Avelumab in Non-Small Cell Lung Cancer (JAVELIN Lung 200)
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|ClinicalTrials.gov Identifier: NCT02395172|
Recruitment Status : Active, not recruiting
First Posted : March 20, 2015
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Drug: Avelumab Drug: Docetaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Docetaxel in Subjects With Non-small Cell Lung Cancer That Has Progressed After a Platinum-containing Doublet|
|Actual Study Start Date :||March 31, 2015|
|Primary Completion Date :||November 22, 2017|
|Estimated Study Completion Date :||January 16, 2023|
Subjects will receive 10 milligram per kilogram (mg/kg) of avelumab as a 1-hour intravenous (IV) infusion once every 2 weeks.
|Active Comparator: Docetaxel||
Subjects will receive 75 mg per square meter (m^2) (per label) of docetaxel by IV infusion once every 3 weeks.
- Overall survival (OS) time [ Time Frame: Time from date of randomization until death, assessed up to 7.6 years ]The OS is defined as the time from randomization to death due to any cause.
- Progression-Free Survival (PFS) Time [ Time Frame: Time from date of randomization until progressive disease or death, assessed up to 6.5 years ]PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PFS will be assessed as per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) as adjudicated by independent endpoint review committee (IERC). PD is defined as at least a 20 percent (%) increase in the sum of longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
- Best Overall Response (BOR) [ Time Frame: Time from date of randomization up to 6.5 years ]BOR will be determined according to RECIST 1.1 and as adjudicated by an IERC. BOR is defined as the best response of any of the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from the date of randomization until disease progression or recurrence (taking the smallest measurement recorded since the start of treatment as reference). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Stable disease (SD)=Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD is defined as at least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
- Change from baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire [ Time Frame: Baseline up to 6.5 years ]The EQ-5D-5L Health Outcome Questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The EQ-5D-5L defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 (unable to walk, unable to self-care, unable to do usual activities, extreme pain or discomfort, extreme anxiety or depression) and the highest is 1.00 (no problems in all 5 dimensions).
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status [ Time Frame: Baseline up to 6.5 years ]EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer subjects. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
- Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) [ Time Frame: Baseline up to 6.5 years ]EORTC QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprises 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, neuropathy, alopecia, and medicine for pain). Score range: 0 (no burden of symptom domain or single symptom item) to 100 (highest burden of symptoms for symptom domains and single items).
- Number of subjects with Treatment-Emergent Adverse Events (TEAEs) according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 [ Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration, assessed up to 6.5 years ]TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 30 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395172
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|Study Director:||Medical Responsible||EMD Serono Inc., a business of Merck KGaA, Darmstadt, Germany|