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Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients (Convince)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Betta Pharmaceuticals Co.,Ltd.
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01719536
First received: October 29, 2012
Last updated: November 10, 2014
Last verified: November 2014
History of Changes
  Purpose

The purpose of this study is to compare icotinib with induction and maintenance chemotherapy in the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients with EGFR mutation.


Condition Intervention Phase
NSCLC
 Drug: Icotinib
Drug: Chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Betta Pharmaceuticals Co.,Ltd.:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    A duration from randomization date to disease progression(as defined by RECIST) or death. If a participant are known to have progressed, the time to progression is defined as the time from the date of randomization to the date of progression. Otherwise, a participant will be censored at the last date they are known not to be progressed.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    Overall Survival is assessed via calculation of the time to death due to any cause. If a participant is known to have died, the time to death is defined as the time from the date of randomization to the date of death. Otherwise, a participant will be censored at the last date they are known to be alive.

  • Objective response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants who achieve complete response or partial response. Either complete response (CR) or partial response (PR) will be evaluated by RECIST, confirmed at least 28 days following the date of the initial response.
Estimated Enrollment: 270
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Icotinib
Icotinib 125mg is administered orally three times per day.
 Drug: Icotinib
Icotinib: 125 mg is administered orally three times per day.
Other Names:
  • BPI-2009
  • Conmana
Active Comparator: Chemotherapy
Patients in this arm will receive pemetrexed/cisplatin for 4 cycles, of who don't progress will receive maintenance treatment with pemetrexed.
 Drug: Chemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Other Name: ALIMTA

Detailed Description:

This study is designed to evaluate the efficacy and safety of icotinib and pemetrexed-based first-line induction and maintenance chemotherapy in advanced lung adenocarcinoma with EGFR-mutation，primary endpoint is progress-free survival，second endpoints include overall survival, time to progression, and so on.

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent or progressive Non-Small Cell Lung Cancer stage IV or IIIB patients.
  • Positive EGFR Mutation.
  • No previous systemic anticancer therapy.
  • Measurable lesion according to RECIST with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
  • Provision of written informed consent.

Exclusion Criteria:

  • Experience of Anti-EGFR(the epidermal growth factor receptor) Monoclonal Antibody or small molecular compounds therapy such as gefitinib, erlotinib or Cetuximab.
  • Evidence of clinically active Interstitial Lung Diseases (Patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
  • Known severe hypersensitivity to icotinib or any of the excipients of this product.
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719536

Contacts
Contact: Shi Yuankai, M.D. 0086-13701251865

  Show 21 Study Locations
Sponsors and Collaborators
Betta Pharmaceuticals Co.,Ltd.
Investigators
Principal Investigator: Shi Yuankai, M.D. Cancer Hospital, Chinese Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01719536     History of Changes
Other Study ID Numbers: BD-IC-IV36
Study First Received: October 29, 2012
Last Updated: November 10, 2014
Health Authority: China: Food and Drug Administration

ClinicalTrials.gov processed this record on February 27, 2015