Actively Recruiting
Cadonilimab Plus Chemotherapy Before and After Surgery in Patients With Resectable Stage IB to IIIB PD-L1 Negative Non-Small Cell Lung Cancer
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
Researchers are evaluating the safety and effectiveness of cadonilimab combined with chemotherapy in patients with resectable stage IB (tumors 8 cm) to IIIB (N2) non-small cell lung cancer (NSCLC) who test negative for PD-L1. This phase 2 clinical trial focuses on patients whose tumors do not express PD-L1 and who have not received prior anticancer therapy, aiming to improve treatment outcomes in this group. Participants receive three cycles of neoadjuvant chemotherapy including cadonilimab, paclitaxel or albumin-bound paclitaxel, and carboplatin. Surgery is scheduled 3 to 6 weeks after completing neoadjuvant chemotherapy. After surgery, patients may receive up to 12 months of adjuvant chemotherapy to further treat the disease. During the study, participants undergo assessments to monitor tumor response, safety, and side effects. The major pathological response (MPR) is measured at the time of surgery to evaluate treatment impact. Researchers also monitor organ function and overall health throughout treatment. The total duration of participation includes the pre-surgery chemotherapy cycles, surgery, and the possible year-long adjuvant chemotherapy phase.
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
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Trial Site Locations
Total: 1 location
1
Sichuan Provincial Tumor Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
L
Li Juan, Ph.D
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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