The Study Observes How Long Patients With Non-small Cell Lung Cancer (NSCLC) Benefit From Treatment With Epidermal Growth Factor Tyrosine Kinase Inhibitor (EGFR-TKI) When Given Either for Uncommon Mutations or for Common Mutations in the Sequence Afatinib Followed by Osimertinib

NCT04179890 | Completed Results

• 1 other identifier: 1200-0316
• Study Type: observational
• Target: 462
• Locations: 1 country
• Sites: 1

Brief Summary

Non-interventional, multi-country, multi-centre cohort study based on existing data from medical records (paper or electronic) or electronic health records of patients with advanced NSCLC harbouring EGFR mutations and treated with an EGFR-TKI

Conditions

Non-squamous, Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Time on Treatment With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

  Uncommon Mutation Cohort: Time on treatment with EGFR-TKI assessed as the time from start of EGFR-TKI treatment until the end of treatment or death by any cause is reported. Common mutation cohort: Time on treatment with EGFR-TKI assessed as the time from start of afatinib (Gi(l)otrif®) as first-line treatment until the end of the second line treatment (the last dose of osimertinib) or death date by any cause. Time on treatment was analysed using Kaplan-Meier method, and the median was tabulated along with two-sided 95% confidence interval using the Greenwood's variance estimate.

  Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.

Secondary Outcomes (15)

• Uncommon Epidermal Growth Factor Receptor (EGFR) Mutation Cohort: Overall Response Rate to Index Line Treatment

  Up to 13 years.

• Sequencing Cohort: Overall Response Rate to First Line Afatinib

  Up to 6 years.

• Sequencing Cohort: Overall Response Rate to Second-line Treatment Osimertinib

  Up to 6 years.

• Overall Survival

  Up to 13 years for Uncommon EGFR mutation cohort and up to 6 years for the Sequencing Cohort.

• Number of Participants for Each Type of Biological Samples Used for Mutation Detection at First Line Treatment Start

  At first-line treatment start (i.e. between 2007 and 2019 for the Uncommon Epidermal Growth Factor Receptor (EGFR) mutation cohort and between 2014 and 2018 for Sequencing Cohort).

Study Arms (2)

Uncommon EGFR mutation cohort

This arm included patients with Non-Small Cell Lung Cancer (NSCLC) carrying uncommon mutations in the epidermal growth factor receptor (EGFR) who were treated with the following Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs) as first or second-line therapy: * Afatinib (Gi(l)otrif®):50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®). * Erlotinib (Tarceva®): 25mg or 100mg or 150mg tablet once daily as indicated in the approved labels of erlotinib (Tarceva®). * Gefitinib (IRESSA®): 250mg tablet once daily as indicated in the approved labels of gefitinib (IRESSA®). * Osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib). In the first- or second-line with a threshold of start of treatment of at least 12 months respectively prior to data entry.

Drug: Afatinib (Gi(l)otrif®); Drug: Erlotinib (Tarceva®); Drug: Gefitinib (IRESSA®); Drug: Osimertinib (Tagrisso®)

Sequencing cohort

This arm included Non-Small Cell Lung Cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutation positive who received the following treatment sequence: \- Afatinib (Gi(l)otrif®): 50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi(l)otrif®) as first line therapy, in the case the T790M resistance mutation was developed (second line therapy) the patients received osimertinib (Tagrisso®): 80 mg or 40 mg tablets once daily as indicated in the approved labels of osimertinib; the threshold of start of osimertinib at least 10 months prior to data entry.

Drug: Afatinib (Gi(l)otrif®); Drug: Osimertinib (Tagrisso®)

Interventions

Afatinib (Gi(l)otrif®) DRUG

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

Uncommon EGFR mutation cohort

Erlotinib (Tarceva®) DRUG

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

Uncommon EGFR mutation cohort

Gefitinib (IRESSA®) DRUG

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

Uncommon EGFR mutation cohort

Osimertinib (Tagrisso®) DRUG

Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) as first or second-line therapy.

Uncommon EGFR mutation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naïve advanced EGFR mutated non-small cell lung cancer (NSCLC),

You may qualify if:

• Adult patients
• Diagnosed with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFRTKI) naive advanced EGFR mutated non-small cell lung cancer (NSCLC),
• treated for Epidermal Growth Factor Receptor (EGFR) mutated NSCLC within regular clinical practice.
• Informed and privacy consent signature must be obtained depending on local regulations.
• Uncommon mutation cohort:
• Patients harbouring uncommon or compound EGFR mutations
• Patients who started with either afatinib (Gi(l)otrif®), gefitinib (Iressa®), erlotinib (Tarceva®), or osimertinib (Tagrisso®) in the first- or second-line setting within regular clinical practice
• Patients must have started EGFR-TKI treatment at least 12 months prior to data entry.
• Sequencing cohort:
• \. Patients with common EGFR mutations (Del19, L858R) 6. Patients were treated with afatinib (Gi(l)otrif®) in the first-line setting and for acquired T790M mutation with osimertinib in the second line; 7. Patients must have started osimertinib treatment at least 10 months prior to data entry.
• Patients treated with osimertinib within an early access program/ compassionate use program (EAP/CUP) are allowed

You may not qualify if:

• Patients treated for EGFR mutated NSCLC within a clinical trial or participated in GioTag study.
• Patients with active brain metastases at start of EGFR-TKI therapy (independent of treatment line)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

Location

Related Publications (1)

• Popat S, Hsia TC, Hung JY, Jung HA, Shih JY, Park CK, Lee SH, Okamoto T, Ahn HK, Lee YC, Sato Y, Lee SS, Mascaux C, Daoud H, Marten A, Miura S. Tyrosine Kinase Inhibitor Activity in Patients with NSCLC Harboring Uncommon EGFR Mutations: A Retrospective International Cohort Study (UpSwinG). Oncologist. 2022 Apr 5;27(4):255-265. doi: 10.1093/oncolo/oyac022.

  PMID: 35274704 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; Erlotinib Hydrochloride; Gefitinib; osimertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

As in all studies based on secondary use of data, the risk of missing data shall be taken into consideration. Stratified analyses include no formal testing for statistical significance since such analyses have a descriptive exploratory purpose. In fact, no a priori hypotheses were defined. Patient's duration of observation was different for each subject without specific censoring rules by protocol, and there were no limitations on time periods for starting treatments by protocol.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 27, 2019
• Study Start: December 17, 2019
• Primary Completion: July 22, 2021
• Study Completion: July 22, 2021
• Last Updated: May 25, 2023
• Results First Posted: May 25, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)