A Chart Review Study of Adults With Advanced NSCLC (EXTRACT)

Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations

The main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic NSCLC with epidermal growth factor receptor (EGFR) exon-20 driven mutations. Past medical records will be reviewed. No clinic visits or procedures will be required.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer (NSCLC)

Detailed Description

This is a retrospective, observational study in participants with advanced NSCLC with EGFR exon-20 driven mutations. This study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (HCRU) in a routine clinical practice setting in the real world.

The study will enroll approximately 218 participants. Participants who were treated at the participating sites between 01 January 2017 and 30 November 2021 will be included. The data will be collected retrospectively at the specialized centers from the participants medical records and notes. All the participants will be assigned to a single observational cohort:

• Participants With Advanced NSCLC With EGFR Exon-20 Mutations

This multi-center study will be conducted in Canada, France and Hong Kong. The overall duration of the study will be 6 months.

• Study Type: Observational
• Enrollment (Actual): 179

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System
    • Kitchener, Ontario, Canada, N2G 1G3
      • Grand River Hospital
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital Research Institute.
    • Toronto, Ontario, Canada, M5G 1L7
      • University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower
• France
  • Paris, France, 75020
    • Hopital Tenon
  • Aisne
    • Saint-Quentin cedex, Aisne, France, 2321
      • Centre Hospitalier de Saint-Quentin
  • Bouches-du-Rhone
    • Marseille, Bouches-du-Rhone, France, 13015
      • Hôpital Nord - CHU Marseille
  • Calvados
    • Caen Cedex 05, Calvados, France, 14076
      • Centre Francois Baclesse
  • Cote-d'Or
    • Dijon Cedex, Cote-d'Or, France, 21034
      • Centre Georges François Leclerc
  • Finistere
    • Brest Cedex, Finistere, France, 29200
      • Chu Brest - Hôpital Morvan
  • Gironde
    • Bordeaux cedex, Gironde, France, 33076
      • Institut Bergonie
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31000
      • Hopital Larrey
  • Haute Savoie
    • Pringy cedex, Haute Savoie, France, 74374
      • Centre Hospitalier de la Région d'Annecy
  • Nord
    • Lille Cedex, Nord, France, 59037
      • Hopital Albert Calmette - CHU Lille
  • Paris
    • Paris Cedex 05, Paris, France, 75005
      • Institut Curie - Site de Paris
  • Puy De Dome
    • Clermont Ferrand cedex, Puy De Dome, France, 63003
      • CHU Clermont-Ferrand
  • Rhone
    • Lyon, Rhone, France, 69008
      • Centre Léon Bérard
    • Lyon, Rhone, France, 69677
      • Hospices Civils de Lyon
    • Strasbourg, Rhone, France, 67091
      • CHU Strasbourg - Nouvel Hopital Civil
  • Seine Saint Denis
    • Saint-Pierre, Seine Saint Denis, France, 97400
      • Centre Hospitalier Regional de la Reunion
  • Vaculuse
    • Avignon, Vaculuse, France, 84000
      • Hospital Center Henri Duffaut
  • Val De Marne
    • Creteil Cedex, Val De Marne, France, 94010
      • Centre Hospitalier Intercommunal de Creteil
  • Vienne
    • Poitiers, Vienne, France, 86021
      • CHU Poitiers - Hôpital la Milétrie
  • Yvelines
    • Versailles, Yvelines, France, 78000
      • Hopital de Versailles
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
  • Hong Kong, Hong Kong
    • Tuen Mun Hospital
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong
    • Queen Elizabeth Hospital
  • Hong Kong, Hong Kong
    • Pamela Youde Nethersole Eastern Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who were diagnosed with advanced NSCLC with EGFR ex20ins mutations and who were treated at the participating sites will be included until end of follow-up or death, whichever occurs first.

Description

Inclusion Criteria

1. Histologically/cytologically confirmed diagnosis of locally advanced or metastatic (Stage IIb to IV) NSCLC with EGFR ex20ins mutations (based on the evaluation by the treating center) between 01 January 2017 and 30 November 2021.
2. Followed-up at the site between 01 January 2017 and 30 November 2021 for his/her advanced NSCLC, irrespective of their current survival status.

Exclusion Criteria

1. Participants whose investigator has access to fewer than two registered visits for his/her advanced NSCLC between 01 January 2017 and 30 November 2021.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants With Advanced NSCLC With EGFR Exon-20 Mutations; Participants diagnosed with advanced NSCLC with EGFR exon 20 insertions (ex20ins) mutations who were treated according to routine clinical practice will be observed retrospectively up to 6 months or until the end of follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world Progression Free Survival (rwPFS)	rwPFS is defined as the time elapsed from the initiation of a new treatment line to real-world progressive disease (rwPD) or death, whichever occurred first. rwPD: unequivocal increase in visible disease/disease burden or presence of new lesions. Participants will be censored at the end of the line of therapy or date of last contact available.	Up to 6 months
Real-world Overall Response Rate (rwORR)	Overall response rate (ORR) is the percentage of participants on a treatment line who achieve real-world complete response (rwCR) or real-world partial response (rwPR) as best response per treatment line. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some, or all, areas without any increase in visible disease.	Up to 6 months
Confirmed Real-world Overall Response Rate (rwCORR)	ORR is the percentage of participants on a treatment line who achieve confirmed rwCR or rwPR as best response per treatment line. Confirmed responses are responses that persist greater than or equal to (>=) 4 weeks after initial response. rwCR: complete resolution of disease; rwPR: partial reduction in size of visible disease in some or all areas without any increase in visible disease.	Up to 6 months
Real-world Duration of Response (rwDOR)	rwDOR is defined as the time from the date of first rwCR or rwPR after treatment initiation to the date of the first noted occurrence of progressive disease or death. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.	Up to 6 months
Real-world Disease Control Rate (rwDCR)	rwDCR is defined as the percentage of participants who have a rwCR, rwPR, or real-world stable disease (rwSD) assessment during the course of a line of therapy, among all participants in that cohort. rwCR: complete resolution of disease, rwPR: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease, rwSD: no change in overall size of visible disease, or mixed response (some lesions increased, some lesions decreased).	Up to 6 months
Overall Survival (OS)	OS is defined as the time from the date of advanced disease diagnosis until the date of death. Participants for whom a date of death has not been identified, will be censored at the date of last contact available.	Up to 6 months
Real-world Time to Treatment Discontinuation (rwTTD)	rwTTD is defined as time from treatment initiation to treatment discontinuation for any reason. Treatment discontinuation is defined as the date of the last drug administered during the same treatment line of therapy or death, whichever occurs earlier. Participants are considered to discontinue treatment if they have advanced to a new line of therapy since the last drug administration, have a recorded date of death, or have no visit activity more than 120 days after the last drug administration.	Up to 6 months

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2022
• Primary Completion (Actual): February 13, 2023
• Study Completion (Actual): February 13, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Drug Therapy; NSCLC; Retrospective; Chart review; Mobocertinib; EGFR exon 20 NSCLC; Real World
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: TAK-788-4002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No