Non-small-cell Lung Cancer (NSCLC)KINDLENCT03725475
A Study to Reveal the Patient Characteristics and Treatment Patterns of Stage III Non-small-cell Lung Cancer Patients
An observational study of Non-small-cell Lung Cancer (NSCLC), run by AstraZeneca at 32 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small-cell Lung Cancer (NSCLC)
- How many people
- 3,111 participants
- Where
- 32 sitesin 10 countries
- Study dates
- 26 Nov 2018to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: stage III non-small-cell lung cancer patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 10 countries.
32 sites in 10 countries
India11 sites
Research Site
Anand
Research Site
Bangalore
Research Site
Calicut
Research Site
Chennai
Research Site
Mohali
Research Site
Mumbai
Research Site
Nashik
Research Site
New Delhi
Research Site
Odissa
Research Site
Srinagar
Research Site
West Bengal
Taiwan5 sites
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan
Thailand4 sites
Research Site
Bangkoknoi
Research Site
Dusit
Research Site
Pathumwan
Research Site
Ratchathewi
Colombia3 sites
Research Site
Cali
Research Site
Córdoba
Research Site
Medellín
Mexico3 sites
Research Site
Guadalajara
Research Site
Mexico City
Research Site
Toluca
About this study
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
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.
Read the 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.
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Keywords
- Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stage III | stage III Non-small Cell Lung Cancer (NSCLC ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 years
Secondary outcomes (1)
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start26 Nov 2018
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,111 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725475
- Sponsor's protocol ID
- D133HR00004
- Other IDs
- D133HR00004
- Acronym
- KINDLE
- Status last verified
- Sep 2020
- First submitted
- 22 Oct 2018
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38028146Jazieh 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.
PubMed 36119641Martin 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.
PubMed 35789068
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03725475
- Acronym / sponsor ID
- KINDLE / D133HR00004
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Keywords
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,111 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stage III | – | –stage III Non-small Cell Lung Cancer (NSCLC ) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- stage III non-small-cell lung cancer patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Progression-free survival (PFS)
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 38028146Aboelhassan 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.
- Derived from this study: PubMed 36119641Jazieh 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.
- Derived from this study: PubMed 35789068Martin 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.
- Redacted CSR synopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small-cell Lung Cancer (NSCLC), run by AstraZeneca at 32 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in India, Taiwan, Thailand, Colombia, Mexico and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03725475, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.