Actively Recruiting
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
Led by Hunan Cancer Hospital · Updated on 2023-07-11
41
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- ECOG performance status of 0 or 1
- Histopathological or cytological confirmation of stage III non-small cell lung cancer
- Disease declared unresectable but suitable for curative radiotherapy by a multidisciplinary team
- Presence of measurable tumors
- Normal major organ function
- Expected survival of at least 6 months
- Female participants of childbearing potential must have a negative serum HCG test before joining
You will not qualify if you...
- Mixed small cell and non-small cell lung cancer diagnosis
- Presence of driver gene mutations like EGFR or ALK
- Previous systemic anti-tumor therapy or immune checkpoint inhibitor treatment for NSCLC
- Prior thoracic radiotherapy
- Participation in other clinical trials within 4 weeks or 5 drug half-lives before study start
- Use of systemic immunostimulants or immunosuppressive therapy before study or expected need during treatment
- Autoimmune diseases
- Other cancers within 5 years except NSCLC
- Known or suspected interstitial pneumonia
- Moderate to severe lung diseases affecting pulmonary function
- Severe cardiovascular or cerebrovascular diseases
- Significant bleeding or bleeding tendency within 1 month before study
- Arteriovenous thrombotic events within 3 months before study
- Positive HIV test
- Active hepatitis B or C
- Active tuberculosis infection within 1 year before study
- Serious infection within 4 weeks before study
- Recent attenuated live vaccination within 28 days before study or planned during study
- Major surgery other than biopsy within 28 days before study
- Previous or planned bone marrow or solid organ transplant
- Severe allergic reactions to monoclonal antibodies or fusion proteins
- Allergy to any study treatment component
- Pregnancy, lactation, or plans to become pregnant during study
- History of psychotropic drug abuse, alcoholism, or drug abuse
- Any other condition making participation inappropriate as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
Research Team
H
Huai Liu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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