Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Non-small Cell Lung Cancer Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04054531
• Other study ID #: KN046-202
• Status: Recruiting
• Phase: Phase 2
• Start date: September 4, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: August 2019
• Source: Jiangsu Alphamab Biopharmaceuticals Co., Ltd
• Contact: Yun Peng Yang, Doctor
• Phone: 020-87343822
• Email: yangyp[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Biological:
• KN046
IV infusion

Drug:
• Paclitaxel
IV infusion
• Pemetrexed
IV infusion
• Carboplatin
IV infusion

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Alphamab Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)	TEAE was defined any treatment emergent adverse event.	Up to approximately 12 months
Secondary	Number of Participants Who Experienced an immune-related AE (irAE)	irAE was defined any immune-related adverse event (AE).	Up to approximately 12 months