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Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Primary Purpose

Non-small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

KN046

Paclitaxel

Pemetrexed

Carboplatin

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

KN046 + carboplatin/paclitaxel

KN046 + carboplatin/pemetrexed

Arm 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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)

TEAE was defined any treatment emergent adverse event.

Number of Participants Who Experienced an immune-related AE (irAE)

irAE was defined any immune-related adverse event (AE).

Full Information

NCT ID

NCT04054531

First Posted

August 6, 2019

Last Updated

September 9, 2019

Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04054531

Brief Title

Study of KN046 With Chemotherapy in First Line Advanced NSCLC

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 4, 2019 (Actual)

Primary Completion Date

March 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Alphamab Biopharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

KN046 + carboplatin/paclitaxel

Arm Type

Experimental

Arm 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

Arm Title

KN046 + carboplatin/pemetrexed

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

KN046

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Pemetrexed

Intervention Description

IV infusion

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

IV infusion

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Description

Time Frame

Up to approximately 12 months

Title

Duration of Response (DOR) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Description

Time Frame

Up to approximately 12 months

Secondary Outcome Measure Information:

Title

Number of Participants Who Experienced a treatment-emergent adverse event (TEAE)

Description

TEAE was defined any treatment emergent adverse event.

Time Frame

Up to approximately 12 months

Title

Number of Participants Who Experienced an immune-related AE (irAE)

Description

irAE was defined any immune-related adverse event (AE).

Time Frame

Up to approximately 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yun Peng Yang, Doctor

Phone

020-87343822

yangyp@sysucc.org.cn

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

51000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yun peng Yang, Doctor

12. IPD Sharing Statement

Learn more about this trial

Study of KN046 With Chemotherapy in First Line Advanced NSCLC

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