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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A arm: HLX10+chemo | Active Comparator | 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. |
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| B arm: HLX10+HLX07+chemo | Experimental | Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo. |
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| C arm: HLX10+HLX07 | Experimental | Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10+chemo | Drug | HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| HLX10+HLX07+chemo | Drug | HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle |
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| HLX10+HLX07 | Drug | HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; |
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| 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 |