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Trial Title:
A Study of AK104 in Subjects With Unresectable Locally Advanced NSCLC
NCT ID:
NCT06617416
Condition:
NSCLC (Non-small Cell Lung Cancer)
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Cadonilimab (AK104)
Description:
AK104 ivgtt Q3W
Arm group label:
AK104 group
Intervention type:
Drug
Intervention name:
Sugemalimab
Description:
1200mg Q3W
Arm group label:
Sugemalimab group
Summary:
This study compares the efficacy and safety of AK104 versus Sugemalimab as consolidation
therapy in patients with unresectable, locally advanced NSCLC who have not progressed
following concurrent or sequential chemoradiotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects must sign the written informed consent form (ICF) voluntarily.
2. Age ≥18 years.
3. Histologically or cytologically confirmed unresectable locally advanced (Stage III)
NSCLC.
4. Absence of known EGFR sensitive mutations and negative for ALK and ROS1 fusions.
5. Concurrent or sequential chemoradiotherapy completed 1 to 42 days prior to the first
dose.
6. Chemotherapy regimens should be in accordance with current clinical guidelines.
7. Consolidation chemotherapy is not allowed after radiotherapy.
8. Total dose of radiotherapy is 60Gy±10% (54Gy-66Gy).
9. No disease progression after concurrent or sequential chemoradiotherapy.
10. ECOG performance status score of 0-1.
11. Expected survival of over 3 months.
12. Adequate organ and bone marrow function.
Exclusion Criteria:
1. The histopathology contains any component of small cell lung cancer.
2. Currently participating in another interventional clinical study.
3. Previously received immunotherapy, biotherapy, anti-angiogenic drugs, or small
molecule targeted drugs.
4. Patients with clinically significant cardio-cerebrovascular or venous thromboembolic
diseases.
5. Prior malignancy active within the previous 3 years except for the locally curable
cancers that have been apparently cured.
6. Tumor invades important vessels or organs.
7. Experienced acute exacerbation of chronic obstructive pulmonary disease or asthma
within 4 weeks prior to the first dose.
8. Presence of interstitial lung disease that requires treatment.
9. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE
version 5.0).
10. Experienced severe infection within 4 weeks prior to the first dose.
11. Underwent major surgery or experienced severe trauma within 4 weeks prior to the
first dose.
12. Any condition that required systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive agents within 14 days prior to
the first dose.
13. Active autoimmune diseases or history of autoimmune diseases that may relapse.
14. Previous history of severe hypersensitivity reactions to other monoclonal
antibodies.
15. Previous organ transplantation or allogeneic hematopoietic stem cell
transplantation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Contact:
Last name:
Jinming Yu, MD
Phone:
+86-0531-87984777
Email:
sdzlllh803@126.com
Start date:
September 30, 2024
Completion date:
December 30, 2028
Lead sponsor:
Agency:
Akeso
Agency class:
Industry
Source:
Akeso
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06617416
