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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05623267

Collaborator

(none)

346

Enrollment

Location

Arms

49.9

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Limited Stage Small Cell Lung Cancer	Drug: Sugemalimab Drug: Placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

346 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Mar 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Progress Free Survival(PFS) [up to 36 months]
Evaluated according to RECIST 1.1 criteria by IRC.

Secondary Outcome Measures

Overall Survival(OS) [up to 36 months]
Evaluated according to RECIST 1.1 criteria by researchers.
Progress Free Survival rate [record in 12、18 and 24 months]
Evaluated according to RECIST 1.1 criteria by researchers.
Overall Survival rate [record in 12、18 and 24 months]
Evaluated according to RECIST 1.1 criteria by researchers.
Objective response rate(ORR) [up to 36 months]
Evaluated according to RECIST 1.1 criteria by researchers.
Disease control rate(DCR) [up to 36 months]
Evaluated according to RECIST 1.1 criteria by researchers.
Investigator-assessed progression-free survival (PFS) [up to 36 months]
Evaluated according to RECIST 1.1 criteria by researchers.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1、18 years or older. 2、Histologically or cytologically confirmed small cell lung cancer. 3、ECOG PS=0-1 at enrollment; for patients with PS=2, if the poor performance status is caused by the tumor, and the investigators believe that the patient's performance status can be improved after the first chemotherapy, they can be enrolled according to the investigator's judgment. Patients with poor performance status (PS=2) due to comorbidities were excluded.

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 4-6 cycles of chemotherapy (etoposide + carboplatin/cisplatin) concurrent or sequential with radiotherapy during the first two cycles of chemotherapy.

7、Radiotherapy must be initiated no later than the last day of the second cycle of chemotherapy.

8、The start of concurrent radiotherapy should be no later than the last day of the second course of chemotherapy， 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、The first dose of sugemalimab can be administered within 42 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、Forced expiratory volume in first second FEV1>50% predicted value and diffusing capacity of the lung for carbon monoxide DLCO>40% predicted normal value according to pulmonary function test; if the subject does not meet the above criteria, and inhaled steroids and bronchodilators could be used according to clinical indications, reassessment for eligibility could be conducted after 1-2 weeks.

15、The subject should have good compliance, who would participate in the research voluntarily, and sign the informed consent； 16、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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060

Sponsors and Collaborators

Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Li Zhang, MD, Chief of Internal Medicine, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT05623267

Other Study ID Numbers:

B2022-501-01

First Posted:

Nov 21, 2022

Last Update Posted:

Nov 21, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Li Zhang, MD, Chief of Internal Medicine, Sun Yat-sen University

Limited-stage Small-cell Lung Cancer（LS-SCLC）

Minimal Residual Disease（MRD）

Immunotherapy

Additional relevant MeSH terms:

Lung Neoplasms

Small Cell Lung Carcinoma

Study Results

No Results Posted as of Nov 21, 2022