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A Study of HLX07 + HLX10 With or Without Chemotherapy Versus HLX10 With Chemotherapy in First Line sqNSCLC

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ClinicalTrials.gov Identifier: NCT04976647
Recruitment Status : Recruiting
First Posted : July 26, 2021
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Non-small-cell Lung Cancer Drug: HLX10+chemo Drug: HLX10+HLX07+chemo Drug: HLX10+HLX07 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 18, 2022
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A arm: HLX10+chemo
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.
 Drug: HLX10+chemo
HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Experimental: B arm: HLX10+HLX07+chemo
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
 Drug: HLX10+HLX07+chemo
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Experimental: C arm: HLX10+HLX07
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.
 Drug: HLX10+HLX07
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC [ Time Frame: Up to 5 years ]
    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.

  2. Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) [ Time Frame: Up to 5 years ]
    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 :
  1. Adverse Events (AE) [ Time Frame: Up to 5 years ]
    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.

  2. Duration of Response (DOR) per RECIST 1.1 assessed by IRRC [ Time Frame: Up to 5 years ]
    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

  3. Overall Survival (OS) [ Time Frame: Up to 5 years ]
    OS is defined as the time from randomization to death due to any cause. OS will be determined for each treatment arm.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04976647


Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wu yilong, phD    (8620)83827812-51486    syylwu@live.cn   
Sponsors and Collaborators
Shanghai Henlius Biotech
More Information
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT04976647    
Other Study ID Numbers: HLX10HLX07-sqNSCLC-201
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases