Avelumab in First-line NSCLC (JAVELIN Lung 100)
Condition: First Line Non-Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Avelumab; Pemetrexed; Paclitaxel; Gemcitabine; Gemcitabine; Carboplatin; Cisplatin; Carboplatin; Avelumab Weekly
Intervention description: Participants received Avelumab at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour (-10/+20 minutes) intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.; Participants received Pemetrexed 500 milligrams 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.; Participants received 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.; Participants received 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.; Participants received 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.; Participants received Carboplatin area under concentration curve (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.; Participants received 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.; 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.; Participants received Avelumab at a dose of 10 mg/kg as a 1-hour (-10/+20 minutes) IV infusion every week for 12 consecutive weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin; Gemcitabine; Pemetrexed; Avelumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1214.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Avelumab; MSB0010718C; Non-Small Cell Lung Cancer

Summary:

      The purpose of this study was 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) participants
      with Programmed death ligand 1+ (PD-L1+) tumors.
    

Eligibility criteria:

        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