Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

NCT03659578 | Completed Phase 2

• 1 other identifier: GASTO-1043
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer; Split-course Chemoradiotherapy; Thymosin a1

Outcome Measures

Primary Outcomes (1)

• Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)

  Radiation-induced pneumonitis except other reasons induced pneumonia

  1-year

Secondary Outcomes (3)

• Total lymphocyte count

  From the beginning of CCRT until 6 months after the completion of CCRT.

• C-reaction protein

  From the beginning of CCRT until 6 months after the completion of CCRT.

• grade of pulmonary fibrosis (CTCAE 5.0 version)

  1-year

Other Outcomes (1)

• Alpha diversity of gut microbiota as the exploratory outcome

  From baseline to the end of CCRT, an average of 2 months

Study Arms (1)

Thymosin α1

EXPERIMENTAL

Patients are treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Drug: Concurrent chemotherapy; Radiation: split-course radiotherapy; Drug: thymosin alpha 1

Interventions

Concurrent chemotherapy DRUG

Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.

Thymosin α1

split-course radiotherapy RADIATION

Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost

Thymosin α1

thymosin alpha 1 DRUG

subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.

Thymosin α1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic confirmation of NSCLC.
• Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI.
• Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Previously treated with chemotherapy or treatment-naive
• No previous chest radiotherapy, immunotherapy or biotherapy
• Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
• Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
• Bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
• FEV1 \>0.8 L
• CB6 within normal limits
• patients and their family signed the informed consents

You may not qualify if:

• Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ
• Contraindication for chemotherapy
• Malignant pleural or pericardial effusion.
• Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• Women who has the probability of pregnancy without contraception
• Tendency of hemorrhage
• In other clinical trials within 30 days
• Addicted in drugs or alcohol, AIDS patients
• Uncontrollable seizure or psychotic patients without self-control ability
• Severe allergy or idiosyncrasy
• Not suitable for this study judged by researchers

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (24)

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

  PMID: 28055103 BACKGROUND

• Mery B, Guy JB, Swalduz A, Vallard A, Guibert C, Almokhles H, Ben Mrad M, Rivoirard R, Falk AT, Fournel P, Magne N. The evolving locally-advanced non-small cell lung cancer landscape: Building on past evidence and experience. Crit Rev Oncol Hematol. 2015 Nov;96(2):319-27. doi: 10.1016/j.critrevonc.2015.05.020. Epub 2015 Jun 7.

  PMID: 26095618 BACKGROUND

• Furuse K, Fukuoka M, Kawahara M, Nishikawa H, Takada Y, Kudoh S, Katagami N, Ariyoshi Y. Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer. J Clin Oncol. 1999 Sep;17(9):2692-9. doi: 10.1200/JCO.1999.17.9.2692.

  PMID: 10561343 BACKGROUND

• Wang T, Nelson RA, Bogardus A, Grannis FW Jr. Five-year lung cancer survival: which advanced stage nonsmall cell lung cancer patients attain long-term survival? Cancer. 2010 Mar 15;116(6):1518-25. doi: 10.1002/cncr.24871.

  PMID: 20108308 BACKGROUND

• Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, Movsas B, Wasserman T, Rosenthal SA, Gore E, Machtay M, Sause W, Cox JD. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst. 2011 Oct 5;103(19):1452-60. doi: 10.1093/jnci/djr325. Epub 2011 Sep 8.

  PMID: 21903745 BACKGROUND

• Fournel P, Robinet G, Thomas P, Souquet PJ, Lena H, Vergnenegre A, Delhoume JY, Le Treut J, Silvani JA, Dansin E, Bozonnat MC, Daures JP, Mornex F, Perol M; Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie. Randomized phase III trial of sequential chemoradiotherapy compared with concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study. J Clin Oncol. 2005 Sep 1;23(25):5910-7. doi: 10.1200/JCO.2005.03.070. Epub 2005 Aug 8.

  PMID: 16087956 BACKGROUND

• Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.

  PMID: 20351327 BACKGROUND

• Marks LB, Bentzen SM, Deasy JO, Kong FM, Bradley JD, Vogelius IS, El Naqa I, Hubbs JL, Lebesque JV, Timmerman RD, Martel MK, Jackson A. Radiation dose-volume effects in the lung. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3 Suppl):S70-6. doi: 10.1016/j.ijrobp.2009.06.091.

  PMID: 20171521 BACKGROUND

• Gielda BT, Marsh JC, Zusag TW, Faber LP, Liptay M, Basu S, Warren WH, Fidler MJ, Batus M, Abrams RA, Bonomi P. Split-course chemoradiotherapy for locally advanced non-small cell lung cancer: a single-institution experience of 144 patients. J Thorac Oncol. 2011 Jun;6(6):1079-86. doi: 10.1097/JTO.0b013e3182199a7c.

