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Trial Title:
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
NCT ID:
NCT05940532
Condition:
Carcinoma, Non-Small-Cell Lung
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
immunotherapy
chemotherapy
radiotherapy
surgery
non-small cell lung cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sugemalimab and Chemotherapy
Description:
Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC;
Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC;
intravenous infusion every 3 weeks, for up to four cycles.
Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years.
Arm group label:
Interventional arm
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Huai Liu, MD
Phone:
+8619918909231
Email:
liuhuai@hnca.org.cn
Start date:
June 14, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
Hunan Cancer Hospital
Agency class:
Other
Source:
Hunan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05940532
