A Study of XL184 (Cabozantinib) With or Without Erlotinib in Adults With Non-Small Cell Lung Cancer

Inclusion Criteria:

   - Histologically confirmed NSCLC and Stage 3b or 4 NSCLC (Phase 1 only), Stage 3b or 4
   NSCLC (Phase 2 only)

   - Documented progressive disease following a prior RECIST response to monotherapy with
   erlotinib OR documented progressive disease following stable disease of at least 6
   months on monotherapy with erlotinib (Phase 2 only)

   - Must have tolerated erlotinib at the maximal dose that will be administered in Phase 2
   only (or at a higher dose) for a minimum of 6 weeks

   - Measurable disease per RECIST (Phase 2 only)

   - At least 18 years old

   - ECOG performance status of 0 or 1

   - Adequate organ and marrow function

   - Sexually active subjects must agree to use medically accepted methods of contraception
   during the course of the study and for 3 months following discontinuation of study
   treatment (excluding women who are not of child bearing potential and men who have
   been sterilized).

   - Female subjects of childbearing potential must have a negative pregnancy test at
   enrollment

   - No other diagnosis of malignancy (unless non-melanoma skin cancer, carcinoma in situ
   of the cervix or malignancy diagnosed ≥ 2 years previously, and currently with no
   evidence of disease).

   - Capable of understanding and complying with the protocol, and written informed consent

Exclusion Criteria:

   - Received anti-cancer treatment within 4 weeks, except erlotinib, prior to first dose
   (Phase 1 only)

   - In Phase 2 only: the subject has received:

      - Small molecule inhibitors of VEGFR2/KDR OR

      - An investigational anti-cancer agent within 4 weeks of the first dose of study
      drug OR

      - An investigational agent that targets EGF or EGFR at any time OR

      - An approved agent that targets EGF or EGFR (with the exception of erlotinib and
      gefitinib) at any time unless approved by Exelixis OR

      - Anti-cancer therapy within 4 weeks (with the exception of gefitinib and
      erlotinib) of the first dose of study drug OR

      - Prior therapy with a c-Met inhibitor

   - Not recovered to NCI CTCAE v.3 Grade ≤1 from clinically significant adverse events due
   to antineoplastic agents, investigational drugs, or other medications administered
   prior to study enrollment

   - Symptomatic or uncontrolled brain metastases requiring current treatment, including
   steroids and anticonvulsants

   - History of significant hematemesis or recent history of hemoptysis

   - Presence of cavitation, central lesion, or lesion abutting a major blood vessel

   - Intercurrent illness such as hypertension or cardiac arrhythmias or recent history of
   significant disease such as congestive heart failure

   - Pregnant or breastfeeding

   - Active bacterial or viral infection requiring systemic treatment

   - Allergy or hypersensitivity to components of either the XL184 or erlotinib
   formulations

   - Incapable of understanding and complying with the protocol or unable to provide
   informed consent

   - History of idiopathic pulmonary fibrosis or interstitial lung disease