Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

• ClinicalTrials.gov Identifier: NCT04795245
• Recruitment Status: Active, not recruiting
• First Posted: March 12, 2021
• Last Update Posted: March 8, 2022
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC).

The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.

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

Study Design

• Study Type: Observational
• Actual Enrollment: 800 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma
• Actual Study Start Date: August 26, 2021
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: March 31, 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
patients treated with afatinib	Drug: afatinib; afatinib; Other Name: Giotrif®

Outcome Measures

Primary Outcome Measures :

1. Time on Treatment (TOT) with afatinib in first-line TOT (TOT1) [ Time Frame: up to 48 months ]
   This will be assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause.

Secondary Outcome Measures :

1. TOT from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause [ Time Frame: up to 48 months ]
2. TOT from start of the second-line treatment until end of the second-line treatment or death by any case (TOT2) [ Time Frame: up to 48 months ]
3. overall survival [ Time Frame: at month 18 and at month 36 ]
4. survival rate [ Time Frame: at month 18 and at month 36 ]
5. time to initial dose reduction of afatinib [ Time Frame: up to 48 months ]
6. proportion of patients with dose modifications of afatinib [ Time Frame: up to 48 months ]

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

The patients who were treated with afatinib in the first-line setting in each study site after the launch of Giotrif® on 7 May 2014 on a regular basis; their information will be chosen.

Deceased patients fulfilling the eligibility criteria should be enrolled whenever possible.

Criteria

Inclusion Criteria:

• Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC)
• Patients who were/are treated with afatinib in the first-line setting at least 20 months* prior to data entry
• Patients 20 years of age or older at the time of consent
• Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) * Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.

Exclusion Criteria:

• Any contraindication to afatinib as specified in the label of Giotrif®
• Patients treated with afatinib within an interventional trial
• Patients with active brain metastases at start of afatinib treatment* * Patients with non-active brain metastases (asymptomatic state) are eligible.

Contacts and Locations

Locations

Japan

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan, 141-6017

Sponsors and Collaborators

Boehringer Ingelheim

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT04795245
• Other Study ID Numbers: 1200-0322
• First Posted: March 12, 2021
• Last Update Posted: March 8, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Adenocarcinoma; Adenocarcinoma of Lung; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Afatinib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action