Study of KN046 With Chemotherapy in First Line Advanced NSCLC
An Open-label, Phase II Study of KN046 Evaluating the Efficacy and Safety of KN046 Plus Platinum-based Doublet Chemotherapy as First Line Therapy in Advanced Non-small Cell Lung Cancer Subjects.
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 nonsmall-cell-lung-cancer
Started Sep 2019
Shorter than P25 for phase_2 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2019
CompletedFirst Posted
Study publicly available on registry
August 13, 2019
CompletedStudy Start
First participant enrolled
September 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedSeptember 10, 2019
August 1, 2019
1.5 years
August 6, 2019
September 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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.
Up to approximately 12 months
Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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.
Up to approximately 12 months
Secondary Outcomes (2)
Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)
Up to approximately 12 months
Number of Participants Who Experienced an immune-related AE (irAE)
Up to approximately 12 months
Study Arms (2)
KN046 + carboplatin/paclitaxel
EXPERIMENTALKN046 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
EXPERIMENTALKN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 51000, China
Related Publications (1)
Zhao Y, Chen G, Li X, Wu J, Chang B, Hu S, Yang S, Xu T, Liu Y, Wang N, Zhang L, Huang Y. KN046, a bispecific antibody against PD-L1 and CTLA-4, plus chemotherapy as first-line treatment for metastatic NSCLC: A multicenter phase 2 trial. Cell Rep Med. 2024 Mar 19;5(3):101470. doi: 10.1016/j.xcrm.2024.101470.
PMID: 38508135DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2019
First Posted
August 13, 2019
Study Start
September 4, 2019
Primary Completion
March 1, 2021
Study Completion
June 1, 2021
Last Updated
September 10, 2019
Record last verified: 2019-08