Combining Sugemalimab with Chemotherapy for Advanced Lung Cancer

A Single-arm Phase 2 Study of Sugemalimab and Chemotherapy as Induction Therapy in Unresectable and Stage III Non-small Cell Lung Cancer (NSCLC)

This study is testing if combining a new drug called Sugemalimab with chemotherapy can help people with advanced lung cancer that can't be surgically removed feel better and improve their chances of recovery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 41 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hunan Cancer Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Changsha)
• Trial ID: NCT05940532 on ClinicalTrials.gov

What this trial studies

This phase II, open-label, single-arm study aims to assess the effectiveness and safety of using Sugemalimab in conjunction with chemotherapy for patients with unresectable stage III non-small cell lung cancer (NSCLC). The approach involves administering induction immunotherapy and chemotherapy, followed by treatment guided by a multidisciplinary team, which may include radiotherapy or surgery. The study focuses on patients whose disease is confirmed as unresectable but can still be treated with curative intent. The goal is to improve patient outcomes in this challenging cancer stage.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable stage III non-small cell lung cancer and a good performance status.

Not a fit: Patients with mixed small cell and non-small cell lung cancer or those with specific driver gene mutations may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced lung cancer that is currently difficult to treat.

How similar studies have performed: While there have been studies exploring immunotherapy and chemotherapy combinations, this specific approach in unresectable stage III NSCLC is relatively novel.

Eligibility criteria

Inclusion Criteria:

1.18 to 75 years old, both male and female;

2.ECOG score: 0-1;

3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;

4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;

5.Measurable lesions available;

6.Major organ function is basically normal;

7.Estimated survival time is at least 6 months;

8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.

Exclusion Criteria:

1. Histologically or cytologically confirmed mixed SCLC and NSCLC;
2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
4. Previous thoracic radiotherapy;
5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
6. Systemic immunostimulant therapy before the first dose;
7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
8. Subjects with autoimmune diseases;
9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
10. Known or suspected interstitial pneumonia;
11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
12. Severe cardiovascular and cerebrovascular diseases;
13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
14. Arteriovenous thrombotic events within 3 months before the first dose;
15. Positive HIV test;
16. Active hepatitis B or C;
17. Evidence of active tuberculosis infection within 1 year before the first dose;
18. Serious infection within 4 weeks before the first dose;
19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
22. History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
23. Allergic to any component of the randomized treatment regimen;
24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate.

Where this trial is running

Changsha

• Hunan Cancer Hospital — Changsha, China (RECRUITING)

Study contacts

• Principal investigator: Hui Wang, MD — the Department of Radiation Oncology
• Study coordinator: Huai Liu, MD

Conditions: Carcinoma, Non-Small-Cell Lung, immunotherapy, chemotherapy, radiotherapy, surgery, non-small cell lung cancer