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A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Safety and Efficacy of Single-Agent Lenalidomide (Revlimid, CC-5013) in Subjects With Recurrent Non-Small Cell Lung Cancer

Inclusion Criteria:

1. Understand and voluntarily sign an informed consent form.

2. Age >or = to 18 years at the time of signing the informed consent form

3. Able to adhere to the study visit schedule and other protocol requirements

4. Must have a histologically confirmed diagnosis of non small cell lung cancer that has
recurred following at least two prior regimens. Those regimens must have contained
both a platinum compound and a taxane either sequentially or in combination

5. Subjects must have measurable disease on cross sectional imaging that is at least 2
cm in the longest diameter.

6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see
Appendix II).

7. 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.

WCBP must agree to have pregnancy tests every 4 weeks while on study drug (every 14 days
for women with irregular cycles) and 4 weeks after the last dose of study drug.

Exclusion Criteria:

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/mm3 (100 x 109/L)

3. Serum creatinine >2.5 mg/dL (221 mmol/L)

4. Serum SGOT/AST or SGPT/ALT >5.0 x upper limit of normal (ULN)

5. Serum total bilirubin >2.0 mg/dL (34 mmol/L)

2. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.

3. Prior history of malignancies other than non-small cell lung cancer (except for basal
cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or
breast) unless the subject has been free of the disease for > or = to 1 year.

4. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.

5. Pregnant or lactating females.

6. Prior > or = grade 3 allergic reaction/hypersensitivity to thalidomide.

7. Prior > or = grade 3 rash or any desquamating (blistering) rash while taking

8. Prior use of lenalidomide.

9. Use of any standard/experimental anti-cancer drug therapy within 28 days of the
initiation of study drug therapy.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the activity of lenalidiomide in recurrent non-small cell lung cancer. Activity will be assessed by measuring the response rate, tumor control rate, and time to tumor progression.


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

July 2006

Related Keywords:

  • Non-Small Cell Lung Cancer
  • celgene
  • cc-5013
  • CC5013
  • Revlimid
  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



MD Anderson Cancer CenterHouston, Texas  77030-4096
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Rush Cancer InstituteChicago, Illinois  60612
Cancer and Blood InstituteMetairie, Louisiana  70006
University of ChicagoChicago, Illinois  60637
Birmingham Cancer CenterBirmingham, Alabama  35294