A Study of LY3023414 and Necitumumab in Squamous Lung Cancer
Condition: Non-small Cell Lung Cancer Metastatic
MeSH terms: Lung Neoplasms
Intervention: LY3023414; Necitumumab
Intervention description: Administered orally; Administered IV
Intervention MeSH terms: Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety and activity of the study drug known
      as LY3023414 in combination with necitumumab in participants with metastatic squamous
      non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed squamous advanced NSCLC (Stage IV).

          -  Participants must have progressed on one prior line of platinum-based chemotherapy in
             the advanced or metastatic setting.

          -  Measurable disease as measured by response evaluation criteria in solid tumors
             (RECIST) criteria v 1.1.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

          -  Able to swallow the study drugs whole.

          -  Adequate organ function.

          -  Women of childbearing potential must have a negative serum or urine pregnancy test
             performed ≤ 7 days prior to start of treatment. Women of childbearing potential or men
             with partners of childbearing potential must use effective birth control measures
             during treatment and during the 3 months following completion of study treatment.

        Exclusion Criteria:

          -  Participants who have received > 1 prior line of chemotherapy in the advanced or
             metastatic setting. (Immunotherapy will not be considered a line of chemotherapy.)

          -  Prior treatment with a PI3K/mTOR inhibitor, epidermal growth factor receptor (EGFR)
             inhibitor, and/or necitumumab.

          -  History of brain metastases unless irradiated ≥ 2 weeks prior to first study treatment
             and stable without requirement of corticosteroids.

          -  Have serious pre-existing medical conditions.

          -  Have insulin-dependent diabetes mellitus. Participants with a type 2 diabetes mellitus
             are eligible if adequate control of blood glucose level is obtained by oral
             anti-diabetics.

          -  Women who are pregnant or breast-feeding.

          -  Clinically significant electrolyte imbalance ≥ Grade 2.

          -  Currently receiving treatment with therapeutic doses of warfarin sodium. Low molecular
             weight heparin and oral Xa inhibitors are allowed.

          -  Have initiated treatment with bisphosphonates or approved receptor activator of
             nuclear factor kappa-B ligand (RANK-L) targeted agents (e.g. denosumab) ≤ 28 days
             prior to Day 1 of Cycle 1.

          -  Concurrent serious infection requiring parenteral antibiotic therapy.

          -  Have a second primary malignancy that in the judgment of the investigator and Medical
             Monitor may affect the interpretation of results.

          -  Have an active, known fungal, bacterial, and/or known viral infection.

          -  History of arterial or venous embolism within 3 months prior to study enrollment. If
             the embolism occurred >3 and <6 months, the participant is eligible provided
             appropriate treatment according to institutional standard of care is ensured.