Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy

NCT04930133 | Unknown

• 1 other identifier: TOAST
• Study Type: observational
• Target: 737
• Locations: 1 country
• Sites: 1

Brief Summary

The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while \> 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.

Conditions

NSCLC

Keywords

T790; afatinib

Outcome Measures

Primary Outcomes (1)

• Total TOT

  the time on treatment (total TOT) of EGFR M+ NSCLC patients treated with afatinib in the first-line (TOT-1) followed by second line treatments(TOT-2) including osimertinib, chemotherapy and other treatments.

  Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

Secondary Outcomes (2)

• objective response rate (ORR-1 & ORR-2's)

  Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

• overall survival time

  Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

Study Arms (4)

Cohort A

T790M+ patients sequentially treated with osimertinib in cohort A

Drug: Gilotrif

Cohort B

T790M- patients treated with chemotherapy or other treatments in cohort B

Drug: Gilotrif

Cohort C

patients with unknown mutation status in cohort C

Drug: Gilotrif

Cohort D

Cohort D included patients who were still ongoing with afatinib.

Drug: Gilotrif

Interventions

Gilotrif DRUG

This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.

Cohort A; Cohort B; Cohort C; Cohort D

Eligibility Criteria

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

Study Population

non-interventional, multi-center, multi-cohort

You may qualify if:

• Age more than 18 years
• Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)
• Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.

You may not qualify if:

• Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment
• Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A'

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Jin Hyoung Kang

Seoul, 06591, South Korea

Location

MeSH Terms

Interventions

Afatinib

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jin Hyoung Kang

  Seoul St. Mary's Hospital, The Catholic University of Korea

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division of Medical Oncology, Department of Internal Medicine

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 18, 2021
• Study Start: February 24, 2020
• Primary Completion: December 17, 2020
• Study Completion: September 30, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

KR (1)