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 Clinical Trial

Official title:

Observational Study to IDEntify Patients With Advanced/Metastatic NSCLC and ALK and ROS1 Translocation and to Establish Their Therapeutic Management (IDEALK&ROS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679170
• Other study ID #: A8081057
• Secondary ID: IDEALKROSIDEALK
• Status: Completed
• Start date: June 29, 2016
• Est. completion date: May 4, 2022

Study information

• Verified date: June 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: May 4, 2022
• Est. primary completion date: May 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• Crizotinib
Treatment with crizotinib following routine clinical practice

Locations

Country	Name	City	State
Spain	Hospital Universitario de Albacete	Albacete
Spain	Hospital General Mancha Centro	Alcázar de San Juan	Ciudad REAL
Spain	Hospital Virgen de los Lirios	Alcoi	Alicante
Spain	Hospital Universitario Cruces	Barakaldo	Vizcaia
Spain	Hospital Universitario Clinic i Provincial	Barcelona
Spain	Hospital Universitario de Burgos	Burgos
Spain	Hospital Universitario Puerta del Mar, Cádiz	Cadiz
Spain	Complejo Hospitalario de Jaen	Jaen
Spain	Complejo Hospitalario de Jerez	Jerez de la Frontera	Cadiz
Spain	Complejo Hospitalario Universitario Insular Materno-Infantil	Las Palmas de Gran Canaria
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas de Gran Canaria	LAS Palmas
Spain	Hospital Universitario de León	León
Spain	Hospital Universitario San Pedro, Logroño	Logroño
Spain	Hospital Universitario Lucus Augusti (HULA_ Lugo)	Lugo
Spain	H.U. La Paz	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Fundación Jimenez Diaz	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Malaga
Spain	Hospital Universitario Arrixaca	Murcia
Spain	Complejo Hospitalario Universitario de Ourense (CHUOU)	Orense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica	Palma de Mallorca
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de la Candelaria, Tenerife	Santa Cruz de Tenerife
Spain	Hospital Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Clínico Univ. de Santiago de Compostela	Santiago de Compostela	A Coruña
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Virgen de La Salud	Toledo
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Spain	Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of ALK-positive NSCLC in Spain	Real incidence of ALK-positive NSCLC in Spain	2 years
Primary	Progression Free Survival [PFS]	Efficacy in terms of PFS of Crizotinib in patients with advanced ALK+ and ROS1 translocation NSCLC	2 years
Secondary	ORR (Objective Response Rate)_ALK substudy	Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).; CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.	2 years
Secondary	Duration of Response (DR)_ALK substudy	Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7 (or 30.44 if in months). DR was calculated for the subgroup of participants with a confirmed objective tumor response. DR is usually categorized by the median with its 95% Confidence Interval (CI), range and 25% and 75% percentiles.	2 years
Secondary	Duration of treatment_ALK substudy	Period of time with Crizotinib treatment	2 years
Secondary	Overall Survival (OS) Rate_ALK substudy	Period from the first day of treatment until death or censored up to the last date on which it was known that the subject was alive.	2 years
Secondary	Number of Participants With Adverse Events (AEs) According to Seriousness_ALK substudy	Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	2 years
Secondary	Clinical characteristics	To describe the clinical characteristics of patients with ROS 1 translocation	2 years
Secondary	ORR (Objective Response Rate)_ROS 1 substudy	Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).; CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.	2 years
Secondary	Duration of Response (DR)_ROS1 substudy	Time in weeks/months from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR [which ever occurred first] that was subsequently confirmed plus 1) divided by 7 (or 30.44 if in months). DR was calculated for the subgroup of participants with a confirmed objective tumor response. DR is usually categorized by the median with its 95% Confidence Interval (CI), range and 25% and 75% percentiles.	2 years
Secondary	Duration of treatment_ROS1 substudy	Period of time with Crizotinib treatment	2 years
Secondary	Overall Survival (OS) Rate_Ros1substudy	Period from the first day of treatment until death or censored up to the last date on which it was known that the subject was alive.	2 years
Secondary	Number of Participants With Adverse Events (AEs) According to Seriousness_Ros1 substudy	Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	2 years

External Links

•   To obtain contact information for a study center near you, click here.