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Report for Clinical Trial NCT01955421

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Open-label Phase II Trial of Erlotinib 100mg Daily Versus Gefitinib 250mg Daily in Patients With Advanced Non-small Cell Lung Cancer Who Harbor EGFR Mutations.

This study is a multicenter, randomized, open-label Phase II trial that compares reduced dose erlotinib 100mg daily and standard dose gefitinib 250mg daily in patients with advanced non-small cell lung cancer who harbor EGFR mutations. The primary endpoint is disease control rate (DCR) and the key secondary endpoint is progression free survival (PFS). A total of 224 eligible patients will be randomized to receive either erlotinib 100mg daily or gefitinib 250mg daily in a 1:1 ratio until patients experience disease progression. Independent assessment of the major endpoints will be completed in a treatment-blinded manner. Randomization will be stratified based on treatment-lines (first-line vs. maintenance vs. second-line therapy). Tumor response and progression will be assessed according to RECIST 1.1.

NCT01955421 Advanced Stage Non Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: Erlotinib 100mg qd

Type: Drug
Group Labels: 1


Name: Gefitinib 250mg qd

Type: Drug
Group Labels: 1


Primary Outcomes

Measure: disease control rate

Time: 2 years

Secondary Outcomes

Measure: progression free survival

Time: 2 years

Description: rash, diarrhea, ILD, etc.

Measure: adverse events

Time: 2 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

2. Harboring a PCR-confirmed activating mutation of EGFR, including an exon 19 deletion or an exon 21 L858R point mutation. --- L858R ---

HPO Nodes