Carcinoma, Non-Small-Cell LungPhase 1NCT02018523
Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer
A Phase 1 study testing Lenalidomide in people with Carcinoma, Non-Small-Cell Lung, run by Jun Zhang at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Myelosuppressive chemotherapy: At least 21 days elapsed from end of treatment before registration (42 days if prior nitrosourea).
- Hematopoietic growth factors: At least 7 days since the completion of therapy with a growth factor.
- 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.
Show all 24Show fewer
- 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:
- Leukocytes > or = 3,000/uL
- Absolute neutrophil count > or = 1,500/uL
- Hemoglobin > or = 8 g/dL
- Platelets > or = 100,000/uL
- Total bilirubin 1.5X institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) 1.5X institutional ULN
- 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
Who cannot join
- Concomitant Medications:
- Patients may not be receiving any other anti-cancer therapy.
- Patients may not be receiving any other investigational agents.
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer After First-line Chemotherapy
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.
Read the detailed description
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.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Lenalidomide
- Keywords
- Carcinoma, Non-Small-Cell Lung, Stage 3B/4, Maintenance Therapy, Lenalidomide
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
lenalidomide 10mg/day orally until disease progression
| Study group | Role | What they receive |
|---|---|---|
| Lenalidomide | Experimental | Oral lenalidomide 10 mg daily until disease progression Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival is defined as the duration of time from the date starting lenalidomide to the date of documented radiographic progression or death.
Measured: up to 6 months from the date of registration
Secondary outcomes (7)
Number of participants with adverse events
Measured: From date of registration to end of study, up to 3 years
Change in circulating immune cells
Measured: Change from baseline at 1 week
Change in circulating immune cells
Measured: Change from baseline at 5 weeks
Change in circulating immune cells
Measured: Change from baseline at 9 weeks
Change in circulating immune cells
Measured: Change from baseline at 13, 17, 21 and 25 weeks
Change in circulating immune cells
Measured: Change from baseline to 6 months, 9 months and 1 year
Change in circulating immune cells
Measured: Change from baseline to 1.5, 2, 2.5 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Study did not enroll enough subjects to make a statistically sound conclusion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jun Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation, Baylor College of Medicine
- Responsible party
- Sponsor-investigator, Jun Zhang, Baylor College of Medicine
- Investigators
- Jun Zhang, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018523
- Sponsor's protocol ID
- H-32774
- Status last verified
- Jan 2018
- First submitted
- 17 Dec 2013
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
PubMed 11784875Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
PubMed 20493771Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
PubMed 23835707Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
PubMed 19767093Sakaguchi S, Yamaguchi T, Nomura T, Ono M. Regulatory T cells and immune tolerance. Cell. 2008 May 30;133(5):775-87. doi: 10.1016/j.cell.2008.05.009.
PubMed 18510923Al-Shibli KI, Donnem T, Al-Saad S, Persson M, Bremnes RM, Busund LT. Prognostic effect of epithelial and stromal lymphocyte infiltration in non-small cell lung cancer. Clin Cancer Res. 2008 Aug 15;14(16):5220-7. doi: 10.1158/1078-0432.CCR-08-0133.
PubMed 18698040Kawai O, Ishii G, Kubota K, Murata Y, Naito Y, Mizuno T, Aokage K, Saijo N, Nishiwaki Y, Gemma A, Kudoh S, Ochiai A. Predominant infiltration of macrophages and CD8(+) T Cells in cancer nests is a significant predictor of survival in stage IV nonsmall cell lung cancer. Cancer. 2008 Sep 15;113(6):1387-95. doi: 10.1002/cncr.23712.
PubMed 18671239Petersen RP, Campa MJ, Sperlazza J, Conlon D, Joshi MB, Harpole DH Jr, Patz EF Jr. Tumor infiltrating Foxp3+ regulatory T-cells are associated with recurrence in pathologic stage I NSCLC patients. Cancer. 2006 Dec 15;107(12):2866-72. doi: 10.1002/cncr.22282.
