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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Squamous Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: HLX10+chemo
* Drug: HLX10+HLX07+chemo
* Drug: HLX10+HLX07


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A arm: HLX10+chemo<br>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<br>* HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle<br>|
| Experimental: B arm: HLX10+HLX07+chemo<br>Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo. | Drug: HLX10+HLX07+chemo<br>* HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle<br>|
| Experimental: C arm: HLX10+HLX07<br>Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W. | Drug: HLX10+HLX07<br>* HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years | 
| 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 | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 5 years | 
| 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 | Up to 5 years | 
| 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. | Up to 5 years |