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Report for Clinical Trial NCT02140333

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer

The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

NCT02140333 NSCLC EGFR Mutation

1 Interventions

Name: Erlotinib

Description: 100mg vs. 150mg

Type: Drug

Erlotinib 100mg Erlotinib 150mg

Primary Outcomes

Measure: Progression free survival

Time: 2 years after the initial dose

Secondary Outcomes

Measure: The objective response rate

Time: Patients will be followed for an expected average of 6 months

Other Outcomes

Measure: Overall survival

Time: 3 year after the initial dose

Measure: Adverse events

Time: 1 year

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

Inclusion Criteria: 1. Histological diagnosis of NSCLC with phase IIIB or IV disease; 2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method) 3. Never received anti-tumor therapies for the advanced stage; 4. Never used EGFR inhibitors; 5. Measurable disease by RECIST criteria; 6. --- L858R ---

HPO Nodes