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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: zhaoshen@sysucc.org.cn
• Phone: +86-13570917392

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shrinkage-free combo in LS-SCLC: SHR-7787 plus SHR-1316

  This trial tests whether the combo of SHR-7787 and SHR-1316 can help adults with unresectable limited-stage small cell lung cancer after prior platinum-based chemo and radiation.

  Recruiting Phase 2 Shanghai Hengrui Pharmaceutical Co., Ltd. · Jinan, Shandong · NCT07798947

• Trilaciclib to Protect the Blood System in Limited-Stage Small Cell Lung Cancer

  This trial tests whether trilaciclib can protect blood-forming cells in people with limited-stage small cell lung cancer when given with standard therapy, compared with placebo.

  Recruiting Phase 3 Pharmacosmos A/S · Oakland, California · NCT07473128

• Sugemalimab plus platinum chemotherapy as first-line treatment for advanced NSCLC in routine care

  This will try sugemalimab together with platinum-based chemotherapy as a first-line treatment for adults with locally advanced or metastatic NSCLC.

  Recruiting Peking Union Medical College · Beijing, Beijing Municipality · NCT07247227

• Tarlatamab as maintenance treatment after chemo-radiotherapy for limited-stage small-cell lung cancer.

  This trial will test whether giving tarlatamab after chemo-radiotherapy helps people with limited-stage small-cell lung cancer stay progression-free longer.

  Recruiting at 20 sites Phase 2 Fundación GECP · Albacete, Albacete and 19 other locations · NCT07242547

• Durvalumab consolidation after chemoradiation for limited-stage small-cell lung cancer in China

  This project will test durvalumab given after chemoradiation in people with limited‑stage small‑cell lung cancer who have not progressed, to see how well it works and how safe it is in routine care.

  Recruiting at 20 sites AstraZeneca · Beijing and 20 other locations · NCT07161388

• Sugemalimab with chemotherapy before surgery and continued after for resectable stage II–IIIA non-small cell lung cancer

  This study will test whether giving sugemalimab with chemotherapy before surgery and continuing sugemalimab after surgery helps adults with resectable stage II–IIIA non-small cell lung cancer who do not have EGFR or ALK mutations.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT06987734

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.