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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206787
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Non-squamous, Non-Small Cell Lung Cancer Drug: Afatinib

Study Design
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Study Type : Observational
Estimated Enrollment : 825 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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


Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with non-small cell lung cancer (NSCLC) Drug: Afatinib
drug
Other Name: Giotrif®


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Overall Survival from the start of afatinib until the date of death [ Time Frame: 50 months ]
  3. Progression-Free Survival as judged by an investigator with afatinib in first-line treatment [ Time Frame: 33 months ]
  4. Objective Response Rate [OR is defined as best overall response of CR and PR] according to RECIST 1.1 [ Time Frame: 33 months ]
  5. 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 ]
  6. Proportion of resistance mechanisms after afatinib first-line [ Time Frame: 12 months ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206787


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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China
West China Hospital Recruiting
Chengdu, China, 610041
Contact: Yongsheng Wang    18980602258    wangy756@163.com   
Hainan Cancer Hospital Recruiting
Haikou, China, 570312
Contact: Jun Wu    13627537300    wujun19692000@163.com   
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, China, 310003
Contact: Jianying Zhou    13505719970    drzjy@163.com   
Shenzhen People's Hospital Recruiting
Shenzhen, China, 518020
Contact: Lin Yang    13798314779    13798314779@163.com   
Sponsors and Collaborators
Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04206787    
Other Study ID Numbers: 1200-0318
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: 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.
Access Criteria: 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'.
URL: https://trials.boehringer-ingelheim.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Afatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action