Using sugemalimab to treat limited stage small cell lung cancer after chemotherapy and radiotherapy

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

This study is testing if the drug sugemalimab can help people with limited stage small cell lung cancer stay cancer-free after they have completed chemotherapy and radiotherapy.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 346 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: sugemalimab, chemotherapy, radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05623267 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of sugemalimab as a consolidation therapy compared to a placebo in patients with limited stage small cell lung cancer (LS-SCLC) who have not experienced disease progression after concurrent or sequential chemoradiotherapy. Approximately 346 eligible patients will be enrolled and randomly assigned to receive either sugemalimab or a placebo. Tumor assessments will be conducted regularly using imaging techniques and minimal residual disease detection. The primary goal is to measure progression-free survival (PFS) over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed limited-stage small cell lung cancer who have completed chemotherapy and radiotherapy.

Not a fit: Patients with advanced-stage small cell lung cancer or those who have progressed after initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve disease control and survival rates for patients with LS-SCLC.

How similar studies have performed: Other studies have shown promising results with immunotherapy approaches in small cell lung cancer, suggesting potential for success in this novel application.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Li Zhang, MD — Sun Yat-sen University
• Study coordinator: Shen Zhao, MD

Conditions: Limited Stage Small Cell Lung Cancer, Limited-stage Small-cell Lung Cancer（LS-SCLC）, Minimal Residual Disease（MRD）, Immunotherapy