Clinical trial · Interventional
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.
NCT04054531CI-TRIAL-00040499unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| KN046 | Biological | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- KN046 + carboplatin/paclitaxel
- description
- 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
- interventionNames
- Biological: KN046
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- KN046 + carboplatin/pemetrexed
- description
- KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles
- interventionNames
- Biological: KN046
- Drug: Pemetrexed
- Drug: Carboplatin
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDZhao 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 38508135