Neoadjuvant or Adjuvant Cadonilimab (PD-1/CTLA-4 Bispecific Antibody) Plus Chemotherapy in Patients With Resectable Stage IB (≥4 cm) to IIIB(N2) PD-L1 Negative Non-small Cell Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Age ≥ 18 years and ≤ 70 years

• Patients with non-small cell lung cancer diagnosed by pathologic histology or cytology, and the primary focus or lymph node metastasis test is clearly negative for EGFR/ALK/ROS1;

• Tumor tissue PD-L1 expression TPS \<1%

• Patients with resectable stage IB (≥4 cm) to IIIB (N2) NSCLC (according to the staging criteria of the American Joint Committee on Cancer, 7th edition)

• Eastern Cooperative Oncology Group performance-status score of 0 or 1

• No previous anticancer therapy

• Patients had to have measurable disease according to the Response Evaluation Criteria in Solid Tumors, version 1.1, and pretreatment tumor tissue available to assess the expression of programmed death ligand 1 (PD-L1)

• Normal function of major organs

Locations
Other Locations
China
Sichuan Provincial Tumor Hospital
RECRUITING
Chengdu
Contact Information
Primary
Li Juan, Ph.D
dr.lijuan@hotmail.com
138 8027 6636
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 20
Treatments
Experimental: Experimental: Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel +Carboplatin
Drug:Cadonilimab +Paclitaxel/ Albumin-bound paclitaxel+Carboplatin neoadjuvant chemotherapy\[Cadonilimab, 10mg/kg ,d1,q3w; Paclitaxel 175mg/m2 ivgtt d1/Albumin-bound paclitaxel 260mg/m2,ivgtt(\>30min) ,d1,q3w; carboplatin AUC 5 ivgtt d1, q3w\] for 3 cycles.The patient was evaluated after 3 cycles of neoadjuvant chemotherapy. The surgery was performed 3-6 weeks after the completion of neoadjuvant chemotherapy. After surgery patients could receive up to 12 months of adjuvant chemotherapy.
Sponsors
Leads: Sichuan Cancer Hospital and Research Institute

This content was sourced from clinicaltrials.gov

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