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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)

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Pfizer

Status

Completed

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: Crizotinib

Study type

Observational

Funder types

Industry

Identifiers

NCT02679170
A8081057
IDEALKROS (Other Identifier)
IDEALK (Other Identifier)

Details and patient eligibility

About

Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS)

Enrollment

692 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For ALK Incidence substudy

  • 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 ALK treatment substudy (retrospective and prospective)
  • Age > 18 years
  • 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 patients that will be recruited prospectively: Patients must have a signed informed consent document.

For the ROS1 treatment sub-study (retrospective only):

  • Age > 18 years
  • 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.

Exclusion criteria

  • 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.

Trial design

692 participants in 1 patient group

Routine clinical practice group (NSCLC ALK+, ROS1)
Description:
Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1
Treatment:
Drug: Crizotinib

Trial documents
2

Trial contacts and locations

32

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Data sourced from clinicaltrials.gov

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