Actively Recruiting
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2024-09-19
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying locally advanced non-small cell lung cancer (NSCLC) that cannot be removed by surgery initially. The trial evaluates whether adding surgery after chemoimmunotherapy improves survival and safety compared to chemoimmunotherapy followed by radiotherapy or continued non-surgical therapy. This is an open-label, randomized, phase 2 trial sponsored by Shanghai Pulmonary Hospital, China. Participants receive four cycles of chemoimmunotherapy with serplulimab (a PD-1 antibody) combined with platinum-based doublet chemotherapy including nab-paclitaxel or pemetrexed plus carboplatin. Patients whose tumors shrink enough to become operable are randomly assigned to surgery or radiotherapy. Those with tumors still unresectable after chemoimmunotherapy continue non-surgical treatments in oncology. During the study, patients undergo imaging tests to confirm tumor status, and assessments include event-free survival measured up to 30 months. Additional outcomes such as response rate, progression-free survival, disease-free survival, overall survival, safety events, and quality of life are monitored over up to 60 months. Researchers also track adverse events and lung function, with follow-up visits scheduled regularly to evaluate health and treatment effects throughout the study period.
CONDITIONS
Brief 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...
- The patient has signed the Informed Consent Form.
- Age 18 years or older.
- Histological or cytological diagnosis of non-small cell lung cancer confirmed by biopsy.
- Stage IIIB or IIIC confirmed by imaging (CT, PET-CT, or EBUS).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Life expectancy of at least 12 weeks.
- At least one measurable tumor lesion per RECIST 1.1 criteria.
- Good function of major organs such as liver, kidney, and blood system.
- Normal lung function sufficient to tolerate surgery.
- No systemic metastasis (including M1a, M1b, M1c).
- Fertile female patients must use effective contraception during study and for at least 120 days after last chemotherapy or serplulimab dose.
- Unsterilized male patients must use effective contraception during study and for at least 120 days after last chemotherapy or serplulimab dose.
You will not qualify if you...
- Prior systemic anti-cancer treatment for thymic epithelial tumor, including surgery, radiotherapy, chemotherapy, targeted therapy, or experimental treatments.
- Unstable systemic diseases such as active infection, uncontrolled hypertension, recent angina, congestive heart failure, recent myocardial infarction, severe arrhythmia, liver, kidney, or metabolic diseases.
- Active or suspected autoimmune disease or autoimmune paraneoplastic syndrome requiring systemic treatment.
- Allergy to study drugs or their components.
- Current interstitial lung disease.
- Active hepatitis B, hepatitis C, or HIV infection.
- Pregnant or breastfeeding women.
- Nervous system or mental diseases that impair cooperation.
- Participation in another therapeutic clinical study.
- Other conditions deemed unsuitable by researchers.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 cycles
Participants receive induction therapy with PD-1 antibody combined with platinum-based doublet chemotherapy for up to 4 cycles.
Visits for each treatment cycle over approximately 12 weeks
Duration - Up to 1 month
Participants with tumors downstaged and resectable after chemoimmunotherapy receive surgical treatment and immediate post-operative care in the thoracic surgery department.
Approximately 1 to 2 visits during post-operative care
Duration - Duration of radiotherapy as per clinical schedule
Participants with tumors downstaged and resectable after chemoimmunotherapy receive radiotherapy in the medical oncology department.
Multiple radiotherapy sessions as scheduled
Duration - As per treatment plan in medical oncology
Participants with unresectable tumors after chemoimmunotherapy receive non-surgical therapy in the medical oncology department.
Visits according to therapy schedule
Duration - Up to 30 months
Participants are monitored for event-free survival and other outcomes after completing treatment.
Regular follow-up visits for up to 30 months
Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China, 200433
Actively Recruiting
Research Team
P
Peng Zhang, PhD
S
Suyu Wang
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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