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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
Group Labels: 1

S-1 plus Gefitinib

Name: Gefitinib

Description: Gefitinib: 250mg, 1 day, orally
Type: Drug
Group Labels: 1

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: