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
- Conditions
- Non-small cell lung cancer10038666
- Registration Number
- NL-OMON47625
- Lead Sponsor
- Merck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 3
Male or female subjects * 18 years, with an ECOG PS of 0 to 1 at trial entry,
with the availability of a formalinfixed, paraffin-embedded block containing
tumor tissue or 7 (preferably 10) unstained tumor slides with PD-L1+, at least
1 measurable tumor lesion, and with histologically confirmed metastatic or
recurrent NSCLC. Subjects must not have received any treatment for systemic
lung cancer, and have an estimated life expectancy of more than 12 weeks.
Subjects whose disease harbors an activating EGFR mutation, or with
non-squamous cell NSCLC whose disease harbors and 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 enrollment, subjects must be either off steroids or on a stable or
decreasing dose of <10mg daily prednisone (or equivalent), do not require
steroid maintenance therapy, and do
not have ongoing neurological symptoms that are related to the brain
localization of the disease.
Other protocol defined criteria could apply.
All potential exceptions must be discussed with the study Medical Monitor prior
to enrollment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival time, defined as the time from date of randomization<br /><br>until date of the first documentation of PD or<br /><br>death due to any cause in the absence of documented PD, whichever occurs first</p><br>
- Secondary Outcome Measures
Name Time Method <p>- PFS time in PD L1++ ITT subjects,<br /><br>- Best Overall Response according to RECIST 1.1 and as adjudicated by the IRC,<br /><br>- Overall Survival time (defined as the time from randomization to the date of<br /><br>death),<br /><br>- Changes in Subject-reported Outcomes/Quality of life (assessed by the EQ-5D,<br /><br>and the EORTC QLQ-C30, and module<br /><br>QLQ-LC13 questionnaires)</p><br>