SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03457337

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Randomized, Controlled, Open-label, Prospective Trial of S-1 Plus Gefitinib Versus Gefitinib Monotherapy for First-line Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With EGFR-sensitive Mutation

To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus gefitinib versus gefitinib monotherapy

NCT03457337 EGFR-sensitive Mutation-positive Advanced Non-squamous Non-small Cell Lung Cancer Treated With S-1plus Gefitinib Versus Gefitinib Monotherapy
MeSH: Lung Neoplasms Carcinoma, Non-Small-Cell Lung Hypersensitivity
HPO: Allergy Neoplasm of the lung Non-small cell lung carcinoma

2 Interventions

Name: S-1 plus Gefitinib

Description: S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally Gefitinib: 250mg, 1 day, orally, fasting or with the same service

Type: Drug

S-1 plus Gefitinib

Name: Gefitinib

Description: Gefitinib: 250mg, 1 day, orally

Type: Drug

Gefitinib


Primary Outcomes

Description: From start of anti-cancer therapy until progression or death.To evaluate the disease free survival of gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR. Progression free survival (PFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.

Measure: Progression free survival(PFS)

Time: 2 years

Secondary Outcomes

Description: To evaluate the overall survivalof gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR in the 3 years since treatment begain

Measure: Overall survival(OS)

Time: 3 years

Description: To compare disease control rate of the two arms from start of anti-cancer therapy until progression

Measure: Disease control rate

Time: 2 years

Description: To compare objective response rate of the two arms from start of anti-cancer therapy until progression

Measure: Objective response rate(ORR)

Time: 2 years

Description: The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.

Measure: Number of Participants with Adverse Events

Time: 3 years

Other Outcomes

Description: Quality of Life Questionnaire(such as QLQ-C30 and QLQ-LC13) evaluated since treatment began.At the end of the trial, the differences between the two indicators were compared with Mixed-effects model repeated measures (MMRM), where the baseline was scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline were statistically described.

Measure: Assessment of Health-related quality of life

Time: 3 years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

4. exon 19 deletion or exon 21 L858R for EGFR mutation. --- L858R ---



HPO Nodes


HPO:
Allergy
Genes 21
CHD1 TGM5 ADA PLA2G7 MTOR FOXP3 PGM3 CARMIL2 SIK3 CCDC28B BBS1 NRXN1 IL4R COX4I2 MS4A2 PLCG2 SPINK5 CSTA CNTNAP2 RBM8A PGM3
Neoplasm of the lung
Genes 61
REST GPC3 WT1 HPGD BRAF PIK3CA TP53 TRIM28 RB1 TRIP13 SLCO2A1 AKT1 CASP8 KRAS TSC1 POU6F2 EWSR1 PRKN LMNA NAB2 TERT TSC2 SLC22A18 BRCA2 PPP2R1B STAT6 STK11 MUC5B ERBB2 TSC2 MBTPS2 BAP1 TSC2 DICER1 PDGFRB PERP EGFR TSC1 DIS3L2 NOTCH3 KEAP1 DICER1 DICER1 WT1 TSC1 C11ORF95 IRF1 CYP2A6 WRN RELA WT1 PTEN SFTPC SFTPA2 ERCC6 TRPV3 TP53 H19 TRIM28 FASLG MAP3K8
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1