Squamous Non-small-cell Lung Cancer
Conditions
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.
Interventions
DRUGHLX10+chemo
HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
DRUGHLX10+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
DRUGHLX10+HLX07
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;
Sponsors
Shanghai Henlius Biotech
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per RECIST 1.1 assessed by IRRC | 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. |
| Progression Free Survival (PFS) per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee) | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AE) | 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. |
| Duration of Response (DOR) per RECIST 1.1 assessed by IRRC | 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 |
| Overall Survival (OS) | 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. |
Countries
China
Outcome results
None listed