ALK positive Non-Small Cell Lung Cancer
Conditions
Brief summary
PFS defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first
Detailed description
intracranial PFS defined as time from randomization until CNS disease progression or death from any cause, OS is defined as the time from randomization until death from any cause, Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Patient reported NSCLC specific QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire: - Core 30 (QLQ-C30): Questionnaire consisting of 30 measuring subjects’ general cancer symptoms and functioning - 13-item Lung Cancer (QLQ-LC13) module: A complementary questionnaire measuring lung cancer symptoms and side-effects from conventional chemo- and radiotherapy
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial PFS defined as time from randomization until CNS disease progression or death from any cause, OS is defined as the time from randomization until death from any cause, Frequency and severity of adverse events graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, Patient reported NSCLC specific QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire: - Core 30 (QLQ-C30): Questionnaire consisting of 30 measuring subjects’ general cancer symptoms and functioning - 13-item Lung Cancer (QLQ-LC13) module: A complementary questionnaire measuring lung cancer symptoms and side-effects from conventional chemo- and radiotherapy | — |
Countries
Italy