Study of KN046 With Chemotherapy in First Line Advanced NSCLC
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT04054531
- Lead Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Brief Summary
This is a phase II study of KN046 plus platinum-based doublet chemotherapy in previously untreated advanced non-squamous and squamous NSCLC subjects.
The study will assess primarily the safety and efficacy of KN046 plus platinum-based doublet chemotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- Has a histologically or cytologically confirmed diagnosis of stage IV NSCLC;
- Has not received prior systemic treatment for metastatic NSCLC;
- Has measurable disease based on RECIST 1.1.
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
- Has adequate organ function.
- Has provided tumor tissue from locations not radiated prior to biopsy.
Key
- Previous immunotherapy (e.g. anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways)
- Previously untreated or symptomatic central nervous system (CNS) metastases
- Has received a live-virus vaccination within 28 days of planned treatment start.
- Previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody and chemotherapy.
- Has or had active autoimmune disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KN046 + carboplatin/paclitaxel KN046 KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles KN046 + carboplatin/pemetrexed Pemetrexed KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles KN046 + carboplatin/pemetrexed Carboplatin KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles KN046 + carboplatin/pemetrexed KN046 KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles KN046 + carboplatin/paclitaxel Paclitaxel KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles KN046 + carboplatin/paclitaxel Carboplatin KN046 5 mg/kg IV every three weeks (Q3W) +Carboplatin AUC5 IV Q3W x 4 cycles + Paclitaxel 500 mg/m2 IV Q3W x 4 cycles
- Primary Outcome Measures
Name Time Method Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Up to approximately 12 months For participants who demonstrated a confirmed response (Complete Response \[CR\]: Disappearance of all target lesions or Partial Response \[PR\]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression as assessed by RECIST 1.1 or death.
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Up to approximately 12 months ORR was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by RECIST 1.1. ORR.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experienced a treatment-emergent adverse event (TEAE) Up to approximately 12 months TEAE was defined any treatment emergent adverse event.
Number of Participants Who Experienced an immune-related AE (irAE) Up to approximately 12 months irAE was defined any immune-related adverse event (AE).
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China