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KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

Primary Purpose

Squamous Non-small-cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
KN046
KN046 placebo
Sponsored by
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV squamous NSCLC.
  • No known epidermal growth factor receptor (EGFR) mutations.
  • Has measurable disease.
  • Has not received prior systemic treatment for their advanced/metastatic NSCLC.
  • Can provide tumor tissue.
  • Has a life expectancy of at least 3 months.
  • Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
  • Has adequate organ function
  • If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
  • If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment.

Exclusion Criteria:

  • Untreated active CNS metastasis or leptomeningeal metastasis.
  • Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment;
  • Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment;
  • Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
  • Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
  • Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
  • Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
  • Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
  • History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Previous malignant disease
  • History of uncontrolled intercurrent illness
  • Prior therapy with any antibody/drug targeting T cell coregulatory proteins
  • Known severe hypersensitivity reactions to antibody drug
  • Is pregnant or breastfeeding;
  • Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.

Sites / Locations

  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental arm

Control arm

Arm Description

KN046 plus Carboplatin and Paclitaxel

Placebo plus Carboplatin and Paclitaxel

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.

Secondary Outcome Measures

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

Full Information

First Posted
July 13, 2020
Last Updated
November 16, 2021
Sponsor
Jiangsu Alphamab Biopharmaceuticals Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04474119
Brief Title
KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase III Study to Assess the Efficacy and Safety of KN046 Combined With Platinum-containing Chemotherapy Versus Placebo Combined With Platinum-containing Chemotherapy in First Line Advanced Squamous Non-small Cell Lung Cancer Subjects (ENREACH-L-01)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
August 30, 2023 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of KN046 plus paclitaxel and carboplatin versus placebo plus paclitaxel and carboplatin in subjects with advanced squamous NSCLC who have not previously received systemic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Non-small-cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
482 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
KN046 plus Carboplatin and Paclitaxel
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Placebo plus Carboplatin and Paclitaxel
Intervention Type
Drug
Intervention Name(s)
KN046
Intervention Description
In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
Intervention Type
Drug
Intervention Name(s)
KN046 placebo
Intervention Description
In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Central Imaging
Description
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time Frame
up to 2 years
Title
Overall Survival (OS)
Description
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the interim analysis were censored at the date of the last follow-up.
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Investigators
Description
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Time Frame
up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV squamous NSCLC. No known epidermal growth factor receptor (EGFR) mutations. Has measurable disease. Has not received prior systemic treatment for their advanced/metastatic NSCLC. Can provide tumor tissue. Has a life expectancy of at least 3 months. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status. Has adequate organ function If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment; If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment. Exclusion Criteria: Untreated active CNS metastasis or leptomeningeal metastasis. Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first dose of trial treatment; Has received other anti-tumor treatment within 4 weeks or within 5 times of half-life (no less than 2 weeks), whichever is shorter prior to the first trial treatment; Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment; Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment; Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids); Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines); Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management; History or current active autoimmune disease that might deteriorate when receiving an immunostimulatory agent Previous malignant disease History of uncontrolled intercurrent illness Prior therapy with any antibody/drug targeting T cell coregulatory proteins Known severe hypersensitivity reactions to antibody drug Is pregnant or breastfeeding; Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, MD, PhD
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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KN046 in Subjects With Advanced Squamous Non-small Cell Lung Cancer

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