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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725475
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease
Non-small-cell Lung Cancer (NSCLC)

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.

Study Design
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Study Type : Observational
Actual Enrollment : 3111 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort
Stage III
stage III Non-small Cell Lung Cancer (NSCLC )


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
    The length of time from stage III NSCLC diagnosis (index date) or time of therapy initiation to death due to any cause.


Secondary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 5 years ]
    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.


Other Outcome Measures:
  1. Time to progression (TTP) [ Time Frame: Up to 5 years ]
    The length of time from time of therapy initiation to disease progression (as available in the medical record).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
stage III non-small-cell lung cancer patients
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725475


Locations
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Argentina
Research Site
Buenos Aires, Argentina
Research Site
Rosario, Argentina
Chile
Research Site
Santiago de Chile, Chile
Colombia
Research Site
Cali, Colombia
Research Site
Cordoba, Colombia
Research Site
Medellin, Colombia
Dominican Republic
Research Site
Santo Domingo, Dominican Republic
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, India
Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico City, Mexico
Research Site
Toluca, Mexico
Peru
Research Site
Lima, Peru
Taiwan
Research Site
Kaohsiung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
TaoYuan, Taiwan
Thailand
Research Site
Bangkoknoi, Thailand
Research Site
Dusit, Thailand
Research Site
Pathumwan, Thailand
Research Site
Ratchathewi, Thailand
Uruguay
Research Site
Montevideo, Uruguay
Sponsors and Collaborators
AstraZeneca
More Information
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Additional Information:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03725475    
Other Study ID Numbers: D133HR00004
D133HR00004 ( Other Identifier: AstraZeneca )
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms