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

• ClinicalTrials.gov Identifier: NCT01719536
• Recruitment Status: Completed
• First Posted: November 1, 2012
• Last Update Posted: July 5, 2019
• Sponsor: Betta Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): Betta Pharmaceuticals Co., Ltd.

Tracking Information

• First Submitted Date: October 29, 2012
• First Posted Date: November 1, 2012
• Last Update Posted Date: July 5, 2019
• Study Start Date: December 2012
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 1, 2012)

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.

Original Primary Outcome Measures (submitted: October 29, 2012)

Progression Free Survival [ Time Frame: 9 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.

Current Secondary Outcome Measures (submitted: October 29, 2012)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients
• Official Title: Conmana Versus Pemetrexed-based First-line Induction and Maintenance Chemotherapy in Advanced Lung Adenocarcinoma With EGFR-mutation
• 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.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: NSCLC

Intervention

• Drug: Icotinib
  Icotinib: 125 mg is administered orally three times per day.
  Other Names:

  • BPI-2009
  • Conmana
• Drug: Chemotherapy
  First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
  Other Name: ALIMTA

Study Arms

• Experimental: Icotinib
  Icotinib 125mg is administered orally three times per day.
  Intervention: Drug: Icotinib
• 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.
  Intervention: Drug: Chemotherapy

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 28, 2016): 296
• Original Estimated Enrollment (submitted: October 29, 2012): 270
• Actual Study Completion Date: February 7, 2017
• Actual Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT01719536
• Other Study ID Numbers: BD-IC-IV36
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Betta Pharmaceuticals Co., Ltd.
• Study Sponsor: Betta Pharmaceuticals Co., Ltd.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Betta Pharmaceuticals Co., Ltd.
• Verification Date: July 2019