A Study of Nab-Paclitaxel and Carboplatin Plus Necitumumab (LY3012211) in Participants With Stage IV Squamous NSCLC
Condition: Carcinoma, Non-Small Cell Lung Cancer (NSCLC)
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Necitumumab; Nab-Paclitaxel; Carboplatin
Intervention description: Administered IV; Administered IV; Administered IV
Intervention MeSH terms: Paclitaxel; Carboplatin; Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if nab-paclitaxel and carboplatin chemotherapy plus
      necitumumab is effective and safe in participants with stage IV squamous non-small cell lung
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histologically or cytologically confirmed squamous NSCLC.

          -  Have stage IV disease at the time of study entry (American Joint Committee on Cancer
             [AJCC] Staging Manual, 7th edition).

          -  Have measurable disease at the time of study enrollment as defined by Response
             Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1).

          -  Have tumor tissue available for biomarker analysis.

          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.

          -  Have adequate organ functions.

        Exclusion Criteria:

          -  Are currently enrolled in another clinical trial.

          -  Have received prior anticancer therapy with monoclonal antibodies, signal transduction
             inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR),
             vascular endothelial growth factor (VEGF), or VEGF receptor.

          -  Have received previous chemotherapy for advanced NSCLC. Participants who have received
             adjuvant or neoadjuvant chemotherapy are eligible if the last administration of the
             prior regimens occurred at least 1 year prior to study entry.

          -  Have undergone major surgery or received any investigational therapy in the 4 weeks
             prior to study entry.

          -  Have undergone systemic radiotherapy within 4 weeks prior to study entry, or focal
             radiotherapy within 2 weeks prior to study entry.

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
             required).

          -  Have a history of arterial or venous embolism within 6 months prior to study entry.

          -  Have clinical evidence of concomitant infectious conditions.

          -  Have a known allergy / history of hypersensitivity reaction to any of the treatment
             components, including any ingredient used in the formulation of necitumumab, or any
             other contraindication to one of the administered treatments.

          -  Are pregnant or breastfeeding.

          -  Have a known history of drug abuse.

          -  Have a concurrent active malignancy. Participants with a history of malignancy are
             eligible provided the participant has been disease-free for ≥3 years, with the
             following exception: Participants with adequately treated basal or squamous cell
             carcinoma of the skin, preinvasive carcinoma of the cervix, or any cancer that in the
             judgment of the investigator and Lilly clinical research physician/designee may not
             affect the interpretation of results (for example, prostate, bladder) are eligible.

          -  Have discontinued investigational product or non approved use of a drug or device from
             a clinical trial within 30 days before the first day of study treatment.