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
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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.
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)
Actual Study Start Date :
May 20, 2020
Estimated Primary Completion Date :
December 15, 2023
Estimated Study Completion Date :
October 15, 2025
Resource links provided by the National Library of Medicine
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 Frame: 28 months ]
Secondary Outcome Measures :
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 Frame: 28 months ]
Overall Survival from the start of afatinib until the date of death [ Time Frame: 50 months ]
Progression-Free Survival as judged by an investigator with afatinib in first-line treatment [ Time Frame: 33 months ]
Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1 [ Time Frame: 33 months ]
Disease Control Rate [DC is defined as best overall response of CR, PR, and SD] according to to RECIST 1.1 [ Time Frame: 33 months ]
Proportion of resistance mechanisms after afatinib first-line [ Time Frame: 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) [ Time Frame: 50 months ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Eligible patients will be enrolled in this study and will receive afatinib (first-line) and subsequent treatment (second-line) of either 3rd generation EGFR TKI or other treatments
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
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
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://trials.boehringer-ingelheim.com/trial_results/clinical_submission_documents.html to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".Also, Researchers can use the following link http://trials.boehringer-ingelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.The data shared are the raw clinical study data sets.
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'.For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
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Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action