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

October 1, 2020 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

3111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Chile
      • Santiago de Chile, Chile
        • Research Site
  • Colombia
      • Cali, Colombia
        • Research Site
      • Cordoba, Colombia
        • Research Site
      • Medellin, Colombia
        • Research Site
  • Dominican Republic
      • Santo Domingo, Dominican Republic
        • Research Site
  • India
      • 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
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • Toluca, Mexico
        • Research Site
  • Peru
      • Lima, Peru
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • TaoYuan, Taiwan
        • Research Site
  • Thailand
      • Bangkoknoi, Thailand
        • Research Site
      • Dusit, Thailand
        • Research Site
      • Pathumwan, Thailand
        • Research Site
      • Ratchathewi, Thailand
        • Research Site
  • Uruguay
      • Montevideo, Uruguay
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

stage III non-small-cell lung cancer patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 26, 2018

Primary Completion (ACTUAL)

September 30, 2019

Study Completion (ACTUAL)

September 30, 2019

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 29, 2018

First Posted (ACTUAL)

October 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D133HR00004 (OTHER: AstraZeneca)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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