Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in Ⅲb/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation
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|ClinicalTrials.gov Identifier: NCT02066038|
Recruitment Status : Unknown
Verified February 2014 by LongHao, Sun Yat-sen University.
Recruitment status was: Active, not recruiting
First Posted : February 19, 2014
Last Update Posted : February 19, 2014
EGFR-tyrosine kinase inhibitor(TKI)- ie, erlotinib, gefitinib, 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 erlotinib, 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: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-center, Open-labeled Phase 2 Study of First Line Intermittent and Maintenance of Erlotinib in Combination With Pemetrexed/Carboplatin in ⅢB/IV Non Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Mutation|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||March 2016|
Pemetrexed 500mg/m2+Carboplatin area under curve(AUC)=5, every 3 weeks, maximum 4 cycles, Erlotinib 150mg/d every cycle d2-15, and Erlotinib 150mg/d from the last cycle until disease progression
150mg po on days 2-15 of each 3 week cycle for 4 cycles and 150mg po per day after 4 cycles until disease progression
Other Name: Tarceva
- Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 [ Time Frame: eight weeks ]Patients were imaged with computed tomography (CT) scan
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): NCT02066038
|Principal Investigator:||Hao Long, Prof||Sun Yat-sen University|