SCLC, Extensive Stage Clinical Trial
Official title:
Phase Ib Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Etoposide and Carboplatin for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer
Verified date | May 2024 |
Source | Akeso |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Phase Ib open label, multicenter study to evaluate the efficacy and safety of anti-PD-1 and VEGF bispecific antibody (AK112) combined with chemotherapy in patients with ES-SCLC.
Status | Completed |
Enrollment | 35 |
Est. completion date | December 4, 2023 |
Est. primary completion date | December 4, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 18 to 75 years old (at the time of inform consent obtained). - Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). - Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group [VALG] staging system). - Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy. - Have a life expectancy of at least 3 months. - Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator - Has adequate organ function - All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment. Exclusion Criteria: - Undergone major surgery within 30 days prior to the first dose of study treatment - History of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer - Active central nervous system (CNS) metastases - History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). - Active infection requiring systemic therapy - Active Hepatitis B or Hepatitis C - History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment; - Pregnant or lactating women |
Country | Name | City | State |
---|---|---|---|
China | Shun Lu | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Akeso |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Grade 3 or higher adverse events (AEs) | Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0 | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years | |
Primary | Objective Response Rate (ORR) | ORR is proportion of subjects with complete response(CR) or partial response(PR). Tumor responses will be evaluated according to RECIST 1.1 criteria. Patients with no tumor assessment after baseline will be classified as non-responders. | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 18 months. | |
Secondary | Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for =8 weeks) based on RECIST V1.1 | Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years | |
Secondary | Progression free survival (PFS) | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first) | Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 24 months. | |
Secondary | Overall survival (OS) | OS is the time from the date of randomization or first dosing date to death due to any cause. | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 24 months. |
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