Actively Recruiting
Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC
Led by Sichuan Cancer Hospital and Research Institute · Updated on 2024-12-20
20
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to observe and evaluate the efficacy and safety of cadonilimab combined with chemotherapy in patients with resectable IB (≥ 4cm) - IIIB (N2) stage PD-L1 negative non-small cell lung cancer
CONDITIONS
Official Title
Neoadjuvant/Adjuvant Cadonilimab Plus Chemotherapy in Patients With Resectable PD-L1 Negative NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years to 70 years
- Diagnosed with non-small cell lung cancer by pathology or cytology
- Tumor or lymph node negative for EGFR/ALK/ROS1 mutations
- Tumor tissue PD-L1 expression less than 1%
- Resectable stage IB (tumor 8 cm) to IIIB (N2) NSCLC
- Eastern Cooperative Oncology Group performance status of 0 or 1
- No previous anticancer treatment
- Measurable disease per RECIST 1.1 criteria
- Available pretreatment tumor tissue for PD-L1 assessment
- Normal function of major organs
You will not qualify if you...
- Large cell carcinoma or mixed cell lung cancer with small cell components
- Locally advanced unresectable or metastatic disease
- Tumor invading vital vessels or high risk of fatal hemorrhage
- Significant cavitating or necrotic tumor in the lung
- Prior systemic anticancer therapy for NSCLC
- Prior localized radiotherapy for NSCLC
- Cancer other than NSCLC within 5 years, except certain cured skin and bladder cancers
- Allergy to cadonilimab or chemotherapy components
- Severe or uncontrolled diseases
- Previous or active interstitial lung disease
- Stroke or pulmonary embolism within 6 months
- Peripheral neuropathy grade 2 or higher, except trauma related
- Requirement for total right lung removal
- Major surgery or severe trauma within 14 days before enrollment
- Participation in another clinical trial or within 4 weeks after prior trial
- Severe hypersensitivity to monoclonal antibodies
- Pregnant or breastfeeding women
- History of serious neurologic or psychiatric disorders
- Other factors judged by investigator as safety risks or affecting study data collection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Li Juan, Ph.D
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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