Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients - Full Text View

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:

Drug Information available for: Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Lung Adenocarcinoma

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:	March 2016
Estimated Primary Completion Date:	December 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 (Adult, Senior)
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

Show 21 Study Locations

Sponsors and Collaborators

Betta Pharmaceuticals Co.,Ltd.

Investigators


Principal Investigator:	Shi Yuankai, M.D.	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

More Information


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:	September 5, 2015
Health Authority:	China: Food and Drug Administration

Additional relevant MeSH terms:


Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pemetrexed	Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 27, 2016

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