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Report for Clinical Trial NCT04206787

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

START: Real-world Study on Sequential Therapy With Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NSCLC)

This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.

NCT04206787 Non-squamous, Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cel Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Afatinib

Description: drug
Type: Drug
Group Labels: 1

Patients with non-small cell lung cancer (NSCLC)


Primary Outcomes

Measure: Time on treatment (TOT) of afatinib as firstline treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC

Time: 28 months

Secondary Outcomes

Measure: Time on treatment (TOT) with afatinib as first-line treatment followed by investigator's choice treatment in event of the T790M negative status in real-world setting

Time: 28 months

Measure: Overall Survival from the start of afatinib until the date of death

Time: 50 months

Measure: Progression-Free Survival as judged by an investigator with afatinib in first-line treatment

Time: 33 months

Measure: Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1

Time: 33 months

Measure: Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1

Time: 33 months

Measure: Proportion of resistance mechanisms after afatinib first-line

Time: 12 months

Measure: Adverse Event(s), Serious Adverse Event (s), afatinib-related AEs (ADRs) as indicated by incidence seriousness and intensity grade according to United States (US) national cancer institute's (NCI) (CTCAE Version 5.0)

Time: 50 months

Time Perspective: Prospective

Other


There is one SNP

SNPs


1 T790M

Time on treatment (TOT) of afatinib as firstline treatment followed by 3rd generation EGFR-TKI in the event of the T790M resistance mutation is developed in patients with EGFR mutation-positive NSCLC. --- T790M ---

Time on treatment (TOT) with afatinib as first-line treatment followed by investigator's choice treatment in event of the T790M negative status in real-world setting. --- T790M ---



HPO Nodes


HPO: