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

Status Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05901584
Study type	Interventional
Source	Second Affiliated Hospital of Zunyi Medical University
Contact	Hu Ma, Ph.D
Phone	18115068816
Email	mahuab@163.com
Status	Recruiting
Phase	Phase 2
Start date	January 1, 2023
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05848011` - A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer	Phase 2
Recruiting	`NCT05161572` - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer	Phase 2
Recruiting	`NCT06165900` - Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC	Phase 2
Recruiting	`NCT06120127` - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence	Phase 2
Recruiting	`NCT06262581` - Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery	Phase 2
Recruiting	`NCT05176002` - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma.	Phase 1/Phase 2
Not yet recruiting	`NCT05909137` - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting	`NCT04500990` - MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Not yet recruiting	`NCT04372732` - Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Completed	`NCT02692976` - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients	Phase 2
Completed	`NCT03763630` - MAPS & ITEC Cohorts: 6-8 Years Follow-up	Phase 2
Not yet recruiting	`NCT06012318` - Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Not yet recruiting	`NCT05479240` - Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer	Phase 2
Recruiting	`NCT05515796` - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors	Phase 2
Recruiting	`NCT04711330` - Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
Recruiting	`NCT03701607` - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting	`NCT03683407` - Effect of Chemotherapy on TMB in NSCLC
Completed	`NCT03357861` - Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Recruiting	`NCT05223088` - Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer	Phase 2
Completed	`NCT05657262` - Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas	N/A