Icotinib Versus First-line Chemotherapy Plus Maintenance Treatment in EGFR Positive Lung Adenocarcinoma Patients (Convince)
|ClinicalTrials.gov Identifier: NCT01719536|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2012
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|NSCLC||Drug: Icotinib Drug: Chemotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||296 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Icotinib 125mg is administered orally three times per day.
Icotinib: 125 mg is administered orally three times per day.
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.
First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
Other Name: ALIMTA
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719536
Show 21 Study Locations
|Principal Investigator:||Shi Yuankai, M.D.||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|