Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
JAVELIN Lung 100
Clinical summary
Summary
The purpose of this study is to demonstrate superiority with regard to progression free survival (PFS) based on an Independent Review Committee (IRC) assessment of avelumab versus platinum-based doublet in non-small cell lung cancer (NSCLC) subjects with Programmed death ligand 1+ (PD-L1+) tumors.
Conditions
This trial is treating people with Non-Small Cell (NSC) Lung Cancer (PD-L1+ tumours)
Eligibility
Inclusion
- 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
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
EMD Serono
Scientific Title
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
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