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Report for Clinical Trial NCT01683175

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation

This study is to compare 2-year Disease Free Survival Rate (DFSR) in post radical operation IIIA Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) 19 or 21 exon mutation treated Erlotinib vs NP chemotherapy as adjuvant therapy.

NCT01683175 Non-small Cell Lung Cancer Stage III
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

3 Interventions

Name: Erlotinib

Type: Drug

Arm 1

Name: cis-platinum

Type: Drug

Arm 2

Name: Vinorelbine

Type: Drug

Arm 2


Primary Outcomes

Description: 2-year disease free survival rate is defined as the estimation percentage of disease free survival patients with study treatment at 2-year.

Measure: 2-year disease free survival rate (DFSR)

Time: 2 years

Secondary Outcomes

Description: Disease free survival is defined as the time from randomization to disease recurrence or death which comes first.

Measure: disease free survival

Time: 5 years

Description: Overall survival is defined as the time from randomization to death.

Measure: overall survival (OS)

Time: 5 years

Description: The score of Functional Assessment of Cancer Therapy - Lung (FACT-L) subscale and Lung Cancer Symptom Scale (LCSS)

Measure: Quality of Life

Time: 5 years

Description: frequency of Adverse Event

Measure: Adverse Event (AE)

Time: 5 years

Description: Frequency of Serious Adverse Event (SAE)

Measure: Serious Adverse Event (SAE)

Time: 5 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - IIIA NSCLC patients according to TMN-staging of Lung Staging Standard version 7 2009, confirmed by histopathology or cytology after radical operation, and having EGFR exon 19 deletion mutation or exon 21 L858R single base substitution; - Accept study adjuvant therapy within 6 weeks post radical operation; - ECOP PS 0-1; Life expectancy ≥12 weeks; - Hematology: absolute neutrophil count (ANC) ≥1.5×10^9/L; platelet count ≥100×10^9/L; hemoglobin concentration ≥ 9.0 g/dL (permit to maintain hematologic criteria by blood transfusion); - Liver Function: TBil ≤1.5xULN; ALT and AST ≤2.5xULN; - Renal Function: Cr ≤1.25xULN, and Ccr ≥60ml/min; - Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before study treatment; - Signed inform consent form by patient or his/her legal representative; - Comply with study protocol and procedure, and be able to take oral medication; Aged ≥18 years and ≦75 years; - Eligible patients of reproductive potential (both sexes) must agree to use a reliable method of birth control before enrollment, during the study period and for at least 30 days after their last dose of study therapy; Exclusion Criteria: - Having treated by Her-Target therapy, i.e. erlotinib, gefitinib, cetuximab, trastuzumab; - Having treated by any systemic anti-tumor therapy of NSCLC, including cytotoxic therapy, target medication treatment (i.e. --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1