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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
NSCLC	Drug: Icotinib; Drug: Chemotherapy	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	296 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
Study Start Date :	December 2012
Estimated Primary Completion Date :	September 2016
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 12 months ]
   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 :

1. Overall survival [ Time Frame: 20 months ]
   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.
2. Objective response rate [ Time Frame: 12 weeks ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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  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

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Shi YK, Wang L, Han BH, Li W, Yu P, Liu YP, Ding CM, Song X, Ma ZY, Ren XL, Feng JF, Zhang HL, Chen GY, Han XH, Wu N, Yao C, Song Y, Zhang SC, Song W, Liu XQ, Zhao SJ, Lin YC, Ye XQ, Li K, Shu YQ, Ding LM, Tan FL, Sun Y. First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma (CONVINCE): a phase 3, open-label, randomized study. Ann Oncol. 2017 Oct 1;28(10):2443-2450. doi: 10.1093/annonc/mdx359.

Responsible Party:	Betta Pharmaceuticals Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT01719536 History of Changes
Other Study ID Numbers:	BD-IC-IV36
First Posted:	November 1, 2012
Last Update Posted:	September 29, 2016
Last Verified:	September 2016

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