A Phase II Study of Concurrent Pemetrexed and Radiation for Poor-Risk Stage III Non-Small Cell Lung Cancer: Hoosier Oncology Group LUN08-129

Inclusion Criteria:

- Histological or cytological proof of Non Small Cell Lung Cancer (NSCLC)

- Measurable or non-measurable disease per RECIST as evaluated by imaging within 28
days prior to registration for protocol therapy

- Unresectable Stage IIIA or IIIB disease as evaluated by imaging within 28 days prior
to registration for protocol therapy

- Weight loss of greater than 10% in the preceding six months prior to registration for
protocol therapy.

- Serum albumin < 0.85 x institutional lower limit of normal

- Able and willing to interrupt non-steroidal anti-inflammatory agents for 2 days
before (5 days for long acting agents such as piroxicam), the day of, and 2 days
following administration of pemetrexed

- Lung V20 < 35% within 14 days prior to registration for protocol therapy, as planned
by the radiation oncologist

- Mean lung dose < 20 Gy within 14 days prior to registration for protocol therapy, as
planned by the radiation oncologist

- Written informed consent and HIPAA authorization for release of personal health
information

- Age ≥ 18 years

- Females of childbearing potential and males must be willing to use an effective
method of contraception (hormonal or barrier method of birth control; abstinence)
from the time of consent until at least 90 days following completion of study
treatment.

- Females of childbearing potential must have a negative pregnancy test within 7 days
prior to registration for protocol therapy. Patients are considered not of child
bearing potential if they are surgically sterile (they have undergone a hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.

Exclusion Criteria:

- Patients with malignant pleural effusions are not eligible. The only exception is a
patient with a pleural effusion visible only on CT scan (and not visible on CXR) OR
deemed too small to tap.• No CNS metastases. All patients must undergo a CT scan/MRI
of the brain within 28 days prior to registration for protocol therapy to exclude
brain metastasis.

- No prior chemotherapy, adjuvant therapy or radiotherapy for lung cancer.

- No metastatic disease as determined by PET scan within 28 days prior to registration
for protocol therapy.

- No active clinically serious infections as judged by the treating investigator (> CTC
v3, Grade 2) including known human immunodeficiency virus (HIV) infection or chronic
Hepatitis B or C.

- No other active malignancies.

- No history of collagen vascular disease (CVD).

- No significant history of cardiac disease. Must not have unstable angina (anginal
symptoms at rest).

- No history of psychiatric illness/social situations that would limit compliance with
study requirements.

- Females must not be breastfeeding.