Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

Limited Stage Small Cell Lung Cancer Clinical Trial

— SURPASS  

Official title:

A Phase 2/3, Randomized, Double-blind, Placebo-controlled Study of Sugemalimab as Consolidation Therapy in Patients With Limited-stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent or Sequential Chemoradiotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623267
• Other study ID #: B2022-501-01
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 1, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: August 2023
• Source: Sun Yat-sen University
• Contact: Shen Zhao, MD
• Phone: +86-13570917392
• Email: zhaoshen[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the efficacy of sugemalimab consolidation therapy versus placebo in patients with LS-SCLC who had not progressed following Concurrent or Sequential Chemoradiotherapy.

Description:

This study is planned to enroll approximately 346 eligible patients in China. Patients who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to the experimental and control arm. The experimental arm would receive sugemalimab, while the control arm would receive placebo.Tumor assessment will be conducted using computed tomography/magnetic resonance imaging and MRD detection will be performed along with radiologic review during each visit. The above assessment will be conducted every 12 weeks for the first 2 years, every 24 weeks for the third year, and annually thereafter until confirmed disease progression per RECIST 1.1 or death.The primary endpoint is PFS ,which is defined as the time from the date of randomization to the date of disease progression (per RECIST 1.1), any cause of death, loss to follow-up, or initiation of new antitumor therapy, whichever occurred first.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 346
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1?18 years or older. 2?Histologically or cytologically confirmed small cell lung cancer. 3?ECOG PS=0-1 at enrollment; 4?Limited-stage SCLC (Stage I-III, by AJCC 8th Edition Cancer Staging), and can be safely treated with definitive radiation doses). 5?Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery. 6?Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy. 7?After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites. 8?The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy (the first day of the third cycle of chemotherapy). The interval between the end of chemotherapy cycle and beginning of radiotherapy must not exceed 35 days for sequential chemoradiotherapy. 9?Radiotherapy must be either total 60-66Gy over 6 weeks for the standard qd regimen or total 45Gy over 3 weeks for hyperfractionated bid schedules. 10?Absence of progression after concurrent/sequential chemoradiotherapy (responses should be complete response [CR], partial response [PR] and stable disease [SD]); 11?For patients not receiving PCI, the first dose of sugemalimab shall be administered within 42 days after the completion of chemoradiation therapy. For patients receiving PCI, the first dose of sugemalimab shall be administered within 56 days after the completion of chemoradiation therapy. 12?Life expectancy = 12 weeks. 13?Can provide tumor tissue samples (fresh or archived) for whole exome sequencing; 14?Women of childbearing potential and fertile men must agree to use an effective contraceptive method from signing the master ICF until 180 days after the last dose of investigational product. Women of childbearing potential include premenopausal women and women who became menopausal less than 2 years ago. Women of childbearing potential must have a negative pregnancy test =7 days prior to the first dose of investigational product. 15?The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.

Exclusion Criteria:

1. Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.

2. Extensive-stage small cell lung cancer.

3. Has malignant pleural or pericardial effusion.

4. Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.

5. Subjects with active, unstable systemic diseases, such as active infection, uncontrolled hypertension, heart failure (NYHA class >= II), unstable angina pectoris, acute coronary syndrome, severe arrythmia, severe liver, kidney or metabolic diseases, HIV infection.

6. Has history of interstitial lung disease (ILD), drug-induced ILD, or active ILD which required systemic glucocorticoid or immunosuppressive therapy.

7. History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).

8. Pregnant or lactating women.

9. Those who are allergic to the research drug or its components.

10. Subjects who are deemed unable to comply with the study requirements or complete the study.

11. Those with insufficient function of bone marrow or other important organs.

Related Conditions & MeSH terms

• Limited Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Sugemalimab
Recombinant anti-PD-L1 fully human monoclonal antibody
• Placebo
Placebo of Sugemalimab

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (14)

Acheampong E, Abed A, Morici M, Bowyer S, Amanuel B, Lin W, Millward M, Gray ES. Tumour PD-L1 Expression in Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis. Cells. 2020 Oct 31;9(11):2393. doi: 10.3390/cells9112393. — View Citation

