Trial · NCT02679170
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | 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) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to the Origin of Tumor Sample | 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) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | 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) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Histological Subtype of Tumor | 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) | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | 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) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) | Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed in ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 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 | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) | Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study | At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study) | Analysis population included all participants presented an evaluable test for ALK translocation. This outcome measure was planned to be analyzed for ALK incidence sub-study only. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 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) | For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Months | MEDIAN |
| PRIMARY | Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 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) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Percentage of participants | NUMBER |
| PRIMARY | Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | 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) | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 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) | For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Months | MEDIAN |
| PRIMARY | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | 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) | Safety population included all participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all the study screening criteria and had received at least one dose of treatment with crizotinib. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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