Icotinib · Drug: chemotherapy (Carboplatin and Docetaxel)

Interventions

  • DrugIcotinib

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

    Also known as: Conmana

  • Drugchemotherapy (Carboplatin and Docetaxel)

    as control group,compared with Icotinib

    Also known as: Carboplatin and Docetaxel

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What researchers measure

Primary outcomes

  1. Recurrence-free Survival

    Time frame: 6 months

Secondary outcomes

  1. Overall survival

    Time frame: 6 months

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Study locations

1 site
  • PLA General Hospital
    BeiJing, 100853, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02283424
Lead sponsor
Chinese PLA General Hospital
Responsible party
Yang Liu (M.D., Chinese PLA General Hospital) — Principal investigator
First posted
Nov 5, 2014
Start date
Oct 2014
Primary completion
Oct 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Nov 5, 2014

Study contacts

Yang Liu, doctor
study chair · PLA General Hospital

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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