N/A N=572

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)

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02679170 ↗

Enrolled (actual)

572

Serious AEs

24.1%

Results posted

Aug 2024

Primary outcome: Primary: Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only — 35; 11; 43; 29 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Crizotinib (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only	35; 11; 43; 29; 2; 2	—
PRIMARY Number of Participants Classified According to the Origin of Tumor Sample	409; 63; 28; 150; 28; 22	—
PRIMARY Number of Participants Classified According to Type of Sample Collected for Tumor Analysis	466; 75; 40; 27; 1; 5	—
PRIMARY Number of Participants Classified According to Histological Subtype of Tumor	453; 84; 44; 71; 1; 2	—
PRIMARY Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study	5; 1; 8; 7; 78; 42	—
PRIMARY Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	4; 14; 1; 0; 0; 1	—
PRIMARY Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	30; 16; 42; 18; 34; 14	—
PRIMARY Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	35; 14; 16; 5	—
PRIMARY Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	8; 2; 40; 20; 22; 12	—
PRIMARY Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	38; 25; 53; 25	—
PRIMARY Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study	8; 9; 4; 3; 10; 10	—
PRIMARY Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study	5; 9; 9; 8; 11; 5	—
PRIMARY Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study	31	—
PRIMARY Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	15.8; 7.5	—
PRIMARY Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	59.3; 48.9	—
PRIMARY Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study	13.5; 4.4	—
PRIMARY Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	46.5; 21.9	—
PRIMARY Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study	54; 33; 25; 9	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02679170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.