Clinical trial NCT05207423: A Chart Review Study of Adults With Advanced NSCLC
Official title: Patterns of Care and Clinical Outcomes of Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small Cell Lung Cancer (NSCLC)
Keywords: Drug Therapy
Retrospective
Chart review
NSCLC
Mobocertinib
EGFR exon 20 NSCLC
Real World
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-01-26
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Real-world Progression Free Survival (rwPFS)
timeFrame: Up to 6 months
measure: Real-world Overall Response Rate (rwORR)
timeFrame: Up to 6 months
measure: Confirmed Real-world Overall Response Rate (rwCORR)
timeFrame: Up to 6 months
measure: Real-world Duration of Response (rwDOR)
timeFrame: Up to 6 months
measure: Real-world Disease Control Rate (rwDCR)
timeFrame: Up to 6 months
measure: Overall Survival (OS)
timeFrame: Up to 6 months
measure: Real-world Time to Treatment Discontinuation (rwTTD)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: William Osler Health System
state: Ontario
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute.
state: Ontario
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Cancer Research Tower (PMCRT) The MaRS Centre, East Tower
state: Ontario
city: Saint-Quentin cedex
country: France
facility: Centre Hospitalier de Saint-Quentin
state: Aisne
city: Marseille
country: France
facility: Hopital Nord - CHU Marseille
state: Bouches-du-Rhone
city: Caen Cedex 05
country: France
facility: Centre Francois Baclesse
state: Calvados
city: Dijon Cedex
country: France
facility: Centre Georges Francois Leclerc
state: Cote-d'Or
city: Brest Cedex
country: France
facility: CHU Brest - Hopital Morvan
state: Finistere
city: Bordeaux cedex
country: France
facility: Institut Bergonie
state: Gironde
city: Toulouse
country: France
facility: Hopital Larrey
state: Haute Garonne
city: Pringy cedex
country: France
facility: Centre Hospitalier de la Region d'Annecy
state: Haute Savoie
city: Lille Cedex
country: France
facility: Hopital Albert Calmette - CHU Lille
state: Nord
city: Paris Cedex 05
country: France
facility: Institut Curie - site de Paris
state: Paris
city: Clermont Ferrand cedex
country: France
facility: CHU Clermont-Ferrand
state: Puy De Dome
city: Lyon
country: France
facility: Centre Leon Berard
state: Rhone
city: Lyon
country: France
facility: Hospices Civils de Lyon
state: Rhone
city: Strasbourg
country: France
facility: CHU Strasbourg - Nouvel Hopital Civil
state: Rhone
city: Saint-Pierre
country: France
facility: Centre Hospitalier Regional de la Reunion
state: Seine Saint Denis
city: Avignon
country: France
facility: Hospital Center Henri Duffaut
state: Vaculuse
city: Creteil Cedex
country: France
facility: Centre Hospitalier Intercommunal de Creteil
state: Val De Marne
city: Poitiers
country: France
facility: CHU Poitiers - Hopital la Miletrie
state: Vienne
city: Versailles
country: France
facility: Hopital de Versailles
state: Yvelines
city: Paris
country: France
facility: Hopital Tenon
city: Hong Kong
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Elizabeth Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: