Protocol EC-FV-03: A Phase II Study of EC145 in Patients With Progressive Adenocarcinoma of the Lung

Inclusion Criteria:

- Advanced, progressive, adenocarcinoma of the lung.

- Previously received at least 2 cytotoxic containing chemotherapeutic regimens (can
include an EGFR inhibitor). There is no upper limit to the number of prior
chemotherapeutic regimens.

- ECOG performance status of 0-2.

- At least 4 weeks from prior therapy and recovered from associated acute toxicities.

- Radiographic evidence of measurable disease and EC20 "positive" tumor.

- Adequate bone marrow reserve, hepatic, and renal function.

- Negative serum pregnancy test for women of childbearing potential and willingness to
practice contraceptive methods.

Exclusion Criteria:

- Serious comorbidities (as determined by the Principal Investigator).

- History of carcinomatous peritonitis.

- History of severe bowel obstruction (as determined by the Principal Investigator).

- Women who are pregnant or lactating.

- Prior radiation therapy to assessable disease, unless disease progression is
confirmed at that site.

- Patients requiring palliative radiotherapy at time of study entry.

Note: Patients with CNS metastasis are eligible if a) they have been treated for the CNS
metastasis and have been clinically stable (with regard to their CNS disease) for >4 weeks
and b) they do not require steroids or antiseizure medications (i.e., for seizure
control), or if the CNS metastasis has been untreated to date, it is not associated with a
midline shift or significant edema and there is no clinically-evident requirement for
steroids or antiseizure medication. In either situation, patients must be off steroids
and/or antiseizure medications for at least 14 days.