Bellmunt J, Hussain M, Gschwend JE, Albers P, Oudard S, Castellano D, Daneshmand S, Nishiyama H, Majchrowicz M, Degaonkar V, Shi Y, Mariathasan S, Grivas P, Drakaki A, O'Donnell PH, Rosenberg JE, Geynisman DM, Petrylak DP, Hoffman-Censits J, Bedke J, Kalebasty AR, Zakharia Y, van der Heijden MS, Sternberg CN, Davarpanah NN, Powles T; IMvigor010 Study Group. Adjuvant atezolizumab versus observation in muscle-invasive urothelial carcinoma (IMvigor010): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2021 Apr;22(4):525-537. doi: 10.1016/S1470-2045(21)00004-8. Epub 2021 Mar 12. — View Citation

Coakley M, Garcia-Murillas I, Turner NC. Molecular Residual Disease and Adjuvant Trial Design in Solid Tumors. Clin Cancer Res. 2019 Oct 15;25(20):6026-6034. doi: 10.1158/1078-0432.CCR-19-0152. Epub 2019 May 14. — View Citation

Faivre-Finn C, Snee M, Ashcroft L, Appel W, Barlesi F, Bhatnagar A, Bezjak A, Cardenal F, Fournel P, Harden S, Le Pechoux C, McMenemin R, Mohammed N, O'Brien M, Pantarotto J, Surmont V, Van Meerbeeck JP, Woll PJ, Lorigan P, Blackhall F; CONVERT Study Team. Concurrent once-daily versus twice-daily chemoradiotherapy in patients with limited-stage small-cell lung cancer (CONVERT): an open-label, phase 3, randomised, superiority trial. Lancet Oncol. 2017 Aug;18(8):1116-1125. doi: 10.1016/S1470-2045(17)30318-2. Epub 2017 Jun 20. — View Citation

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Pignon JP, Arriagada R, Ihde DC, Johnson DH, Perry MC, Souhami RL, Brodin O, Joss RA, Kies MS, Lebeau B, et al. A meta-analysis of thoracic radiotherapy for small-cell lung cancer. N Engl J Med. 1992 Dec 3;327(23):1618-24. doi: 10.1056/NEJM199212033272302. — View Citation

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Tan DS, Camilleri-Broet S, Tan EH, Alifano M, Lim WT, Bobbio A, Zhang S, Ng QS, Ang MK, Iyer NG, Takano A, Lim KH, Regnard JF, Tan P, Broet P. Intertumor heterogeneity of non-small-cell lung carcinomas revealed by multiplexed mutation profiling and integrative genomics. Int J Cancer. 2014 Sep 1;135(5):1092-100. doi: 10.1002/ijc.28750. Epub 2014 Apr 3. — View Citation

The Lancet Oncology. Liquid cancer biopsy: the future of cancer detection? Lancet Oncol. 2016 Feb;17(2):123. doi: 10.1016/S1470-2045(16)00016-4. No abstract available. — View Citation

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Warde P, Payne D. Does thoracic irradiation improve survival and local control in limited-stage small-cell carcinoma of the lung? A meta-analysis. J Clin Oncol. 1992 Jun;10(6):890-5. doi: 10.1200/JCO.1992.10.6.890. — View Citation

Welsh JW, Heymach JV, Guo C, Menon H, Klein K, Cushman TR, Verma V, Hess KR, Shroff G, Tang C, Skoulidis F, Jeter M, Comeaux N, Patel RR, Chen D, Ozgen T, Nguyen QN, Chang JY, Altan M, Zhang J, Papadimitrakopoulou VA, Simon GR, Byers LA, Glisson B. Phase 1/2 Trial of Pembrolizumab and Concurrent Chemoradiation Therapy for Limited-Stage SCLC. J Thorac Oncol. 2020 Dec;15(12):1919-1927. doi: 10.1016/j.jtho.2020.08.022. Epub 2020 Sep 8. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress Free Survival(PFS)	Evaluated according to RECIST 1.1 criteria by researchers.	up to 36 months
Secondary	Overall Survival(OS)		up to 36 months
Secondary	Progress Free Survival rate	Evaluated according to RECIST 1.1 criteria by researchers.	record in 12?18 and 24 months
Secondary	Overall Survival rate	Evaluated according to RECIST 1.1 criteria by researchers.	record in 12?18 and 24 months
Secondary	Objective response rate(ORR)	Evaluated according to RECIST 1.1 criteria by researchers.	up to 36 months
Secondary	Disease control rate(DCR)	Evaluated according to RECIST 1.1 criteria by researchers.	up to 36 months