NCT05940532 A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
| NCT ID | NCT05940532 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Cancer Hospital |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Study Type | INTERVENTIONAL |
| Enrollment | 41 participants |
| Start Date | 2023-06-14 |
| Primary Completion | 2025-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 41 participants in total. It began in 2023-06-14 with a primary completion date of 2025-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
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.
Contact & Investigator
Hui Wang, MD
PRINCIPAL INVESTIGATOR
the Department of Radiation Oncology
Frequently Asked Questions
Who can join the NCT05940532 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Carcinoma, Non-Small-Cell Lung. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05940532 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05940532 currently recruiting?
Yes, NCT05940532 is actively recruiting participants. Contact the research team at liuhuai@hnca.org.cn for enrollment information.
Where is the NCT05940532 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05940532 clinical trial?
NCT05940532 is sponsored by Hunan Cancer Hospital. The principal investigator is Hui Wang, MD at the Department of Radiation Oncology. The trial plans to enroll 41 participants.