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CompletedNCT00179686Updated Dec 20, 2006

A Study to Evaluate the Single-Agent Lenalidomide in Subjects With Recurrent Non-Small-Cell Lung Cancer

A Phase 2 interventional study of CC-5013 in Non-Small Cell Lung Cancer, sponsored by Celgene Corporation. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-12-20.

Sponsored by Celgene Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Subjects who qualify will receive single agent lenalidomide once daily on days 1-21 of 28 day cycles. Subjects will continue until disease progression is documented.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • celgene
  • cc-5013
  • NSCLC
  • CC5013
  • Revlimid
  • Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Celgene Corporation is the lead sponsor of 50 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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 thalidomide.
  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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants

Interventions

  • DrugCC-5013
06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.

07

Study locations

6 sites
  • Birmingham Cancer Center
    Birmingham, Alabama 35294, United States
  • Rush Cancer Institute
    Chicago, Illinois 60612, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Cancer and Blood Institute
    Metairie, Louisiana 70006, United States
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00179686
Lead sponsor
Celgene Corporation
Collaborators
Prologue Research International
First posted
Sep 16, 2005
Start date
Mar 2005
Completion
Jul 2006
Last update
Dec 20, 2006
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2006. You cannot join it, but the record below documents what was studied.

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