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

• Status: Not yet recruiting
• Trial end date: 2027-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University

Criteria

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:

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.