Clinical trial NCT02679170: 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: Observational Study to IDEntify Patients With Advanced/Metastatic NSCLC and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: ALK+, ROS1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-10
Enrollment: 692
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NSCLC Patients, ALK +translocation confirmed, ROS1+translocation confirmed

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)


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.

Primary outcomes:
measure: Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only
timeFrame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
measure: Number of Participants Classified According to the Origin of Tumor Sample
timeFrame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)
measure: Number of Participants Classified According to Type of Sample Collected for Tumor Analysis
timeFrame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis)
measure: Number of Participants Classified According to Histological Subtype of Tumor
timeFrame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease)
measure: Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study
timeFrame: At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease)
measure: Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
timeFrame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
measure: Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
timeFrame: At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease)
measure: Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
timeFrame: At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease)
measure: Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
timeFrame: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study
timeFrame: From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study
timeFrame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
measure: 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
timeFrame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
measure: Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study
timeFrame: At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)
measure: Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
timeFrame: From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
timeFrame: From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study
timeFrame: From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study
timeFrame: From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
measure: Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study
timeFrame: From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Univ. de Santiago de Compostela
state: A Coruña
city: Alcoi
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Jerez de la Frontera
country: Spain
facility: Complejo Hospitalario de Jerez
state: Cadiz
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
state: Cantabria
city: Alcázar de San Juan
country: Spain
facility: Hospital General Mancha Centro
state: Ciudad REAL
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
state: LAS Palmas
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaia
city: Albacete
country: Spain
facility: Hospital Universitario de Albacete
city: Barcelona
country: Spain
facility: Hospital Universitario Clinic i Provincial
city: Burgos
country: Spain
facility: Hospital Universitario de Burgos
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar, Cádiz
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular Materno-Infantil
city: León
country: Spain
facility: Hospital Universitario de León
city: Logroño
country: Spain
facility: Hospital Universitario San Pedro, Logroño
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti (HULA_ Lugo)
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: H.U. La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Murcia
country: Spain
facility: Hospital Universitario Arrixaca
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense (CHUOU)
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma de Mallorca
country: Spain
facility: HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de la Candelaria, Tenerife
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Vigo
country: Spain
facility: Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Aguado de la Rosa C, Cruz Castellanos P, Lazaro-Quintela M, Domine M, Vazquez Estevez S, Lopez-Vivanco G, Firvida Perez JL, Alonso Romero JL, Ferrera Delgado L, Garcia Giron C, Diz Tain P, Alvarez Alvarez R, Mut Sanchis P, Fernandez Canton I, Manrique Abos I, Martinez Aguillo M, Gomez-Aldaravi Gutierrez L, Ortega Granados AL, Alvarez Cabellos R, Garcia Sebastian A, Garcia Sifuentes LF, Reguart N. Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study). Lung Cancer. 2022 Nov;173:83-93. doi: 10.1016/j.lungcan.2022.09.010. Epub 2022 Sep 19.