Non-small Cell Lung Cancer
Conditions
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.
Interventions
BIOLOGICALKN046
IV infusion
DRUGPaclitaxel
IV infusion
DRUGPemetrexed
IV infusion
DRUGCarboplatin
IV infusion
Sponsors
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactYun Peng Yang, Doctor
Outcome results
None listed