Small Cell Lung Cancer
Conditions
Keywords
AK112, Ivonescimab
Brief summary
This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK112 to placebo as consolidation treatment for patients with limited stage small cell lung cancer who have not progressed following concurrent chemoradiation therapy.
Interventions
DRUGAK112
AK112 20mg/kg, intravenous \[IV\]),Q3W
OTHERPlacebo
Placebo, intravenous \[IV\]),Q3W
Sponsors
Akeso
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. The subjects voluntarily participated in the study with full informed consent and signed written informed consent form. 2. Aged ≥18 years on day fo signing the informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 3 months 5. Histologically or cytologically confirmed small cell lung cancer. 6. Documented limited-stage SCLC (Stage I-III SCLC \[T any, N any, M0\] according to the American Joint Committee on Cancer Staging Manual \[AJCC Cancer Staging Manual, 8th Edition\] or the Veterans Administration Lung Study Group (VALG) stage. 7. Have Received concurrent chemoradiotherapy regimen as defined in protocol and have not progressed following concurrent chemoradiotherapy. 8. Adequate organ function. 9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.
Exclusion criteria
1. Histologically or cytological confirmed the presence of mixed small cell lung cancer or non-small cell lung cancer components. 2. Toxicities from previous anti-tumor treatments have not resolved to grade 0 or 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0), or to the levels specified in inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival(PFS) assessed by Blinded independent center review(BIRC) | Approximately 6 years | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1 |
| Overall Survival (OS) | Approximately 6 years | OS is defined as the time from randomization or first dosing to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by investigator per RECIST v1.1 | Approximately 6 years | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST v1.1 |
| Objective Response Rate (ORR) assessed by BICR Per RECIST v1.1 | Approximately 6 years | — |
| ORR assessed by investigator Per RECIST v1.1 | Approximately 6 years | — |
| Disease control rate(DCR) assessed by BICR per RECIST v1.1 | Approximately 6 years | — |
| DCR assessed by investigator per RECIST v1.1 | Approximately 6 years | — |
| Duration of Response (DOR) assessed by BICR per RECIST v1.1 | Approximately 6 years | — |
| DOR assessed by investigator per RECIST v1.1 | Approximately 6 years | — |
| Number of participants with adverse event (AE) | Approximately 6 years | The number of participants experiencing an AE and the severity of AEs will be assessed. AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment. |
Countries
China
Contacts
CONTACTZhifang Yao, M.D.
Outcome results
None listed