Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
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|ClinicalTrials.gov Identifier: NCT03151161|
Recruitment Status : Unknown
Verified June 2018 by Hao Long, Sun Yat-sen University.
Recruitment status was: Not yet recruiting
First Posted : May 12, 2017
Last Update Posted : June 7, 2018
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, icotinib,has been recommended as the first option for EGFR-mutated IIIb/IV NSCLC by serial trials as it prolonged patients' progression-free survival. The OPTIMAl trial indicated that those who received TKI and chemotherapy during the whole treatment window survived longest. Unfortunately, previous studies(INTACT, TRIBUTE et al) that concurrently combined TKI and cytotoxic regimens failed to improve survival in unselected patients. To avoid the potential synergistic antagonism, the FAST-ACT II trial committed a sequential strategy and find a superiority in the combination arm upon chemotherapy even in EGFR-mutated group. However, pharmaceutically, the continuous administration of an EGFR-TKI before subsequent chemotherapy in FAST-ACT II could obviate the effects of cytotoxic agents due to the erlotinib-induced G1 arrest.
On the basis of these and other studies, the investigators hypothesized that a better sequential combination strategy of EGFR-TKI and chemotherapy (adding a EGFR-TKI wash-out window before chemotherapy) would be more efficacious than chemotherapy alone. In this study, the investigators investigate the efficacy(PFS:progression free survival), safety, and adverse-event profile of chemotherapy plus intermittent and maintenance of icotinib compared with icotinib single drug, when these drugs were used as first-line treatment in who had non-squamous lung carcinoma with EGFR gene mutation in China.
|Condition or disease||Intervention/treatment||Phase|
|Lung, Carcinoma||Drug: Icotinib,Pemetrexed,Carboplatin Drug: Icotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective,Multi-center, Open-labeled Phase 2 Randomized and Comparative Clinical Study of First Line Intermittent and Maintenance of Icotinib in Combination With Pemetrexed/Carboplatin Compared With Icotinib Single Drug in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||May 2019|
Experimental: Experimental Group
Pemetrexed (500mg/m2) + Carboplatin (AUC=5), every 3 weeks, maximum 4 cycles; icotinib 125mg, three times a day, d2-15 in each cycle, and icotinib 125mg,three times a day, since the last cycle until disease progression
Active Comparator: Control Group
Single drug: Icotinib 125mg, three times a day, continous until disease progression
Single drug: Icotinib 125mg, three times a day, continuous until disease progression.
- Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 [ Time Frame: eight weeks ]Patients were images with computed tomography (CT) scan
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151161
|Contact: Hao Long, Prof||+86 20 email@example.com|
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