SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01665417

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Randomized, Open Label, Positive Controlled, Multicenter Trial to Evaluate Icotinib as First-line and Maintenance Treatment in EGFR Mutated Patients With Lung Adenocarcinoma

This study is designed to compare the efficacy and safety of first-line icotinib treatment and first-line chemotherapy followed by maintenance treatment with icotinib.

NCT01665417 EGFR Positive Non-small Cell Lung Cancer Adenocarcinoma
MeSH: Carcinoma, Non-Small-Cell Lung Adenocarcinoma Adenocarcinoma of Lung
HPO: Non-small cell lung carcinoma

3 Interventions

Name: Experimental

Description: Icotinib: 125mg, oral administration, three times per day.

Type: Drug

Experimental Icotinib

Name: Chemotherapy

Description: Chemotherapy Regimen 1:Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Type: Drug

Chemotherapy Regimen 1 Chemotherapy Regimen 2

Name: Chemotherapy

Description: Chemotherapy Regimen 2:Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.

Type: Drug

Chemotherapy Regimen 1 Chemotherapy Regimen 2


Primary Outcomes

Description: PFS was defined as the time from the date of first dose of study medication to the date of first documentation of tumor progression or death due to any cause, whichever occurred first.

Measure: Progression-free survival

Time: 8 months

Secondary Outcomes

Description: OS was assessed via calculation of the time to death due to any cause from the date of randomization. A patient was censored at the last date they were known to be alive.

Measure: Overall survival

Time: 24 months

Description: TTP was defined as the time from the date of first dose of study medication to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first dose date +1)/7. Kaplan-Meier method was used.

Measure: Time to Tumor Progression

Time: 8 months

Description: Number of Subjects With Overall Confirmed Objective Disease Response According to the Response Evaluation Criteria in Solid Tumors(RECIST)1.1.

Measure: Objective response rate

Time: 3 months

Description: Adverse events assessed by CTCAE4.0.

Measure: Number of participants with adverse events

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

Adverse events assessed by CTCAE4.0.. Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R). --- L858R ---

Exclusion Criteria: - Prior chemotherapy Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR Patients must not be receiving any other investigational agents Any evidence of interstitial lung disease Inclusion Criteria: - Pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on CT); Patients must have previously untreated locally advanced or metastatic NSCLC; Patients must have lung cancer with a documented EGFR activating mutation (exon 19 deletion, L858R). --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1