Back to resultsA Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
Primary Purpose
Squamous Non-small-cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
HLX10+chemo
HLX10+HLX07+chemo
HLX10+HLX07
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Non-small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
- EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
- Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
- Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has a life expectancy of greater than 12 weeks
- Has adequate organ function
Exclusion Criteria:
- Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
- Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
- EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
- Has had other active malignancies within 5 years or at the same time
- Has uncontrolled pleural effusion、pericardial effusion or ascites
Sites / Locations
- Guangdong Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
A arm: HLX10+chemo
B arm: HLX10+HLX07+chemo
C arm: HLX10+HLX07
Arm Description
Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle.
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Secondary Outcome Measures
Adverse Events (AE)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Duration of Response (DOR) per RECIST 1.1 assessed by IRRC
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04976647
Brief Title
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
Official Title
A Randomized, Open-Label, Multicenter, Phase II Study of HLX07 (Anti-EGFR Antibody) +HLX10 (Anti-PD-1 Antibody) With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical efficacy and safety of HLX07 In Combination with HLX10 with or without Chemotherapy versus HLX10 with Chemotherapy in First Line Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer.This study consists of three periods, screening period (28 days), treatment period and follow-up period (including safety follow-up, survival follow-up).Subjects can be enrolled into this study only if they meet inclusion criteria and do not meet exclusion criteria.
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A arm: HLX10+chemo
Arm Type
Active Comparator
Arm Description
Participants receive 300mg HLX10 IV every 3 weeks (Q3W) in combination with carboplaitin (AUC5 or 6) IV Q3W and nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle.
Arm Title
B arm: HLX10+HLX07+chemo
Arm Type
Experimental
Arm Description
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
Arm Title
C arm: HLX10+HLX07
Arm Type
Experimental
Arm Description
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.
Intervention Type
Drug
Intervention Name(s)
HLX10+chemo
Intervention Description
HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Intervention Type
Drug
Intervention Name(s)
HLX10+HLX07+chemo
Intervention Description
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Intervention Type
Drug
Intervention Name(s)
HLX10+HLX07
Intervention Description
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC
Description
ORR is defined as the percentage of participants who have a Complete Response ([CR], disappearance of all evidence of disease) or Partial Response ([PR], regression of measurable disease and no new sites) per RECIST 1.1 as assessed by IRRC. ORR will be determined for each treatment arm.
Time Frame
Up to 5 years
Title
Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
Description
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 as assessed by IRRC or death due to any cause, whichever occurs first. PFS will be determined for each treatment arm
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Adverse Events (AE)
Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. The number of participants who experience an AE will be reported for each treatment arm.
Time Frame
Up to 5 years
Title
Duration of Response (DOR) per RECIST 1.1 assessed by IRRC
Description
For participants who demonstrate CR or PR, DOR is defined as the time from first response (CR or PR) to subsequent disease progression or death from any cause, whichever occurs first. DOR will be determined for each treatment arm
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed diagnosis of previously untreated, Recurrent or Metastatic Squamous Non-Small Cell Lung Cancer
EGFR immunohistochemistry (IHC) H score ≥200 assessed by central lab
Has measurable disease as defined by RECIST 1.1 as determined by the IRRC
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Has a life expectancy of greater than 12 weeks
Has adequate organ function
Exclusion Criteria:
Histologically non-squamous NSCLC must be exclused. For non-small-cell histology, if has squamous components be allowed
Has history of such as PD-1/PD-L1、EGFR、 CTLA4 targeted therapy
EGFR sensitivity mutation or ALK or ROS1 gene rearrangement need to be excluded
Has had other active malignancies within 5 years or at the same time
Has uncontrolled pleural effusion、pericardial effusion or ascites
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wu yilong, phD
Phone
(8620)83827812-51486
Email
syylwu@live.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC
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