NCT03725475

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,111

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
10 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
26 days until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 5, 2020

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

October 22, 2018

Last Update Submit

October 1, 2020

Conditions

Keywords

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Progression-free survival (PFS)

    Up to 5 years

Other Outcomes (1)

  • Time to progression (TTP)

    Up to 5 years

Study Arms (1)

Stage III

stage III Non-small Cell Lung Cancer (NSCLC )

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

stage III non-small-cell lung cancer patients

You may qualify if:

  • 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
  • Adult male or female (≥18 years old or according to age of majority as defined by local regulations)
  • 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
  • Primary diagnosis of stage III NSCLC, confirmed by pathology, between 01 January 2013 and 31 December 2017
  • Available medical records

You may not qualify if:

  • 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
  • Patients initially diagnosed with stage I-II NSCLC who have progressed to stage III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Research Site

Buenos Aires, Argentina

Location

Research Site

Rosario, Argentina

Location

Research Site

Santiago, Chile

Location

Research Site

Cali, Colombia

Location

Research Site

Córdoba, Colombia

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Research Site

Medellín, Colombia

Location

Research Site

Santo Domingo, Dominican Republic

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Research Site

Anand, India

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Research Site

Bangalore, India

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Research Site

Calicut, India

Location

Research Site

Chennai, India

Location

Research Site

Mohali, India

Location

Research Site

Mumbai, India

Location

Research Site

Nashik, India

Location

Research Site

New Delhi, India

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Research Site

Odissa, India

Location

Research Site

Srinagar, India

Location

Research Site

West Bengal, India

Location

Research Site

Guadalajara, Mexico

Location

Research Site

Mexico City, Mexico

Location

Research Site

Toluca, Mexico

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Research Site

Lima, Peru

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan District, Taiwan

Location

Research Site

Bangkoknoi, Thailand

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Research Site

Dusit, Thailand

Location

Research Site

Pathumwan, Thailand

Location

Research Site

Ratchathewi, Thailand

Location

Research Site

Montevideo, Uruguay

Location

Related Publications (3)

  • Aboelhassan R, Sobeih ME, El-Din MA, Ghali RR, El-Din IS, Khorshid O, Mokhtar M, Rabea AM, Belal A, Azim HA, Abdullah M, Elnahas T, Tawfik H, Abdelwahab S, Elsaid AA, Hashem T, Mancy M, Farag H. Real-world treatment patterns and clinical outcomes in patients with stage III non-small cell lung cancer: results of KINDLE-Egypt cohort. Ther Adv Med Oncol. 2023 Nov 22;15:17588359231212182. doi: 10.1177/17588359231212182. eCollection 2023.

  • 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.

  • Martin CM, Puello-Guerrero A, Mas-Lopez LA, Campos-Gomez S, Orlando-Orlandi FJ, Tejado Gallegos LF, Huggenberger R. Real-world KINDLE-Latin America subset data on treatment patterns and clinical outcomes in patients with stage III non-small-cell lung cancer. Cancer Med. 2023 Jan;12(2):1247-1259. doi: 10.1002/cam4.4990. Epub 2022 Jul 4.

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 31, 2018

Study Start

November 26, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 5, 2020

Record last verified: 2020-09

Locations