Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
NCT02679170
ABOUT THIS STUDY
FOR MORE INFORMATION
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- Patients with Advanced or metastatic non-small cell lung cancer
- Patients who will be screened for anaplastic lymphoma kinase (ALK) rearrangement
- Age > 18 years
- For the patients that will be recruited prospectively: Patients must have a signed informed consent document.
- For the treatment sub-study, patients must also meet the following criteria
- Confirmed anaplastic lymphoma kinase (ALK)-positive tumour
- Patients treated with crizotinib under routine clinical practice
- Patients with a minimum data registered at the medical history
For the ROS1 treatment sub-study:
- Confirmation of NSCLC with ROS1-positive translocation
- Have been eligible to receive treatment with crizotinib according to routine clinical practice since the market launch of the ROS1 indication in Spain on 8 February 2017 until the opening of the site.
- Patients should have a predetermined minimum amount of data recorded in their medical records.
- Any patient who does not meet any of the inclusion criteria defined in the previous
section, depending on the sub-study for which they are included.
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Descriptive Information | |||||
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Brief Title | Study to IDEntify Patients With Advanced/Metastatic Non Small Cell Lung Cancer (NSCLC) and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS) | ||||
Official Title | Prospective Observational Study to IDEntify Patients With Advanced/Metastatic NSCLC and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS) | ||||
Brief Summary | Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS) | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Other | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | NSCLS Patients, ALK + Confirmed, ROS1 translocation confirmed | ||||
Condition | Non-Small Cell Lung Cancer | ||||
Intervention | Drug: Crizotinib
Treatment with crizotinib following routine clinical practice | ||||
Study Groups/Cohorts | Routine clinical practice group (NSCLC ALK+, ROS1)
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1 Intervention: Drug: Crizotinib | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment | 100 | ||||
Original Estimated Enrollment | 1 | ||||
Estimated Study Completion Date | March 31, 2022 | ||||
Estimated Primary Completion Date | March 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
For the ROS1 treatment sub-study:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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Listed Location Countries | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02679170 | ||||
Other Study ID Numbers | A8081057 IDEALKROS ( Other Identifier: Alias Study Number ) IDEALK ( Other Identifier: Alias Study Number ) | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | March 2021 |