Clinical trial NCT03725475: A Study to Reveal the Patient Characteristics and Treatment Patterns of Stage III Non-small-cell Lung Cancer Patients
Official title: A Multi-country, Multi-centre, Observational, Retrospective Study to Reveal the Patient Characteristics, Disease Burden, Treatment Patterns and Patient Journey of Stage III Non-small-cell Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-small-cell Lung Cancer (NSCLC)
Keywords: Lung Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 3111
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: stage III non-small-cell lung cancer patients

Brief summary: This large multinational, non-interventional study (NIS), will retrospectively collect data derived from established medical records over a period of up to approximately 6 years (2013 to 2018), building a platform to capture and consolidate information on treatment patterns, Overall Survival (OS) and treatment effectiveness outcomes in the real-world setting.

Detailed description: This is multi-centre, multicountry, longitudinal cohort of patients with primary stage III NSCLC (Non-small Cell Lung Cancer), identified through the review of established patient medical records. Patients diagnosed with primary stage III NSCLC between 01 January 2013 and 31 December 2017 will be targeted for study inclusion, allowing at least 9 months of follow-up for living patients recruited at last day of the enrolment window. It is estimated that a total of approx. 2000 patients from 15-20 countries (approax.)

Patients' demographic and clinical characteristics and treatment patterns will be described. Clinical outcomes such as Progression-Free Survival (PFS), Time to Progression (TTP), Objective Response Rate (ORR) and Disease Control Rate (DCR) will be described by Line of Therapy (LOT). Overall survival will be described, where available. Healthcare resource utilisation will be described, as available from medical records.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent by the patient or next of kin/legal representative (for deceased patients at study entry, unless a waiver was granted), according to local regulations
2. Adult male or female (≥18 years old or according to age of majority as defined by local regulations)
3. First ever diagnosis of lung cancer (absence of previous diagnosis of lung cancer, including small cell lung cancer \[SCLC\] and NSCLC) in the patient's medical records
4. Primary diagnosis of stage III NSCLC, confirmed by pathology, between 01 January 2013 and 31 December 2017
5. Available medical records

Exclusion Criteria:

1. Patients with a concomitant cancer at the time of diagnosis of stage III NSCLC, except for non-metastatic non-melanoma skin cancers or in situ or benign neoplasms. A cancer will be considered concomitant if it occurs within 5 years of NSCLC diagnosis
2. Patients initially diagnosed with stage I-II NSCLC who have progressed to stage III

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years
Other outcomes:
measure: Time to progression (TTP)
timeFrame: Up to 5 years
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santiago de Chile
country: Chile
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Cordoba
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: Santo Domingo
country: Dominican Republic
facility: Research Site
city: Anand
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Calicut
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Mohali
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Nashik
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Odissa
country: India
facility: Research Site
city: Srinagar
country: India
facility: Research Site
city: West Bengal
country: India
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Toluca
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: TaoYuan
country: Taiwan
facility: Research Site
city: Bangkoknoi
country: Thailand
facility: Research Site
city: Dusit
country: Thailand
facility: Research Site
city: Pathumwan
country: Thailand
facility: Research Site
city: Ratchathewi
country: Thailand
facility: Research Site
city: Montevideo
country: Uruguay
facility: Research Site
Study officials:
References:
citation: Jazieh AR, Onal HC, Tan DS, Soo RA, Prabhash K, Kumar A, Huggenberger R, Cho BC. Real-world global data on targeting epidermal growth factor receptor mutations in stage III non-small-cell lung cancer: the results of the KINDLE study. Ther Adv Med Oncol. 2022 Sep 12;14:17588359221122720. doi: 10.1177/17588359221122720. eCollection 2022.