Back to resultsCadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cadonilimab
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
Key Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function. Key Exclusion Criteria: Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. Presence of other uncontrolled serious medical conditions.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cadonilimab
Arm Description
Participants receive two cycles of Cadonilimab as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- adjuvant Cadonilimab for 6 months.
Outcomes
Primary Outcome Measures
Major Pathological Response (MPR) Rate
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy
Secondary Outcome Measures
Pathological Complete Response (pCR) Rate
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy
Complete (R0) Resection Rate
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Objective Response Rate (ORR)
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Disease Free Survival (DFS)
defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Adverse Events (AEs)
Full Information
NCT ID
NCT05784974
First Posted
March 10, 2023
Last Updated
March 23, 2023
Sponsor
The First Hospital of Jilin University
1. Study Identification
Unique Protocol Identification Number
NCT05784974
Brief Title
Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
Official Title
An Open-label, Single-center, Phase II Study of Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cadonilimab
Arm Type
Experimental
Arm Description
Participants receive two cycles of Cadonilimab as neoadjuvant therapy prior to surgery; followed by surgery; followed by standard adjuvant chemotherapy +/- adjuvant Cadonilimab for 6 months.
Intervention Type
Drug
Intervention Name(s)
Cadonilimab
Intervention Description
15 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Major Pathological Response (MPR) Rate
Description
defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy
Time Frame
After surgery (approximately 7 weeks)
Secondary Outcome Measure Information:
Title
Pathological Complete Response (pCR) Rate
Description
defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy
Time Frame
After surgery (approximately 7 weeks)
Title
Complete (R0) Resection Rate
Description
defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.
Time Frame
After surgery (approximately 7 weeks)
Title
Objective Response Rate (ORR)
Description
defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.
Time Frame
At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)
Title
Disease Free Survival (DFS)
Description
defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.
Time Frame
Up to approximately 5 years
Title
Adverse Events (AEs)
Time Frame
From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer.
Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function.
Key Exclusion Criteria:
Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
Presence of other uncontrolled serious medical conditions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kewei Ma
Phone
0431-88782179
Email
makw@jlu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
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