  PMID: 21532501 BACKGROUND

• Spoelstra FO, Pantarotto JR, van Sornsen de Koste JR, Slotman BJ, Senan S. Role of adaptive radiotherapy during concomitant chemoradiotherapy for lung cancer: analysis of data from a prospective clinical trial. Int J Radiat Oncol Biol Phys. 2009 Nov 15;75(4):1092-7. doi: 10.1016/j.ijrobp.2008.12.027. Epub 2009 Mar 26.

  PMID: 19327915 BACKGROUND

• Dang J, Li G, Ma L, Diao R, Zang S, Han C, Zhang S, Yao L. Predictors of grade >/= 2 and grade >/= 3 radiation pneumonitis in patients with locally advanced non-small cell lung cancer treated with three-dimensional conformal radiotherapy. Acta Oncol. 2013 Aug;52(6):1175-80. doi: 10.3109/0284186X.2012.747696. Epub 2012 Dec 3.

  PMID: 23198719 BACKGROUND

• Ji K, Zhao LJ, Liu WS, Liu ZY, Yuan ZY, Pang QS, Wang J, Wang P. Simultaneous integrated boost intensity-modulated radiotherapy for treatment of locally advanced non-small-cell lung cancer: a retrospective clinical study. Br J Radiol. 2014 Mar;87(1035):20130562. doi: 10.1259/bjr.20130562. Epub 2014 Jan 27.

  PMID: 24588668 BACKGROUND

• McDonald S, Rubin P, Phillips TL, Marks LB. Injury to the lung from cancer therapy: clinical syndromes, measurable endpoints, and potential scoring systems. Int J Radiat Oncol Biol Phys. 1995 Mar 30;31(5):1187-203. doi: 10.1016/0360-3016(94)00429-O.

  PMID: 7713782 BACKGROUND

• Barthelemy-Brichant N, Bosquee L, Cataldo D, Corhay JL, Gustin M, Seidel L, Thiry A, Ghaye B, Nizet M, Albert A, Deneufbourg JM, Bartsch P, Nusgens B. Increased IL-6 and TGF-beta1 concentrations in bronchoalveolar lavage fluid associated with thoracic radiotherapy. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):758-67. doi: 10.1016/S0360-3016(03)01614-6.

  PMID: 14967431 BACKGROUND

• Trott KR, Herrmann T, Kasper M. Target cells in radiation pneumopathy. Int J Radiat Oncol Biol Phys. 2004 Feb 1;58(2):463-9. doi: 10.1016/j.ijrobp.2003.09.045.

  PMID: 14751516 BACKGROUND

• Rasmussen L, Arvin A. Chemotherapy-induced immunosuppression. Environ Health Perspect. 1982 Feb;43:21-5. doi: 10.1289/ehp.824321.

  PMID: 7037385 BACKGROUND

• Brambilla C, Romand P, Vanderkerckhove C, Moro D. [Respiratory infection and bronchial cancer]. Rev Mal Respir. 1992;9 Suppl 1:R49-52. French.

  PMID: 1317051 BACKGROUND

• Klastersky J. [The infectious complications of bronchial cancer]. Rev Mal Respir. 1998 Sep;15(4):451-9. French.

  PMID: 9805755 BACKGROUND

• Zhuang H, Yuan Z, Chang JY, Wang J, Pang Q, Zhao L, Wang P. Radiation pneumonitis in patients with non--small-cell lung cancer treated with erlotinib concurrent with thoracic radiotherapy. J Thorac Oncol. 2014 Jun;9(6):882-5. doi: 10.1097/JTO.0000000000000126.

  PMID: 24828665 BACKGROUND

• Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.

  PMID: 23327199 BACKGROUND

• Romani L, Bistoni F, Gaziano R, Bozza S, Montagnoli C, Perruccio K, Pitzurra L, Bellocchio S, Velardi A, Rasi G, Di Francesco P, Garaci E. Thymosin alpha 1 activates dendritic cells for antifungal Th1 resistance through toll-like receptor signaling. Blood. 2004 Jun 1;103(11):4232-9. doi: 10.1182/blood-2003-11-4036. Epub 2004 Feb 24.

  PMID: 14982877 BACKGROUND

• Zheng BX, Cheng DY, Xu G, Fan LL, Yang Y, Yang W. [The prophylactic effect of thymosin alpha 1 on the acute exacerbation of chronic obstructive pulmonary disease]. Sichuan Da Xue Xue Bao Yi Xue Ban. 2008 Jul;39(4):588-90. Chinese.

  PMID: 18798500 BACKGROUND

• Zatloukal P, Petruzelka L, Zemanova M, Havel L, Janku F, Judas L, Kubik A, Krepela E, Fiala P, Pecen L. Concurrent versus sequential chemoradiotherapy with cisplatin and vinorelbine in locally advanced non-small cell lung cancer: a randomized study. Lung Cancer. 2004 Oct;46(1):87-98. doi: 10.1016/j.lungcan.2004.03.004.

  PMID: 15364136 BACKGROUND

Related Links

• 11\. National Comprehensive Cancer Network. (NCCN) Clinical Practice Guidelines in Oncology. Small Cell Lung Cancer, Version

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 6, 2018
• Study Start: August 9, 2018
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

CN (1)