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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
30
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.
The Second Affiliated Hospital of Zunyi Medical University
Guizhou, ZunYi, China
RECRUITINGProgression-free survival,PFS
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST v i I Assessed PFS
Time frame: Time Frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
Overall Survival,OS
The time from the patient receiving treatment to the death of the patient for any reason,OS evaluated according to RECIST vi. I
Time frame: 3 years
Objective Response Rate,ORR
The proportion of patients whose tumor volume is reduced to 30% and can be maintained for more than 4 weeks,Based on RECIST v i I Assessed ORR
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression)
Disease control rate,DCR
Includes complete remission, partial remission, and stable disease maintained for more than 4 weeks as a percentage of patients with evaluable outcomes
Time frame: The last subject completes at least 24 weeks of follow-up (or disease progression
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