Phase I Open-Label, Dose Escalation Study To Determine The Maximum Tolerated Dose And To Evaluate The Safety Profile Of Lenalidomide (Revlimid®, CC-5013) With Pemetrexed In Subjects With Advanced Non-Small Cell Lung Cancer
1. Subjects must understand and voluntarily sign an informed consent document.
2. Age >or= 18 years at the time of signing informed consent form.
3. Subjects must be able to adhere to the study visit schedule and other protocol
4. Histological or cytologic documentation of advanced NSCLC.
5. Radiographic or clinical evidence of measurable advanced NSCLC. Subjects must have
measurable disease at least 2 cm in diameter.
6. Subjects must have been treated and progressed following chemotherapy.
7. ECOG performance status of 0 or 1 (Appendix I: ECOG Performance Status Scale).
8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy
test within 7 days of starting study drug. In addition, sexually active WCBP must
agree to use adequate contraceptive methods (oral, injectable, or implantable
hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive
with spermicide; or vasectomized partner) while on study drug.
1. Any of the following laboratory abnormalities:
1. Absolute neutrophil count (ANC) <1,500 cells/mm3 (1.5 x 109/L)
2. Platelet count <100,000 cells/mm3 (100 x 109/L)
3. Serum creatinine >1.5 mg/dL (133 mmol/L)
4. Serum SGOT/AST or SGPT/ALT >3.0 x upper limit of normal (ULN)
5. Serum total bilirubin >or = 1.5 mg/dL (26 mmol/L)
2. Any serious medical condition or psychiatric illness that places the subject at an
unacceptable risk for study participation or would prevent the subject from signing
the informed consent.
3. Prior history of malignancy (except basal cell or squamous cell carcinoma or
carcinoma in situ of the breast) unless the subject has been free of disease for > 1
4. Known brain or leptomeningeal disease (CT scan or MRI of the brain required only in
case of clinical suspicion of central nervous system involvement).
5. More than one prior chemotherapy for advanced NSCLC.
6. Concurrent use of any other anti-cancer agents.
7. Any prior use of lenalidomide.
8. Pregnant or lactating females.
9. Prior > or = to grade 3 rash or any desquamating (blistering) rash while taking
10. Prior > or = to grade 3 allergic reaction/hypersensitivity to thalidomide.
11. Use of any standard/experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.
12. Known Hepatitis C.