PubMed 17099880Shimizu K, Nakata M, Hirami Y, Yukawa T, Maeda A, Tanemoto K. Tumor-infiltrating Foxp3+ regulatory T cells are correlated with cyclooxygenase-2 expression and are associated with recurrence in resected non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):585-90. doi: 10.1097/JTO.0b013e3181d60fd7.
PubMed 20234320Erfani N, Mehrabadi SM, Ghayumi MA, Haghshenas MR, Mojtahedi Z, Ghaderi A, Amani D. Increase of regulatory T cells in metastatic stage and CTLA-4 over expression in lymphocytes of patients with non-small cell lung cancer (NSCLC). Lung Cancer. 2012 Aug;77(2):306-11. doi: 10.1016/j.lungcan.2012.04.011. Epub 2012 May 17.
PubMed 22608141Karagoz B, Bilgi O, Gumus M, Erikci AA, Sayan O, Turken O, Kandemir EG, Ozturk A, Yaylaci M. CD8+CD28- cells and CD4+CD25+ regulatory T cells in the peripheral blood of advanced stage lung cancer patients. Med Oncol. 2010 Mar;27(1):29-33. doi: 10.1007/s12032-008-9165-9. Epub 2009 Jan 16.
PubMed 19148592Elias D, Lasser PH, Desruennes E, Mankarios H, Jiang Y. Surgical approach to segment I for malignant tumors of the liver. Surg Gynecol Obstet. 1992 Jul;175(1):17-24.
PubMed 1621195Okita R, Saeki T, Takashima S, Yamaguchi Y, Toge T. CD4+CD25+ regulatory T cells in the peripheral blood of patients with breast cancer and non-small cell lung cancer. Oncol Rep. 2005 Nov;14(5):1269-73.
PubMed 16211295Woo EY, Yeh H, Chu CS, Schlienger K, Carroll RG, Riley JL, Kaiser LR, June CH. Cutting edge: Regulatory T cells from lung cancer patients directly inhibit autologous T cell proliferation. J Immunol. 2002 May 1;168(9):4272-6. doi: 10.4049/jimmunol.168.9.4272.
PubMed 11970966LeBlanc R, Hideshima T, Catley LP, Shringarpure R, Burger R, Mitsiades N, Mitsiades C, Cheema P, Chauhan D, Richardson PG, Anderson KC, Munshi NC. Immunomodulatory drug costimulates T cells via the B7-CD28 pathway. Blood. 2004 Mar 1;103(5):1787-90. doi: 10.1182/blood-2003-02-0361. Epub 2003 Sep 25.
PubMed 14512311
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Lenalidomide Maintenance Therapy in Stage IIIB/IV Non-small Cell Lung Cancer After First-line Chemotherapy
- ClinicalTrials.gov ID
- NCT02018523
- Acronym / sponsor ID
- H-32774
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung, Stage 3B/4, Maintenance Therapy, Lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study did not enroll enough subjects to make a statistically sound conclusion.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jun ZhangUniversity, hospital or other
- Collaborators
- Celgene Corporation, Baylor College of Medicine
- Study start
- Jun 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: LenalidomideOral lenalidomide 10 mg daily until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- Patients must be > or = 18 years of age.
- ECOG performance status < or = to 1 (Karnofsky > 70%).
Key exclusion criteria (12 listed)
- Concomitant Medications:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: Revlimidlenalidomide 10mg/day orally until disease progression | Drug | Lenalidomide |
Primary outcome
Progression free survival
Time frame: up to 6 months from the date of registration
Progression free survival is defined as the duration of time from the date starting lenalidomide to the date of documented radiographic progression or death.
