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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02976740
Other study ID # KYZ2016-006
Secondary ID
Status Recruiting
Phase Phase 2
First received November 25, 2016
Last updated November 28, 2016
Start date November 2016
Est. completion date December 2019

Study information

Verified date November 2016
Source The First Affiliated Hospital of Xiamen University
Contact Deng Chong, MD
Phone 86-05922139531
Email dengchongxm@163.com
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Fujian Province
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.


Description:

Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 70 Years
Eligibility Inclusion Criteria:Inclusion Criteria:

1. Histologically proven non-small-cell lung cancer.

2. Stage IV according to UICC stage system(version 7,2009).

3. Progression after standard second-line chemotherapy.

4. At least Three evaluable lesions among which at least two must be suitable for SBRT.

5. ECOG performance status 0-2.

6. Expected lifespan =3 months.

7. Stable lab values:

Hematological: Absolute neutrophil count (ANC) =1.5×109/L, Platelets =100×109/L, Hemoglobin =9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate [GFR] can also be used in place of creatinine or CrCl) =1.5× the upper limit of normal (ULN) OR =60 mL/min for patient with creatinine levels >1.5× institutional ULN Hepatic: Total bilirubin =1.5×ULN OR Direct bilirubin =ULN for patients with total bilirubin levels >1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =2.5×ULN OR =5×ULN for patients with liver metastases ,globulin=20 g/L, albumin=30 g/L.

8. Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study drug if of childbearing potential.

9. Able to understand and give written informed consent and comply with study procedures.

Exclusion Criteria:

1. Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy, Including diabetes.

2. Any clinical evidence suggests moderately severe chronic obstructive pulmonary disease (COPD) - [With COPD history or related risk factors, FEV1 / FVC < 70%, FEV1 < 80% estimated value, with or without chronic cough, sputum, dyspnea symptoms), active interstitial lung disease - ILD (FEV1 / FVC < 70%, FEV1 < 80% estimated value, carbon monoxide diffusion capacity in lung - DLCO < 40%, and high resolution CT (HRCT) confirmed as the diffuse pulmonary interstitial lesions] and other active pulmonary disease.

3. Previously diagnosed with autoimmune diseases, including but not limited to systemic lupus erythematous, rheumatoid arthritis, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia and autoimmune liver disease, autoimmune thyroiditis.

4. Human immunodeficiency virus (HIV) infection.

5. Women in pregnancy or lactation .

6. Medicine abusers(including alcohol, drugs or other addictive drugs abusers).

7. Patients with mental illness, considered as "can't fully understand the issues of this research".

8. Cancer history within 5 years apart from NSCLC before enrollment.

9. Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue.

10. Cancer treatment within 4 weeks, including but not limited to palliative surgery ,radiotherapy, chemotherapy and target therapy.

11. Tumor related immunotherapy within 1 year, including but not limited to immune cell therapy, tumor vaccine therapy, immune check-point monoclonal antibody related treatment, and cytokines treatment except for GM-CSF.

12. Allergy of rhGM-CSF/Ta1 and its accessories.

13. Contraindications to GM-CSF/Ta1 treatment.

14. Patients with unilateral lung.

Study Design

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


Related Conditions & MeSH terms


Intervention

Radiation:
SBRT
Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion
Drug:
Immunological Agent
Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
Immunological Factors
Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.

Locations

Country Name City State
China First affiliated Hospital of Xiamen University Xiamen Fujian

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

References & Publications (10)

Formenti SC, Demaria S. Systemic effects of local radiotherapy. Lancet Oncol. 2009 Jul;10(7):718-26. doi: 10.1016/S1470-2045(09)70082-8. Review. — View Citation

Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients wi — View Citation

Golden EB, Demaria S, Schiff PB, Chachoua A, Formenti SC. An abscopal response to radiation and ipilimumab in a patient with metastatic non-small cell lung cancer. Cancer Immunol Res. 2013 Dec;1(6):365-72. doi: 10.1158/2326-6066.CIR-13-0115. — View Citation

Kalbasi A, June CH, Haas N, Vapiwala N. Radiation and immunotherapy: a synergistic combination. J Clin Invest. 2013 Jul;123(7):2756-63. doi: 10.1172/JCI69219. — View Citation

Mellman I, Coukos G, Dranoff G. Cancer immunotherapy comes of age. Nature. 2011 Dec 21;480(7378):480-9. doi: 10.1038/nature10673. Review. — View Citation

Postow MA, Callahan MK, Barker CA, Yamada Y, Yuan J, Kitano S, Mu Z, Rasalan T, Adamow M, Ritter E, Sedrak C, Jungbluth AA, Chua R, Yang AS, Roman RA, Rosner S, Benson B, Allison JP, Lesokhin AM, Gnjatic S, Wolchok JD. Immunologic correlates of the abscopal effect in a patient with melanoma. N Engl J Med. 2012 Mar 8;366(10):925-31. doi: 10.1056/NEJMoa1112824. — View Citation

Reits EA, Hodge JW, Herberts CA, Groothuis TA, Chakraborty M, Wansley EK, Camphausen K, Luiten RM, de Ru AH, Neijssen J, Griekspoor A, Mesman E, Verreck FA, Spits H, Schlom J, van Veelen P, Neefjes JJ. Radiation modulates the peptide repertoire, enhances MHC class I expression, and induces successful antitumor immunotherapy. J Exp Med. 2006 May 15;203(5):1259-71. — View Citation

Suzuki Y, Mimura K, Yoshimoto Y, Watanabe M, Ohkubo Y, Izawa S, Murata K, Fujii H, Nakano T, Kono K. Immunogenic tumor cell death induced by chemoradiotherapy in patients with esophageal squamous cell carcinoma. Cancer Res. 2012 Aug 15;72(16):3967-76. doi: 10.1158/0008-5472.CAN-12-0851. — View Citation

Twyman-Saint Victor C, Rech AJ, Maity A, Rengan R, Pauken KE, Stelekati E, Benci JL, Xu B, Dada H, Odorizzi PM, Herati RS, Mansfield KD, Patsch D, Amaravadi RK, Schuchter LM, Ishwaran H, Mick R, Pryma DA, Xu X, Feldman MD, Gangadhar TC, Hahn SM, Wherry EJ, Vonderheide RH, Minn AJ. Radiation and dual checkpoint blockade activate non-redundant immune mechanisms in cancer. Nature. 2015 Apr 16;520(7547):373-7. doi: 10.1038/nature14292. — View Citation

Zeng J, See AP, Phallen J, Jackson CM, Belcaid Z, Ruzevick J, Durham N, Meyer C, Harris TJ, Albesiano E, Pradilla G, Ford E, Wong J, Hammers HJ, Mathios D, Tyler B, Brem H, Tran PT, Pardoll D, Drake CG, Lim M. Anti-PD-1 blockade and stereotactic radiation produce long-term survival in mice with intracranial gliomas. Int J Radiat Oncol Biol Phys. 2013 Jun 1;86(2):343-9. doi: 10.1016/j.ijrobp.2012.12.025. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary abscopal effect rate at the time point of 4 weeks after completion of the combined treatment No
Secondary overall survival 1 year after completion of the combined treatment No
Secondary Incidence of Adverse events 1 year after completion of the combined treatment Yes
Secondary objective response rate 4 weeks after completion of the combined treatment No
Secondary Incidence of immune-related adverse events 1 year after completion of the combined treatment Yes
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