Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Alphamab

Status and phase: Unknown; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Pemetrexed; Biological: KN046; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04054531

KN046-202

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

KN046 + carboplatin/paclitaxel

Experimental group

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

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Biological: KN046

KN046 + carboplatin/pemetrexed

Experimental group

Description:

KN046 5 mg/kg IV Q3W +Carboplatin AUC5 IV Q3W x 4 cycles + Pemetrexed 500 mg/m2 IV Q3W x 4 cycles

Treatment:

Drug: Carboplatin

Drug: Pemetrexed

Biological: KN046