A Phase I Dose Escalation Study of the HIV Protease Inhibitor, Nelfinavir, Given Concomitantly With Radical Radiotherapy (RT) for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Inclusion Criteria:
- Histologically confirmed NSCLC except bronchoalveolar cancer
- Patients deemed suitable for radical RT according to local policy
- TNM stage T1-2, N0-1, M0 plus patients with local recurrence
- Adequate lung function as defined by protocol
- Age ≥ 18 years
- ECOG performance status 0-2
- Written informed consent
- Patient able and willing to comply with all protocol requirements
Exclusion Criteria:
- History of other active invasive malignancy (excluding non-melanoma skin cancer and
in situ carcinoma of the cervix), where the extent of disease or treatment for that
condition may interfere with the study endpoints
- Previous RT to the chest
- Chemotherapy, immunotherapies or investigational medicinal products within 4 weeks of
the start of nelfinavir treatment. Ie any neoadjuvant treatment must be completed 4
weeks prior.
- Liver impairment (serum bilirubin ≥ 2 times upper limit of normal, serum AST ≥ 2
times the upper limit of normal)
- Pregnant or breast-feeding women or women of childbearing potential unless effective
methods of contraception are used. Contraceptives that contain norethisterone or
ethinylestradiol must be replaced by other contraceptive measures
- Concurrent use of contraindicated drugs that cannot be substituted or discontinued 2
weeks or more prior to the start of trial treatment
- Known hypersensitivity to nelfinavir or any of its excipients
- Other psychological, social or medical condition, physical examination finding or a
laboratory abnormality that the Investigator considers would make the patient a poor
trial candidate or could interfere with protocol compliance or the interpretation of
trial results