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

NCT ID: NCT03725475

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-26

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Non-small-cell Lung Cancer (NSCLC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Stage III

stage III Non-small Cell Lung Cancer (NSCLC )

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Buenos Aires, , Argentina

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Rosario, , Argentina

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Santiago, , Chile

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Cali, , Colombia

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Córdoba, , Colombia

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Medellín, , Colombia

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Santo Domingo, , Dominican Republic

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Anand, , India

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Bangalore, , India

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Calicut, , India

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Chennai, , India

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Mohali, , India

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Mumbai, , India

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Nashik, , India

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New Delhi, , India

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Odissa, , India

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Srinagar, , India

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West Bengal, , India

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Toluca, , Mexico

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Lima, , Peru

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkoknoi, , Thailand

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Dusit, , Thailand

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Pathumwan, , Thailand

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Ratchathewi, , Thailand

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Montevideo, , Uruguay

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Countries

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Argentina Chile Colombia Dominican Republic India Mexico Peru Taiwan Thailand Uruguay

References

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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.

Reference Type DERIVED
PMID: 38028146 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36119641 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35789068 (View on PubMed)

Other Identifiers

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D133HR00004

Identifier Type: OTHER

Identifier Source: secondary_id

D133HR00004

Identifier Type: -

Identifier Source: org_study_id

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