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

NCT05623267 | Recruiting Phase 2

• 1 other identifier: B2022-501-01
• Study Type: interventional
• Target: 346
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Limited Stage Small Cell Lung Cancer

Keywords

Limited-stage Small-cell Lung Cancer（LS-SCLC）; Minimal Residual Disease（MRD）; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival(PFS)

  Evaluated according to RECIST 1.1 criteria by researchers.

  up to 36 months

Secondary Outcomes (5)

• Overall Survival(OS)

  up to 36 months

• Progress Free Survival rate

  record in 12、18 and 24 months

• Overall Survival rate

  record in 12、18 and 24 months

• Objective response rate(ORR)

  up to 36 months

• Disease control rate(DCR)

  up to 36 months

Study Arms (2)

Experimental arm

EXPERIMENTAL

Intravenous infusion (IV) of Sugemalimab 1200 mg at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity.

Drug: Sugemalimab

Control arm

PLACEBO COMPARATOR

Intravenous infusion (IV) of placebo at least 60 minutes on Day 1 of each treatment cycle, every 3 weeks (21 days), for 1 year or until disease progression or intolerable toxicity.

Drug: Placebo

Interventions

Sugemalimab DRUG

Recombinant anti-PD-L1 fully human monoclonal antibody

Experimental arm

Placebo DRUG

Placebo of Sugemalimab

Control arm

Eligibility Criteria

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

You may qualify if:

• 、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).
• 、Inoperable SCLC, or the patient has contraindications to surgery, or the patient refuses surgery.
• 、Completion of 4 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy.
• 、After the completion of concurrent or sequential chemoradiotherapy, prophylactic intracranial irradiation (PCI) is allowed based on the common practice of individual sites.
• 、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.
• 、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.
• 、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.
• 、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.
• 、The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent.

You may not qualify if:

• Histologically or cytologically diagnosed mixed small cell lung cancer or non-small cell lung cancer.
• Extensive-stage small cell lung cancer.
• Has malignant pleural or pericardial effusion.
• Previously received systemic anti-tumor therapy for SCLC or anti-tumor therapy with immune checkpoint inhibitors.
• 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.
• Has history of interstitial lung disease (ILD), drug-induced ILD, or active ILD which required systemic glucocorticoid or immunosuppressive therapy.
• History of other malignancies within 5 years (excluding basal cell carcinoma of the skin or other carcinoma in situ that has been resected).
• Pregnant or lactating women.
• Those who are allergic to the research drug or its components.
• Subjects who are deemed unable to comply with the study requirements or complete the study.
• Those with insufficient function of bone marrow or other important organs.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (15)

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  PMID: 37442748 DERIVED

MeSH Terms

Conditions

Neoplasm, Residual

Interventions

sugemalimab

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Zhang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Yan Huang, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shen Zhao, MD

CONTACT

+86-13570917392; zhaoshen@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Internal Medicine

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: November 21, 2022
• Study Start: July 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)