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)
Verified date | June 2022 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS)
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Spain,
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 |
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