The purpose of this study is to investigate the safety and efficacy of maintenance therapy
with daily low dose lenalidomide in patients with stage IIIB/IV non-small cell lung cancer
(NSCLC) after first line chemotherapy. Investigators expect this treatment approach will
delay disease progression by boosting the patient's anti-tumor immune response. Investigators
hypothesize that 10 mg/day of lenalidomide can be administered safely as maintenance therapy
and improve progression free survival time.
For patients with stage IIIB/IV non-small cell lung cancer, who did not progress after first
line chemotherapy, lenalidomide 10mg/day orally will be administered as maintenance therapy
until disease progression or death.
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed stage IIIB or stage IV
NSCLC with measurable disease at initial presentation prior to chemotherapy. See
Section 8.4.1 for measurable disease parameters.
- Patients must have had a complete response (CR), partial response (PR) or stable
disease (SD) after 4-6 cycles of first-line chemotherapy. Tumor response will be
assessed by RECIST criteria version 1.1.
- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, or radiotherapy before entering this study.
1. Myelosuppressive chemotherapy: At least 21 days elapsed from end of treatment
before registration (42 days if prior nitrosourea).
2. Hematopoietic growth factors: At least 7 days since the completion of therapy
with a growth factor.
3. Other: For agents that have known adverse events occurring beyond 7 days after
administration, this period must be extended beyond the time during which adverse
events are known to occur.
4. XRT: > or = to 2 weeks for local palliative XRT (small port); 3 months must have
elapsed if 50% radiation of pelvis; 6 weeks must have elapsed if other
substantial bone marrow radiation.
- Patients must be > or = 18 years of age.
- ECOG performance status < or = to 1 (Karnofsky > 70%).
- Organ Functions: Patients must have normal organ and marrow function as defined below
within 28 days of registration:
1. Leukocytes > or = 3,000/uL
2. Absolute neutrophil count > or = 1,500/uL
3. Hemoglobin > or = 8 g/dL
4. Platelets > or = 100,000/uL
5. Total bilirubin 1.5X institutional upper limit of normal (ULN)
6. AST (SGOT) and ALT (SGPT) 1.5X institutional ULN
7. Creatinine clearance > or = 60 mL/min/1.73 m2 for patients with creatinine levels
> institutional normal
- All study participants must be willing and agree to be registered into the mandatory
REVLIMID REMS program, and be willing and able to comply with the requirements of
REVLIMID REM. REVLIMID REMS registration does not need to be complete to determine
study eligibility.
- Females of childbearing potential (FCBP)* must have a negative serum or urine
pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days before
registration. Treating investigator must affirm intention to perform another serum or
urine UPT 24 hours before initiating lenalidomide treatment.
*FCBP: A female of childbearing potential (FCBP) is a sexually mature female who: 1)
has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
naturally postmenopausal (amenorrhea following cancer therapy does not rule out
childbearing potential) for at least 24 consecutive months (i.e., has had menses at
any time in the preceding 24 consecutive months).
- All patients must be counseled about pregnancy precautions, risks of fetal exposure
and other risks. The counseling must be done before the initiation of the study and
every 28 days before the study drug is dispensed to the subject. FCBP must either
commit to continued abstinence from heterosexual intercourse or begin TWO acceptable
methods of birth control, one highly effective method and one additional effective
method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP
must also agree to ongoing pregnancy testing. Men must agree to use a latex condom
during sexual contact with a FCBP even if they have had a successful vasectomy. See
Appendix D: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth
Control Methods.
- Able to take aspirin (81 mg) daily as prophylactic anticoagulation (Patients
intolerant to ASA may use warfarin or low molecular weight heparin).
- Able to understand and willing to sign a written informed consent document.
- Life expectancy > or = 12 weeks
Exclusion Criteria
- Concomitant Medications:
1. Patients may not be receiving any other anti-cancer therapy.
2. Patients may not be receiving any other investigational agents.
3. Patients may not be receiving systemic steroids or other immunosuppressive drugs;
however, steroid containing inhaler may be allowed after discussing with the
Principal Investigator. Duration of 5 half-lives must have elapsed before the
study registration if the patient was on systemic steroids or other
immunosuppressive drugs.
- Patients with untreated brain metastasis, or with treated brain metastasis but
requiring steroids.
- Patients with known EGFR mutation or EML-ALK fusion gene and with stage IV disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to lenalidomide or thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while
taking thalidomide or similar drugs.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, myocardial infarction within the last
6 months, unstable angina pectoris, cardiac arrhythmia, autoimmune disease or
psychiatric illness/social situations that would limit compliance with study
requirements.
- Pregnant or breastfeeding women are excluded from this study because lenalidomide has
the potential for teratogenic or abortifacient effects. Because there is an unknown
but potential risk for adverse events in nursing infants secondary to treatment of the
mother with lenalidomide, breastfeeding should be discontinued if the mother is
treated with lenalidomide.
- Known sera-positive for or active viral infection with human immunodeficiency virus
(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are
seropositive because of hepatitis B virus vaccine are eligible.
- Any other clinically significant medical condition and/or organ dysfunction that will
interfere with the administration of the therapy according to this protocol or which,
in the views of investigator, preclude combination chemotherapy.