Study of KN046 With Chemotherapy in First Line Advanced NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KN046 + carboplatin/paclitaxel

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

Group Type EXPERIMENTAL

KN046

Intervention Type BIOLOGICAL

IV infusion

Paclitaxel

Intervention Type DRUG

IV infusion

Carboplatin

Intervention Type DRUG

IV infusion

KN046 + carboplatin/pemetrexed

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

Group Type EXPERIMENTAL

KN046

Intervention Type BIOLOGICAL

IV infusion

Pemetrexed

Intervention Type DRUG

IV infusion

Carboplatin

Intervention Type DRUG

IV infusion

Interventions

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KN046

IV infusion

Intervention Type BIOLOGICAL

Paclitaxel

IV infusion

Intervention Type DRUG

Pemetrexed

IV infusion

Intervention Type DRUG

Carboplatin

IV infusion

Intervention Type DRUG

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No