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)

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT02679170

Acronym / sponsor ID

A8081057

Conditions

Non-Small Cell Lung Cancer

Keywords

ALK+, ROS1

Study type

Observational

Recruitment status

Completed

Enrolment

692 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

29 Jun 2016 (actual)

Primary completion

4 May 2022 (actual)

Study completion

4 May 2022 (actual)

First posted

10 Feb 2016 (estimated)

Results

Posted 9 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Cohort

Time perspective

Other

Number of arms

1

Who may qualify

Ages

19 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only

   Time frame: 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)

   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.

2. Number of Participants Classified According to the Origin of Tumor Sample

   Time frame: 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 the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure.

3. Number of Participants Classified According to Type of Sample Collected for Tumor Analysis

   Time frame: 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 the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure.

4. Number of Participants Classified According to Histological Subtype of Tumor

   Time frame: 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 the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified [NOS], other) were reported in this outcome measure.

5. Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study

   Time frame: 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)

   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.

6. Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

   Time frame: 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 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.

7. Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

   Time frame: 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 location of metastases were reported in this outcome measure. One participant may have more than one site of metastases.

8. Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

   Time frame: 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 classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure.

9. Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

   Time frame: 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 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.

10. Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study

    Time frame: 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)

    The number of participants classified as dead or alive were reported in this outcome measure.

11. Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study

    Time frame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)

    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.

12. 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

    Time frame: Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months)

    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.

13. Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study

    Time frame: At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study)

    The percentage of participants with ALK positive translocations were reported in this outcome measure.

14. Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

    Time frame: 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)

    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.

15. Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

    Time frame: 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)

    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.

16. Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study

    Time frame: 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)

    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.

17. Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study

    Time frame: 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)

    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.

18. Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study

    Time frame: 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)

    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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 36162227Aguado 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.
• To obtain contact information for a study center near you, click here.Link provided by the sponsor.
• Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

32 sites in 1 country: see every site and its status.