KN046 Plus Lenvatinib in Subject With Advanced Non-Small Cell Lung Cancer in the Failure of Anti-PD-(L)1 Agent
- Conditions
- Advanced Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05001724
- Lead Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Brief Summary
This is a phase 2/3, multicenter, randomized, open, positive-controlled study of patients with advanced non-small cell lung cancer whose disease has progressed after prior anti-PD-(L)1 therapy. Subjects should have documented progressive disease during prior treatment with first- or second-line PD-(L)1 and platinum-containing dual-agent chemotherapy.Subjects will be randomized to two treatment groups in a 1:1 ratio.
Treatment Group: KN046 5mg/kg Q3W + lenvatinib recommended for phase III dose (RP3D) every day.
Control group: Docetaxel 75mg/m2 Q3W .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 16
Not provided
- Untreated active central nervous system metastasis or leptomeningeal metastasis;
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines;
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
- History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent;
- Previous malignant disease;
- History of uncontrolled intercurrent illness;
- Prior therapy with any antibody/drug targeting T cell coregulatory proteins;
- Has received treatment with lenvatinib or docetaxel or VEGFR-TKI;
- Known severe hypersensitivity reactions to antibody drug;
- Is pregnant or breastfeeding;
- Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: KN046 plus Lenvatinib RP3D. Lenvatinib Experimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity. Cohort 1: KN046 plus Lenvatinib RP3D. KN046 Experimental arm: Cohort 1: KN046 5mg/kg every 3 weeks + lenvatinib RP3D every day until progressive disease or unacceptable toxicity. Docetaxel Docetaxel Active Comparator: docetaxel 75 mg/m² every 3 weeks until progressive disease or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method DLT 28 days or 21 days Dose limit toxicity (phase 2)
OS up to 2 years Overall survival (OS) was defined as the time from randomization to death due to any cause (phase 3).
PFS up to 2 years Progression-free survival (PFS) was defined as the time from randomization grouping to the first documented disease progression or death from any cause as evaluated by the investigator according to RECIST 1.1 criteria (phase 3).
- Secondary Outcome Measures
Name Time Method ORR up to 2 years Objective response rate (ORR) based on the RECIST 1.1 by principal investigator
DCR up to 2 years Disease control rate (DCR) based on the RECIST 1.1 by principal investigator
DOR up to 2 years Duration of response (DOR) based on the RECIST 1.1 by principal investigator
CBR up to 2 years Clinical benefit rate (CBR) based on the RECIST 1.1 by independent review committee
TTR up to 2 years Time to response (TTR) based on the RECIST 1.1 by independent review committee
Trial Locations
- Locations (1)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, Shanghai, China