Actively Recruiting
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.
CONDITIONS
Official Title
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has signed the Informed Consent Form.
- Age is 18 years or older.
- Confirmed diagnosis of non-small cell lung cancer (NSCLC) stage IIIB-IIIC by biopsy and imaging (CT, PET-CT or EBUS).
- Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable lesion according to RECIST 1.1 criteria.
- Good function of main organs including liver, kidney, and blood system.
- Normal lung function sufficient to tolerate surgery.
- No evidence of systemic metastasis (M1a, M1b, M1c).
- Fertile female patients must use effective contraception for at least 120 days after chemotherapy or last serplulimab dose, and have negative pregnancy tests within 7 days before enrollment.
- Unsterilized male patients must use effective contraception during the study and for at least 120 days after chemotherapy or last serplulimab dose.
You will not qualify if you...
- Prior systemic anti-cancer treatment for thymic epithelial tumor including surgery, radiotherapy, cytotoxic drugs, targeted therapy, or experimental treatments.
- Unstable systemic diseases such as active infection, uncontrolled hypertension, recent angina (within 3 months), congestive heart failure (NYHA Grade II or higher), recent myocardial infarction (within 6 months), severe arrhythmia requiring medication, or significant liver, kidney, or metabolic disorders.
- Active or suspected autoimmune disease or autoimmune paraneoplastic syndrome requiring systemic treatment.
- Allergies to the study drug or its components.
- Current interstitial lung disease.
- Active hepatitis B, hepatitis C, or HIV infection.
- Pregnant or breastfeeding women.
- Neurological or mental disorders that impair cooperation.
- Participation in another therapeutic clinical trial.
- Other conditions deemed unsuitable for enrollment by the researchers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
P
Peng Zhang, PhD
CONTACT
S
Suyu Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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