NCT05901584

Cadonilimab (AK104) With or Without CT as 2rd Line Treatment for ES-SCLC

A Single-arm Multicenter Phase II Clinical Trial of Cadunilumab (Anti-PD-1/CTLA-4) in Combination With or Without Chemotherapy in Second-line Treatment for Patients With Extensive Stage Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Second Affiliated Hospital of Zunyi Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase II clinical study of Cadonilimab (AK104) combined with or without chemotherapy in the treatment of PD-1 inhibitor-resistant extensive stage small cell lung cancer

Detailed description

This study is conducted by enrolling subjects with ES-SCLC who have previously failed first-line systemic therapy (platinum-containing chemotherapy in combination with or without atezolizumab and dulvalizumab), and all enrolled subjects will receive cadunilumab alone or in combination with chemotherapy and continue treatment in 3-week dosing cycles until toxicity is intolerable, there is no longer clinical benefit in the judgment of the investigator (in the investigator's judgment based on RECISTv1.1 imaging assessment and clinical status, etc.), completion of 24 months of treatment, or other criteria for termination of treatment in the protocol are met, whichever occurs first. Patients were observed for efficacy and side effects. Primary outcome: progression-free survival (PFS) based on RECIST v1.1 assessment. Secondary outcomes included: incidence and severity of adverse events; objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), time to remission (TTR), and overall survival (OS). Finally, mRNA expression profiles in tumor tissue samples were determined by gene sequencing to analyze the correlation between molecular subtypes of small cell lung cancer, immune-related gene characteristics and efficacy.

Conditions

• Immunotherapy
• Second-line Treatment

Interventions

Type	Name	Description
DRUG	Cadonilimab	Cadonilimab (10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit)+platinum-based chemotherapy or Cadonilimab (10mg/kg, administered on the first day of each cycle, Q3W, until there is no clinical benefit), Q3W, 4cycles), every 3 weeks (21 days) is a treatment cycle.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2023-06-13
• Last updated: 2023-06-18

Locations

1 site across 1 country: China