The START Study Observes Afatinib as First-line Treatment and Sequential Therapy in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Nonsmall Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-squamous, Non-Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Afatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC Male and female patients with age ≥18 years Written informed consent per local regulatory requirement Exclusion Criteria: Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted) Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with non-small cell lung cancer (NSCLC)<br> | Drug: Afatinib<br>* drug<br>* Other names: Giotrif®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 months | 
| Overall Survival from the start of afatinib until the date of death |  | 50 months | 
| Progression-Free Survival as judged by an investigator with afatinib in first-line treatment |  | 33 months | 
| Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1 |  | 33 months | 
| Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1 |  | 33 months | 
| Proportion of resistance mechanisms after afatinib first-line |  | 12 months | 
| 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) |  | 50 months |