A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Ficlatuzumab; Erlotinib; placebo
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and
      safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with
      previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC
             (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer
             staging criteria).

          -  Measurable disease according to RECIST v.1.1.

          -  An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.

          -  BDX004 Positive Label.

          -  Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or
             biologic therapy for metastatic NSCLC. Subjects may have previously been treated with
             postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy
             for locally advanced disease provided this was completed at least 6 months prior to
             enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion
             Criteria

          -  History of severe allergic or anaphylactic reactions or hypersensitivity to
             recombinant proteins or excipients in the investigational agent or erlotinib.

          -  History of known brain metastases.

          -  Prior treatment with any other investigational drug or biologic agent within 5 half
             lives prior to randomization, or any investigational device within 2 weeks prior to
             randomization.

          -  Any unresolved toxicity from previous radiation therapy.

          -  Significant cardiovascular disease, including:

               -  Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left
                  ventricular ejection fraction of less than 55%.

               -  Cardiac failure New York Heart Association class III or IV.

               -  Myocardial infarction, severe or unstable angina within 6 months prior to
                  randomization.

               -  History of serious ventricular arrhythmia (ie, ventricular tachycardia or
                  ventricular fibrillation).

               -  Significant thrombotic or embolic events within 3 months prior to randomization
                  (significant thrombotic or embolic events include but are not limited to stroke
                  or transient ischemic attack).

               -  Any uncontrolled or severe cardiovascular disease.

          -  History of prior malignancy within 3 years prior to randomization (except for
             adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or
             cervix, superficial bladder cancer, or early stage prostate cancer, without evidence
             of recurrence).

          -  Radiographic evidence of interstitial lung disease.