Afatinib Osimertinib Sequencing NIS

NCT03370770 | Completed Results FDA Drug

• 1 other identifier: 1200-0286
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib

  Time on treatment, which was defined as time in months from the start date of Afatinib (Gi\[l\]otrif®) treatment ('start date of initial dose' for First-Line Treatment) to the end date of Osimertinib treatment (maximum between 'end date of initial dose' and the last 'end date of dose modification' for Second-Line Treatment) or death date due to any cause ('date of death'). Time on treatment (months) = Time on treatment (days)/30.4375. 'Time on treatment was analysed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval was displayed using the Greenwood's formula for estimation of standard errors.

  Data collected from start of treatment until data entry completion, up to 96.8 months for first analysis and up to 114.1 months for the extension analysis.

Secondary Outcomes (1)

• The Percentage of Participants With Different Types of Mutations After Categorisation

  Data collected from start of treatment until data entry completion; up to 96.8 months.

Study Arms (1)

patients with EGFR mutation-positive NSCLC

(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)

Drug: Afatinib; Drug: Osimertinib

Interventions

Afatinib DRUG

GILOTRIF, GIOTRIF, XOVOLTIB

patients with EGFR mutation-positive NSCLC

Osimertinib DRUG

on T790M resistance mutation was developed

patients with EGFR mutation-positive NSCLC

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

Study is planned that around 65 study centres in 11 countries will be participating in this noninterventional study and at least 190 consecutive eligible patients will be enrolled to the study. Every patient who fulfils inclusion and exclusion criteria and agree to participate in the study (if a written informed consent is required for this NIS by local regulation and legal requirement) will be selected until the required sample size is achieved.

You may qualify if:

• Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
• The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
• Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
• Patients treated with osimertinib within an EAP/CUP or regular clinical practice
• Age ≥ 18 years
• Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)

You may not qualify if:

• Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
• Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Otto-Wagner Hospital

Vienna, 1140, Austria

Location

Related Publications (5)

• Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020 Dec;16(34):2799-2808. doi: 10.2217/fon-2020-0740. Epub 2020 Aug 28.

  PMID: 32854536 DERIVED

• Feinberg B, Halmos B, Gucalp R, Tang W, Moehring B, Hochmair MJ. Making the case for EGFR TKI sequencing in EGFR mutation-positive NSCLC: a GioTag study US patient analysis. Future Oncol. 2020 Aug;16(22):1585-1595. doi: 10.2217/fon-2020-0188. Epub 2020 Aug 6.

  PMID: 32757853 DERIVED

• Yamamoto N, Mera T, Marten A, Hochmair MJ. Observational Study of Sequential Afatinib and Osimertinib in EGFR Mutation-Positive NSCLC: Patients Treated with a 40-mg Starting Dose of Afatinib. Adv Ther. 2020 Feb;37(2):759-769. doi: 10.1007/s12325-019-01187-y. Epub 2019 Dec 20.

  PMID: 31863283 DERIVED

• Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study. Future Oncol. 2019 Sep;15(25):2905-2914. doi: 10.2217/fon-2019-0346. Epub 2019 Aug 2.

  PMID: 31370698 DERIVED

• Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Golembesky A, Marten A, Cufer T. Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study. Future Oncol. 2018 Nov;14(27):2861-2874. doi: 10.2217/fon-2018-0711. Epub 2018 Oct 19.

  PMID: 30336693 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Afatinib; 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

This study has no comparator group limiting the interpretability of the results as they cannot be put into perspective.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Centre
• 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: December 7, 2017
• First Posted: December 12, 2017
• Study Start: December 28, 2017
• Primary Completion: November 28, 2019
• Study Completion: November 28, 2019
• Last Updated: December 24, 2020
• Results First Posted: December 24, 2020

Record last verified: 2020-12

Locations

AU (1)