Trial Information

A Phase II Trial of the HIV Protease Inhibitor Nelfinavir and Concurrent Radiation and Chemotherapy in Patients With Stage III Non Small Cell Lung Cancer

This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination
with radiotherapy and chemotherapy in patients with locally advanced non-small cell lung
cancer (NSCLC) who are considered candidates for pre-operative treatment. This study is to
be conducted according to US and international standards of Good Clinical Practice (FDA
Title 21 part 312 and International Conference on Harmonization guidelines), applicable
government regulations and Institutional research policies and procedures. The endpoints are
to determine safety of NFV with chemoradiation, gather preliminary data for response, and
tissue specimens for correlative molecular studies. Unacceptable toxicity is unlikely as
prior studies have determined dosing 1250 mg twice a day is relatively safe for HIV patients
receiving radiation therapy. NFV will start one week prior to chemo-radiotherapy and
continue for the duration of chemoradiation (approximately 6 1/2 weeks). Standard
radiotherapy (minimum total dose 5040 cGy) and combined (cisplatin/etoposide) chemotherapy
based on SWOG 8805 will be delivered in combination with NFV. The thoracic surgery attending
physician will determine the feasibility of resection. If the patient has resectable
disease, the attending thoracic surgeon will perform the thoracotomy and anatomical
resection. If the patient has unresectable disease, subject will be followed for 30 days
post NFV administration. After the initial 30 days post-NFV, subjects will be followed for
long-term outcomes (disease response and overall survival). Adjuvant therapy may be
continued off-study at the discretion of managing oncology personnel. Tumors obtained at the
time of surgical resection will be assessed for pathological response. Tumor tissue taken
pre-treatment will be assessed for markers that may predict response such as Akt, VEGF, and
EGFR.