A Safety and Feasibility Study of AGS-003-LNG for the Treatment of Stage 3 Non Small Cell Lung Cancer

Feasibility and Safety study of autologous dendritic cell immunotherapy (AGS-003-LNG) in
patients with resectable non-small cell lung cancer. Non-small cell lung cancer tumor will
be resected from the patient. RNA from the tumor will be amplified and subsequently
electroporated into matured, autologous dendritic cells. The dendritic cells with tumor RNA
will be dosed back to the patient. Study will investigate feasibility and safety.

Inclusion Criteria:

1. Age ≥ 19 years.

2. Newly diagnosed non-small cell lung cancer indicated for routine lobectomy,
mediastinoscopy, wedge resection, thoracotomy or Video-assisted thoracoscopic surgery
(VATS) procedures with tumor collection.

3. Stage III (T1-3, N1-2, M0) of any histology.

4. Scheduled for routine lobectomy, mediastinoscopy, wedge resection, thoracotomy or
VATS procedures.

5. Signed and dated informed consent document for study participation.

After tumor collection, potential subjects must meet all the following criteria to be
enrolled in study treatment:

1. Successful RNA isolation and amplification from tumor sample (as determined by
Argos).

2. Karnofsky performance status (KPS) score of 80-100.

3. Life expectancy of six months or greater.

4. NSCLC of any histology.

5. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to
Grade ≤ 1 according to National Cancer Institute (NCI) Common Terminology Criteria
for Adverse Events (CTCAE) Version 4.0.

6. Negative serum pregnancy test for female subjects with reproductive potential, and
agreement of all male and female subjects of reproductive potential to use a reliable
form of contraception during the study and for 12 weeks after the last dose of study
drug.

7. Able to abstain from taking prohibited drugs, either prescription or
non-prescription, during the treatment phase of the study.

8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests, and other study procedures.

9. Signed and dated informed consent document indicating that the subject (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment.

Exclusion Criteria:

1. Active autoimmune disease or condition requiring chronic immunosuppressive therapy

2. Any clinically significant condition that prohibits the initiation of standard of
care.

3. Malignancies within the prior three years, except for:

- treated in situ carcinomas or non-melanoma skin cancer.

- adequately treated early stage breast cancer.

- superficial bladder cancer.

- non-metastatic prostate cancer with a normal prostate-specific antigen (PSA)
level.

4. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or evidence of brain or leptomeningeal disease.

5. Clinically significant disorders or conditions including

- cardiovascular system.

- renal system.

- hepatic organ system.

- coagulation disorders.

6. Clinically significant infections, including human immunodeficiency virus (HIV),
syphilis, and active hepatitis B or C.

7. Pregnant or breastfeeding.

8. Any serious medical condition or illness considered by the investigator to constitute
an unwarranted high risk for investigational treatment.