7 secondary outcomes
Number of participants with adverse events
Time frame: From date of registration to end of study, up to 3 years
Change in circulating immune cells
Time frame: Change from baseline at 1 week
Change in circulating immune cells
Time frame: Change from baseline at 5 weeks
Change in circulating immune cells
Time frame: Change from baseline at 9 weeks
Change in circulating immune cells
Time frame: Change from baseline at 13, 17, 21 and 25 weeks
Change in circulating immune cells
Time frame: Change from baseline to 6 months, 9 months and 1 year
Change in circulating immune cells
Time frame: Change from baseline to 1.5, 2, 2.5 and 3 years
Results and safety
The study was stopped early (reason given: Study did not enroll enough subjects to make a statistically sound conclusion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Background: PubMed 11784875Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
- Background: PubMed 20493771Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.
- Background: PubMed 23835707Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
- Background: PubMed 19767093Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
- Background: PubMed 18510923Sakaguchi S, Yamaguchi T, Nomura T, Ono M. Regulatory T cells and immune tolerance. Cell. 2008 May 30;133(5):775-87. doi: 10.1016/j.cell.2008.05.009.
- Background: PubMed 18698040Al-Shibli KI, Donnem T, Al-Saad S, Persson M, Bremnes RM, Busund LT. Prognostic effect of epithelial and stromal lymphocyte infiltration in non-small cell lung cancer. Clin Cancer Res. 2008 Aug 15;14(16):5220-7. doi: 10.1158/1078-0432.CCR-08-0133.
- Background: PubMed 18671239Kawai O, Ishii G, Kubota K, Murata Y, Naito Y, Mizuno T, Aokage K, Saijo N, Nishiwaki Y, Gemma A, Kudoh S, Ochiai A. Predominant infiltration of macrophages and CD8(+) T Cells in cancer nests is a significant predictor of survival in stage IV nonsmall cell lung cancer. Cancer. 2008 Sep 15;113(6):1387-95. doi: 10.1002/cncr.23712.
- Background: PubMed 17099880Petersen RP, Campa MJ, Sperlazza J, Conlon D, Joshi MB, Harpole DH Jr, Patz EF Jr. Tumor infiltrating Foxp3+ regulatory T-cells are associated with recurrence in pathologic stage I NSCLC patients. Cancer. 2006 Dec 15;107(12):2866-72. doi: 10.1002/cncr.22282.
- Background: PubMed 20234320Shimizu K, Nakata M, Hirami Y, Yukawa T, Maeda A, Tanemoto K. Tumor-infiltrating Foxp3+ regulatory T cells are correlated with cyclooxygenase-2 expression and are associated with recurrence in resected non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):585-90. doi: 10.1097/JTO.0b013e3181d60fd7.
- Background: PubMed 22608141Erfani N, Mehrabadi SM, Ghayumi MA, Haghshenas MR, Mojtahedi Z, Ghaderi A, Amani D. Increase of regulatory T cells in metastatic stage and CTLA-4 over expression in lymphocytes of patients with non-small cell lung cancer (NSCLC). Lung Cancer. 2012 Aug;77(2):306-11. doi: 10.1016/j.lungcan.2012.04.011. Epub 2012 May 17.
- Background: PubMed 19148592Karagoz B, Bilgi O, Gumus M, Erikci AA, Sayan O, Turken O, Kandemir EG, Ozturk A, Yaylaci M. CD8+CD28- cells and CD4+CD25+ regulatory T cells in the peripheral blood of advanced stage lung cancer patients. Med Oncol. 2010 Mar;27(1):29-33. doi: 10.1007/s12032-008-9165-9. Epub 2009 Jan 16.
- Background: PubMed 1621195Elias D, Lasser PH, Desruennes E, Mankarios H, Jiang Y. Surgical approach to segment I for malignant tumors of the liver. Surg Gynecol Obstet. 1992 Jul;175(1):17-24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Zhang, M.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Carcinoma, Non-Small-Cell Lung, run by Jun Zhang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study did not enroll enough subjects to make a statistically sound conclusion.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: up to 6 months from the date of registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02018523, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.