SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03381430

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Open-label, One-arm Trial of Gefitinib Combined With Radiotherapy as Adjuvant Therapy in Completely Resected Patients With Pathological Stage IIIA-N2 Non-small Cell Lung Cancer Harbouring Sensitive Mutations of EGFR

To explore the survival benefit of the gefitinib combined with radiotherapy as adjuvant therapy for completely resected patients with Pathological stage IIIA-N2 NSCLC harbouring sensitive mutations of EGFR.

NCT03381430 Lung Cancer
MeSH: Lung Neoplasms
HPO: Neoplasm of the lung

1 Interventions

Name: Gefitinib

Description: Gefitinib 250 mg/day oral daily

Type: Drug

Gefitinib + Radiotherapy


Primary Outcomes

Description: From start of anti-cancer therapy until progression or death. To evaluate the disease free survival of gefitinib combined with radiotherapy as adjuvant therapy in completely resected patients with Pathological stage IIIA-pN2 NSCLC harbouring sensitive mutations of EGFR.Disease free survival (DFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.

Measure: Disease free survival

Time: CT scan, abdominal ultrasound every 3 months, brain MRI every 6 months, bone scan every 12 months for up to 3 years.

Secondary Outcomes

Description: evaluated in the 6 years since treatment begain

Measure: Overall survival

Time: 6 years

Description: To compare the adjuvant treatment arm in terms of 3 yeas DFS rate.

Measure: 3 yeas DFS rate

Time: 3 years

Description: To compare the adjuvant treatment arm in terms of 5 years DFS rate.

Measure: 5 years DFS rate

Time: 5 years

Description: To compare the adjuvant treatment arm in terms of 5 years OS rate.

Measure: 5 years OS rate

Time: 5 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: In the period of Gefitinib 250 mg/day oral daily for 24 months. Radiotherapy total dose 50-54Gy, divided dose 1.8-2Gy.

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

- Target population is completely resected pathological stage IIIA-N2 NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation. --- L858R ---


2 T790M

- Patients who harbouring exon 20 T790M mutation. --- T790M ---



HPO Nodes


HPO:
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