Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406673
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-05-06
Brief Title:
A Phase II Clinical Study of Cadonilimab in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
A Phase II Clinical Study of CadonilimabPD-1CTLA-4 Bi-Specific Antibody in Treatment-naïve or Relapsed Extensive Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Small cell lung cancer SCLC accounts for 15 of lung cancer cases and is an aggressive cancer characterized by rapid growth early metastasis and a poor prognosis Approximately 75 of SCLC patients present with extensive-stage disease at the time of diagnosis which is classically defined as a disease that cannot be encompassed by a single radiation field Before the era of immunotherapy the standard first-line therapy for ES-SCLC was platinum-based chemotherapy with etoposide Once complete remission CR or partial remission PR was achieved after chemotherapy consolidative thoracic radiation was recommended Despite this standard treatment the median overall survival OS of ES-SCLC is about 8-11 months which has not changed for about 40 years Combining concurrent radiotherapy of the thorax and immunochemotherapy may have a synergistic effect
Besides for patients with recurrent SCLC topotecan remains the only approved second-line treatment and the outcomes are poor With the most recent approval of EP plus a programmed death ligand 1PD-L1 inhibitor there are now more therapeutic options for managing ES-SCLCThe best second-line therapy after combination of chemo-immunotherapy is not well defined as many second-line therapies were studied only after use of EP However second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP with or without an immunotherapy lurbinectedin and topotecan
Therefore we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC We present a safety profile and a final analysis of ORR
In this single-center phase 2 trial Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with ECEP for two cycles induction phase then those who did not progress received concurrent palliative RT and two cycles of cadonilimab with ECEP combination phase Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment maintenance phase Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib until disease progression or unacceptable toxicity
The primary endpoints was objective response rate ORR the second endpoints were progression-free survival PFS disease control rate DCR overall survival OS and treatment-emergent adverse event TEAE
Besides for patients with recurrent SCLC topotecan remains the only approved second-line treatment and the outcomes are poor With the most recent approval of EP plus a programmed death ligand 1PD-L1 inhibitor there are now more therapeutic options for managing ES-SCLCThe best second-line therapy after combination of chemo-immunotherapy is not well defined as many second-line therapies were studied only after use of EP However second-line treatment options for patients with relapsed ES-SCLC are limited and include reintroduction of EP with or without an immunotherapy lurbinectedin and topotecan
Therefore we designed this trial to explore the efficacy and safety of cadonilimab as second-line therapy for ES-SCLC We present a safety profile and a final analysis of ORR
In this single-center phase 2 trial Cohort_1 patients with no history of previous systemic treatment for ES-SCLC received cadonilimab with ECEP for two cycles induction phase then those who did not progress received concurrent palliative RT and two cycles of cadonilimab with ECEP combination phase Afterward they received cadonilimab every 3 weeks for a maximum of 2 years after study enrolment maintenance phase Cohort_2 patients with recurrent SCLC and after at most one systemic treatment received cadonilimab plus vorolanib until disease progression or unacceptable toxicity
The primary endpoints was objective response rate ORR the second endpoints were progression-free survival PFS disease control rate DCR overall survival OS and treatment-emergent adverse event TEAE
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None