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

Conditions

• Lung, Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Erlotinib — DRUG
  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

Study Details

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.

Key Dates

First listed

Feb 19, 2014

Start date

Jan 31, 2014

Status verified

Feb 2014

Primary completion

Apr 30, 2015

Completion

Mar 31, 2016

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: A
  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

Primary Outcome Measure

Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 [ Time Frame: eight weeks ]