A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
Condition: Adenocarcinoma of the Lung
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: Farletuzumab; Placebo; Carboplatin; Paclitaxel; Pemetrexed; Cisplatin
Intervention description: Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.
Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression.; Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.
Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression.; Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6].; Paclitaxel 200 mg/m^2 will be administered intravenously.; Pemetrexed 500 mg/m^2 will be administered intravenously.; Cisplatin 75 mg/m^2 will be administered intravenously.
Intervention MeSH terms: Paclitaxel; Carboplatin; Pemetrexed; Farletuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare the effect of farletuzumab versus placebo
      in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent
      (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on
      investigator-assessed progression free survival (PFS) as determined by Response Evaluation
      Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new
      occurrence of positive fluid cytology) in chemotherapy naive participants with folate
      receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the lung classified as
             stage IV

          -  Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)

          -  Measurable disease with at least one unidimensionally measurable lesion according to
             RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging
             (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the
             first dose of farletuzumab or placebo)

          -  Must have received no prior chemotherapy, radiation therapy or surgery with curative
             intent for adenocarcinoma of the lung

        Exclusion Criteria:

          -  Participants who have had previous chemotherapy for adenocarcinoma of the lung

          -  Prior surgery with curative intent for adenocarcinoma of the lung

          -  Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local
             radiotherapy for symptom control [i.e., palliative radiation with non-curative intent]
             is permitted)