Actively Recruiting
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
Led by Northern Jiangsu People's Hospital · Updated on 2023-10-04
20
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
Sponsors
N
Northern Jiangsu People's Hospital
Lead Sponsor
S
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
CONDITIONS
Official Title
Neoadjuvant Triprizumab and Radiotherapy in Operable Patients With Stage IIA-IIIA Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must volunteer and sign informed consent
- Aged 18 to 70 years, any gender
- Histologically confirmed resectable stage IIA to IIIA NSCLC without prior treatment
- Must have at least one target lesion for response assessment
- Agree to provide PD-L1 tissue samples and pathology reports for biomarker evaluation
- ECOG performance status of 0 or 1
- Good organ function including ANC ≥1500/µL, PLT ≥100000/µL, HB ≥10.0 g/dL, creatinine ≤1.5×ULN or CrCl ≥60 mL/min
- Total bilirubin ≤1.5×ULN or normal direct bilirubin if total bilirubin is elevated
- AST and ALT ≤2.5×ULN
- Normal thyroid stimulating hormone or normal T3 and free T4 if TSH abnormal
- INR, PT, and APTT ≤1.5×ULN
- Able to follow research visits, treatment plans, and tests
- Lung function must allow proposed lung surgery
- Fertile women must have negative hCG test within 3 days before medication and agree to use effective contraception during the study and for 180 days after last dose
You will not qualify if you...
- Locally advanced unresectable or metastatic disease
- Non-NSCLC lung cancers like upper sulcus tumors, large cell neuroendocrine cancer, or sarcomatoid tumor
- Known EGFR mutations or ALK translocations
- Prior systemic anticancer therapy for early NSCLC
- History or current pneumonia/interstitial lung disease requiring steroid therapy
- Active tuberculosis or active infections needing systemic treatment
- Known or suspected autoimmune disease or immunodeficiency (except stable hypothyroidism or controlled type 1 diabetes)
- Active hepatitis B or C
- Known HIV infection
- Received live vaccine within 30 days before drug administration
- Peripheral neuropathy grade 2 or higher
- Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- Severe allergies to certain chemotherapy drugs
- Serious or uncontrolled underlying diseases
- Any condition that may interfere with participation or safety as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
People's hospital of northern jiangsu
Yangzhou, Jiangsu, China, 225000
Actively Recruiting
Research Team
W
Wang Buhai, doctor
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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