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

August 4, 2023 updated by: Li Zhang, MD, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

346

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm
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
Recombinant anti-PD-L1 fully human monoclonal antibody
Placebo Comparator: Control arm
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
Placebo of Sugemalimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival(PFS)
Time Frame: up to 36 months
Evaluated according to RECIST 1.1 criteria by researchers.
up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival rate
Time Frame: record in 12、18 and 24 months
Evaluated according to RECIST 1.1 criteria by researchers.
record in 12、18 and 24 months
Overall Survival rate
Time Frame: record in 12、18 and 24 months
Evaluated according to RECIST 1.1 criteria by researchers.
record in 12、18 and 24 months
Objective response rate(ORR)
Time Frame: up to 36 months
Evaluated according to RECIST 1.1 criteria by researchers.
up to 36 months
Disease control rate(DCR)
Time Frame: up to 36 months
Evaluated according to RECIST 1.1 criteria by researchers.
up to 36 months
Overall Survival(OS)
Time Frame: up to 36 months
up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Li Zhang, MD, Sun Yat-sen University
  • Principal Investigator: Yan Huang, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

November 12, 2022

First Submitted That Met QC Criteria

November 12, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-501-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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