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

Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179686
• Other study ID #: CC-5013-NSCL-001
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2005
• Last updated: December 19, 2006
• Start date: March 2005
• Est. completion date: July 2006

Study information

• Verified date: December 2006
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• CC-5013

Locations

Country	Name	City	State
United States	Birmingham Cancer Center	Birmingham	Alabama
United States	Rush Cancer Institute	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Cancer and Blood Institute	Metairie	Louisiana
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Celgene Corporation	Prologue Research International

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the safety of lenalidomide monotherapy as treatment for subjects with recurrent non-small cell lung cancer.