Non-small Cell Lung Cancer MetastaticNCT03424980
A Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors
An observational study of Non-small Cell Lung Cancer Metastatic, run by Tang-Du Hospital at 5 sites in China.
Trial summary
This is a real-world non-interventional observational study. The study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer Metastatic
- What is being tested?
- Tyrosine kinase inhibitors
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 31 Dec 2017to 30 Apr 2018
- 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
- Child, Adult, Older adult
Study population: The target study population is defined as the patients who were diagnosed with advanced non-small cell lung cancer (NSCLC) with brain metastases and were treated with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors following real-world clinical practice and experiences of clinical physicians
Who may be able to join
- The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017
- The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);
- The patients who are observed with brain metastases diagnosed by imaging methods;
- The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;
- The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;
Who cannot join
- No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Yang Liu, PhD, 0086-13501009331, sunny301x@sina.com
Yang Liu, PhD
- Recruiting
Huaxi Hospital Affiliated to Sichuan University
Chengdu, Sichuan, 610041
Lunxun Liu, PhD, 0086-13608236600, lunxu_liu@aliyun.com
Lunxun Liu, PhD
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Heng Zhao, 0086-13701865603, h_zhao28@163.com
Heng Zhao, PhD
- Recruiting
Tongji Hospital Affiliated to Huazhong Technology Hospital
Wuhan, Hubei, 430030
Xiangning Fu, PhD, 0086-13607150390, Fuxn2006@aliyun.com
Xiangning Fu, PhD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yin Li, PhD, 0086-13903838752, liyin825@aliyun.com
Yin Li, PhD
About this study
Official title: A Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors (TKIs) in the Patients With Non-small Cell Lung Cancer Complicated With Brain Metastases
This is a real-world non-interventional observational study. The study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice.
Read the detailed description
This is a real-world non-interventional observational study that focuses to evaluate the effectiveness and safety of tyrosine kinase inhibitors (TKIs) in the patients of advanced non-small cell lung cancer (NSCLC) with brain metastases diagnosed by medical imaging methods. The patients with core medical health records who were enrolled in the clinics from 2014 to 2017 and were administered with TKIs only or combination therapies of TKIs will be included in the study. All the treatments followed real-world clinical practices and experiences of clinical physicians.
The effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. The safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. The mutation status of epidermal growth factor receptor (EGFR) and the type of anaplastic lymphoma kinase (ALK) will be assessed. All the study procedures will be in compliance with International Clinical Harmonization - Good Clinical Practice (ICH-GCP), standard operation procedures (SOPs), and regulatory policies/regulations.
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Being tested
- Tyrosine kinase inhibitors
- Keywords
- Non-small cell lung cancer, Chinese, brain metastases
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tyrosine kinase inhibitorsCombination product
Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Tyrosine kinase inhibitors | Diagnosed patients with advanced non-small cell lung cancer (NSCLC) with brain metastases who were administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors Receives: Combination Product: Tyrosine kinase inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who are not observed with the event of objective remission
Percentage of patients who are not observed with the event of objective remission
Measured: 2013 - 2017
Secondary outcomes (1)
Percentage of patients who are not observed with the event of disease progression
Percentage of patients who are not observed with the event of disease progression
Measured: 2013 - 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start31 Dec 2017
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, Zhang Helong, Tang-Du Hospital
- Investigators
- Helong Zhang, Principal investigator, Xi'an Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424980
- Sponsor's protocol ID
- W-TONG03
- Status last verified
- Feb 2018
- First submitted
- 18 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Non-interventional Observational Study to Evaluate Effectiveness and Safety of Tyrosine Kinase Inhibitors (TKIs) in the Patients With Non-small Cell Lung Cancer Complicated With Brain Metastases
- ClinicalTrials.gov ID
- NCT03424980
- Acronym / sponsor ID
- W-TONG03
- Conditions
- Non-small Cell Lung Cancer Metastatic
- Keywords
- Non-small cell lung cancer, Chinese, brain metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 31 Dec 2017 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 7 Feb 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 is a real-world non-interventional observational study. The study was designed to evaluate the effectiveness and safety of clinical treatments in the patients with advanced non-small cell lung cancer (NSCLC) complicated with brain metastases in clinical practice.
Detailed description
This is a real-world non-interventional observational study that focuses to evaluate the effectiveness and safety of tyrosine kinase inhibitors (TKIs) in the patients of advanced non-small cell lung cancer (NSCLC) with brain metastases diagnosed by medical imaging methods. The patients with core medical health records who were enrolled in the clinics from 2014 to 2017 and were administered with TKIs only or combination therapies of TKIs will be included in the study. All the treatments followed real-world clinical practices and experiences of clinical physicians.
The effectiveness will be measured by the treatment effects on brain metastases (objective remission rate) and overall survival/progress-free survival. The safety will be evaluated by adverse events, serious adverse events, laboratory tests, electrocardiogram, vital sign, and physical examination. The mutation status of epidermal growth factor receptor (EGFR) and the type of anaplastic lymphoma kinase (ALK) will be assessed. All the study procedures will be in compliance with International Clinical Harmonization - Good Clinical Practice (ICH-GCP), standard operation procedures (SOPs), and regulatory policies/regulations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tyrosine kinase inhibitors | – | Combination Product: Tyrosine kinase inhibitorsDiagnosed patients with advanced non-small cell lung cancer (NSCLC) with brain metastases who were administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The target study population is defined as the patients who were diagnosed with advanced non-small cell lung cancer (NSCLC) with brain metastases and were treated with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors following real-world clinical practice and experiences of clinical physicians
Key inclusion criteria (5 listed)
- The patients were treated with lung cancer and were enrolled from Jan 2013 to Jun 2017
- The patients with advanced (Clinical stage: Phase IV) non-small cell lung cancer who have complete core health medical records (HMRs);
- The patients who are observed with brain metastases diagnosed by imaging methods;
- The patients who have complete clinical data for diagnosis time of brain metastases, and overall survival/effectiveness;
- The patients who are administered with tyrosine kinase inhibitors only or combination therapies of tyrosine kinase inhibitors;
Key exclusion criteria (1 listed)
- No exclusion criteria are included in the study given that the study is designed as non-interventional and all the treatments followed real-world clinical practice and experiences of clinical physicians.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tyrosine kinase inhibitorsTyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors | Combination product | Tyrosine kinase inhibitors |
Primary outcome
Percentage of patients who are not observed with the event of objective remission
Time frame: 2013 - 2017
Percentage of patients who are not observed with the event of objective remission
1 secondary outcome
Percentage of patients who are not observed with the event of disease progression
Time frame: 2013 - 2017
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Non-small Cell Lung Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Helong Zhang principal investigator
Xi'an Tangdu Hospital
5 sites in 1 country: 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 Metastatic, run by Tang-Du Hospital at 5 sites in China.
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 1 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: status not confirmed, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haiying Yang, MD/PhD (0086-10-62680809, celineyang@linkdoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who are not observed with the event of objective remission (time frame: 2013 - 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2018.