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Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by EMD Serono ( EMD Serono Research & Development Institute, Inc. )
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )
ClinicalTrials.gov Identifier:
NCT02576574
First received: October 13, 2015
Last updated: September 14, 2017
Last verified: September 2017
October 13, 2015
September 14, 2017
October 29, 2015
July 25, 2019   (Final data collection date for primary outcome measure)
  • Progression Free Survival (PFS) in Subjects With High PD-L1 + Tumor Expression Based on an Independent Review Committee (IRC) Assessment According to RECIST 1.1 [ Time Frame: Time from date of randomization until PD or death, assessed up to 39 months ]
    PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) as determined by the independent review committee or death due to any cause in the absence of documented PD, whichever occurs first.
  • Overall Survival (OS) in Subjects With High PD-L1 + Tumor Expression [ Time Frame: Time from date of randomization until death, assessed up to 49 months ]
    The OS is defined as the time from randomization to the date of death, regardless of the actual cause of the subjects' death.
Progression Free Survival (PFS) [ Time Frame: Time from date of randomization until PD or death, assessed up to 2.5 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). 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.
Complete list of historical versions of study NCT02576574 on ClinicalTrials.gov Archive Site
  • Progression Free Survival (PFS) in Subjects With Moderate and High PD-L1 + Tumor Expression Based on an IRC Assessment According to RECIST 1.1 [ Time Frame: Time from date of randomization until PD or death, assessed up to 39 months ]
    PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) as determined by the independent review committee or death due to any cause in the absence of documented PD, whichever occurs first.
  • Overall Survival (OS) in Subjects With Moderate and High and any PD-L1 + Tumor Expression [ Time Frame: Time from date of randomization until death, assessed up to 49 months ]
    The OS is defined as the time from randomization to the date of death, regardless of the actual cause of the subjects death.
  • Best Overall Response (BOR) as Adjudicated by the IRC [ Time Frame: Time from date of randomization up to 39 months ]
    BOR will be determined according to RECIST 1.1. 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.
  • Duration of Response (DOR) According to RECIST 1.1 [ Time Frame: Time from date of randomization up to 39 months ]
    DOR will be determined according to RECIST 1.1, defined for each subject with a confirmed response as the time from the date of the first assessment demonstrating a CR or PR to date of the first assessment demonstrating PD or death within 12 weeks after the last tumor assessment, whichever occurs first. 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 49 months ]
    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 49 months ]
    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 49 months ]
    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 ]
    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.
  • Number of Subjects With Abnormalities in Safety Laboratory Tests as Graded by 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 ]
  • Number of Subjects With Abnormalities in Vital Signs, Physical Examination, and Eastern Cooperative Oncology Group (ECOG) PS. [ Time Frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug administration ]
  • Number of Subjects With Abnormalities in 12-lead ECG [ Time Frame: Screening and at the End-of-Treatment visit ]
  • Best Overall Response (BOR) [ Time Frame: Time from date of randomization up to 2.5 years ]
    BOR will be determined according to RECIST 1.1 and as adjudicated by an IRC. 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.
  • Overall Survival (OS) [ Time Frame: Time from date of randomization until death, assessed up to 2.5 years ]
    The OS is defined as the time from randomization to death due to any cause.
  • Change From Baseline in European Quality Of Life 5-dimensions (EQ-5D-5L) Health Outcome Questionnaire [ Time Frame: Baseline up to 2.5 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 2.5 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 2.5 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 ]
    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.
Not Provided
Not Provided
 
Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)
A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer
The purpose of this study is to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
First Line Non-Small Cell Lung Cancer
  • Drug: Avelumab
    Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.
    Other Names:
    • Anti-PD-L1
    • MSB0010718C
  • Drug: Pemetrexed
    Pemetrexed 500 mg per square meter (mg/m^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
  • Drug: Paclitaxel
    Paclitaxel 200 mg/m^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
  • Drug: Gemcitabine
    Gemcitabine 1250 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.
  • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.
  • Drug: Carboplatin
    Carboplatin AUC 5 mg/mL*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.
  • Drug: Cisplatin
    Cisplatin 75 mg/m^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
  • Drug: Carboplatin
    Carboplatin AUC 6 mg/mL*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.
  • Drug: Avelumab
    Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once a week for 12 weeks and then once every 2 weeks until disease progression or unacceptable toxicities.
    Other Names:
    • Anti-PD-L1
    • MSB0010718C
  • Experimental: Arm A: Avelumab
    Intervention: Drug: Avelumab
  • Active Comparator: Arm B: Platinum-containing chemotherapy regimen

    Platinum-containing chemotherapy regimen: Investigator's choice platinum containing chemotherapy regimen to be administered consisting of one of the following:

    Non-squamous tumor histology

    Pemetrexed (500 mg/m^2) +cisplatin (75 mg/m^2) or carboplatin (AUC 6 mg/mL*min)

    Squamous tumor histology

    Paclitaxel (200 mg/m^2) +carboplatin (AUC 6 mg/mL*min)

    Gemcitabine (1250 mg/m^2)+ cisplatin (75 mg/m^2)

    Gemcitabine (1000 mg/m^2 )+carboplatin (AUC 5 mg/mL*min)

    Interventions:
    • Drug: Pemetrexed
    • Drug: Paclitaxel
    • Drug: Gemcitabine
    • Drug: Gemcitabine
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Carboplatin
  • Experimental: Arm C: Avelumab
    Intervention: Drug: Avelumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1095
July 26, 2024
July 25, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged greater than or equal to (>=) 18 years
  • With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
  • At least 1 measurable tumor lesion
  • With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
  • With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
  • Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
  • Other protocol defined criteria could apply

Exclusion Criteria:

  • Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
  • Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
  • Known severe hypersensitivity reactions to monoclonal antibodies (Grade >= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade > 1 NCI-CTCAE v 4.03.
  • Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of <= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
  • Other protocol defined criteria could apply
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: US Medical Information 888-275-7376
Contact: Merck KGaA Communication Center 49 6151 72 5200 service@merckgroup.com
Australia,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   Estonia,   France,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
Czech Republic,   Germany
 
NCT02576574
EMR 100070-005
2015-001537-24 ( EudraCT Number )
Yes
Not Provided
Not Provided
EMD Serono ( EMD Serono Research & Development Institute, Inc. )
EMD Serono Research & Development Institute, Inc.
Merck KGaA
Study Director: Medical Responsible EMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
EMD Serono
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP