A Phase 2 interventional study of HLX10+chemo and HLX10+HLX07+chemo in Squamous Non-small-cell Lung Cancer, sponsored by Shanghai Henlius Biotech. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Shanghai Henlius Biotech (part of Fosun Pharma) · Phase 2, Interventional, and Treatment
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.
Shanghai Henlius Biotech is the lead sponsor of 131 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W with chemo.
Drug: HLX10+HLX07+chemo
Participants receive 300mg HLX10 IV Q3W plus 1500mg HLX07 IV Q3W.
Drug: HLX10+HLX07
Drug page: Serplulimab
HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Drug pages: Serplulimab · HLX07
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
Drug pages: Serplulimab · HLX07
HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;
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.
Time frame: 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
Time frame: Up to 5 years
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.
Time frame: 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
Time frame: 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.
Time frame: Up to 5 years
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Serplulimab · HLX07