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Report for Clinical Trial NCT02095782

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Intercalated Combination of Chemotherapy and Erlotinib in 1st Line Setting for Patients Advanced Stage Non-small-cell Lung Cancer With Low Abundant Activating EGFR Mutation(INNOVATE)

This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation.

NCT02095782 Non-small-cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Intercalated combination of chemotherapy and erlotinib

Description: Primary therapy stage: Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle. Maintenance therapy stage: Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.
Type: Drug
Group Labels: 1

chemotherapy and erlotinib


Primary Outcomes

Description: From start of anti-cancer therapy untill progression or death

Measure: Progression free survival defined by imagery methods

Time: 8 weeks

Secondary Outcomes

Description: From start of anti-cancer therapy till progression of death

Measure: Toxicities related to anti-cancer therapy

Time: 8 weeks

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods. --- L858R ---



HPO Nodes


HPO: