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)

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

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

Study Overview

• Status: Completed
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Crizotinib

• Study Type: Observational
• Enrollment (Actual): 692

Contacts and Locations

Study Locations

• Spain
  • Albacete, Spain, 02006
    • Hospital Universitario de Albacete
  • Barcelona, Spain, 08036
    • Hospital Universitario Clinic i Provincial
  • Burgos, Spain, 09006
    • Hospital Universitario de Burgos
  • Cadiz, Spain, 11009
    • Hospital Universitario Puerta del Mar, Cádiz
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen
  • Las Palmas de Gran Canaria, Spain, 35016
    • Complejo Hospitalario Universitario Insular Materno-Infantil
  • León, Spain, 24080
    • Hospital Universitario de Leon
  • Logroño, Spain, 26006
    • Hospital Universitario San Pedro, Logroño
  • Lugo, Spain, 27003
    • Hospital Universitario Lucus Augusti (HULA_ Lugo)
  • Madrid, Spain, 28040
    • Hospital Universitario Fundacion Jimenez Diaz
  • Madrid, Spain, 28006
    • Hospital Universitario De La Princesa
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Maranon
  • Madrid, Spain, 28046
    • H.U. La Paz
  • Malaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
  • Murcia, Spain, 30120
    • Hospital Universitario Arrixaca
  • Orense, Spain, 32005
    • Complejo Hospitalario Universitario de Ourense (CHUOU)
  • Oviedo, Spain, 33011
    • Hospital Universitario Central de Asturias
  • Palma de Mallorca, Spain, 07198
    • HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Universitario de la Candelaria, Tenerife
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Toledo, Spain, 45004
    • Hospital Virgen de la Salud
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Vigo, Spain, 36312
    • Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15076
      • Hospital Clínico Univ. de Santiago de Compostela
  • Alicante
    • Alcoi, Alicante, Spain, 03804
      • Hospital Virgen de los Lirios
  • Cadiz
    • Jerez de la Frontera, Cadiz, Spain, 11407
      • Complejo Hospitalario de Jerez
  • Cantabria
    • Santander, Cantabria, Spain, 9008
      • Hospital Marques de Valdecilla
  • Ciudad REAL
    • Alcázar de San Juan, Ciudad REAL, Spain, 13600
      • Hospital General Mancha Centro
  • LAS Palmas
    • Las Palmas de Gran Canaria, LAS Palmas, Spain, 35010
      • Hospital Universitario de Gran Canaria Dr. Negrin
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Universitario de Navarra
  • Vizcaia
    • Barakaldo, Vizcaia, Spain, 48903
      • Hospital Universitario Cruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

NSCLC Patients, ALK +translocation confirmed, ROS1+translocation confirmed

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Routine clinical practice group (NSCLC ALK+, ROS1); Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1	Drug: Crizotinib; Treatment with crizotinib following routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only	ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure.	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)
Number of Participants Classified According to the Origin of Tumor Sample	Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure.	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)
Number of Participants Classified According to Type of Sample Collected for Tumor Analysis	Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure.	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)
Number of Participants Classified According to Histological Subtype of Tumor	Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified [NOS], other) were reported in this outcome measure.	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)
Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study	Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread >10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure.	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)
Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure.	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)
Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases.	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)
Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure.	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)
Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure.	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)
Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study	The number of participants classified as dead or alive were reported in this outcome measure.	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)
Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study	QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening.	Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
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	QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer & treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, & medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating.	Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)
Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study	The percentage of participants with ALK positive translocations were reported in this outcome measure.	At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)
Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up.	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)
Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria.	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)
Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study	Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed.	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)
Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study	Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive.	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)
Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study	An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Duration of treatment_ALK substudy	Period of time with Crizotinib treatment	2 years
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
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
Clinical characteristics	To describe the clinical characteristics of patients with ROS 1 translocation	2 years
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
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
Duration of treatment_ROS1 substudy	Period of time with Crizotinib treatment	2 years
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
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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2016
• Primary Completion (Actual): May 4, 2022
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 5, 2016
• First Posted (Estimated): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: ALK+, ROS1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Tyrosine Kinase Inhibitors; Crizotinib
• Other Study ID Numbers: A8081057; IDEALKROS (Other Identifier: Alias Study Number); IDEALK (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.