A Study to Reveal the Patient Characteristics and Treatment Patterns of Stage III Non-small-cell Lung Cancer Patients

Non-small-cell Lung Cancer (NSCLC) Clinical Trial

— KINDLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725475
• Other study ID #: D133HR00004
• Secondary ID: D133HR00004
• Status: Completed
• Start date: November 26, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: September 2020
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3111
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small-cell Lung Cancer (NSCLC)

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Rosario
Chile	Research Site	Santiago de Chile
Colombia	Research Site	Cali
Colombia	Research Site	Cordoba
Colombia	Research Site	Medellin
Dominican Republic	Research Site	Santo Domingo
India	Research Site	Anand
India	Research Site	Bangalore
India	Research Site	Calicut
India	Research Site	Chennai
India	Research Site	Mohali
India	Research Site	Mumbai
India	Research Site	Nashik
India	Research Site	New Delhi
India	Research Site	Odissa
India	Research Site	Srinagar
India	Research Site	West Bengal
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico City
Mexico	Research Site	Toluca
Peru	Research Site	Lima
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Taipei
Taiwan	Research Site	TaoYuan
Thailand	Research Site	Bangkoknoi
Thailand	Research Site	Dusit
Thailand	Research Site	Pathumwan
Thailand	Research Site	Ratchathewi
Uruguay	Research Site	Montevideo

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Dominican Republic,  India,  Mexico,  Peru,  Taiwan,  Thailand,  Uruguay, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to progression (TTP)	The length of time from time of therapy initiation to disease progression (as available in the medical record).	Up to 5 years
Primary	Overall survival (OS)	The length of time from stage III NSCLC diagnosis (index date) or time of therapy initiation to death due to any cause.	Up to 5 years
Secondary	Progression-free survival (PFS)	The length of time from time of therapy initiation to documented disease progression (as available in the medical record) or death due to any cause, whichever occurs first.	Up to 5 years

External Links

•   Redacted CSR synopsis