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Report for Clinical Trial NCT02066038

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT02066038 Lung, Carcinoma
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Erlotinib

Description: 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
Type: Drug
Group Labels: 1


Primary Outcomes

Description: Patients were imaged with computed tomography (CT) scan

Measure: Response Evaluation Criteria in Solid Tumors(RECIST) 1.1

Time: eight weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment

There is one SNP


1 L858R

- Confirmed activating mutation of EGFR—ie, an exon 19 deletion or an exon 21 L858R point mutation. --- L858R ---

HPO Nodes