Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients (Convince)
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| ClinicalTrials.gov Identifier: NCT01719536 |
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Recruitment Status :
Completed
First Posted : November 1, 2012
Last Update Posted : July 5, 2019
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Sponsor:
Betta Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.
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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 |
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 (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 |
| Actual Primary Completion Date : | September 2016 |
| Actual Study Completion Date : | February 7, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Icotinib
Icotinib 125mg is administered orally three times per day.
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Drug: Icotinib
Icotinib: 125 mg is administered orally three times per day.
Other Names:
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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.
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Drug: Chemotherapy
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Other Name: ALIMTA |
Primary Outcome Measures :
- 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 :
- 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.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719536
Locations
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 |
Publications of Results:
| Responsible Party: | Betta Pharmaceuticals Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT01719536 |
| Other Study ID Numbers: |
BD-IC-IV36 |
| First Posted: | November 1, 2012 Key Record Dates |
| Last Update Posted: | July 5, 2019 |
| Last Verified: | July 2019 |
Additional relevant MeSH terms:
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Adenocarcinoma Adenocarcinoma of Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |