A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Henlius Biotech
About this trial
The study is to explore the the reasonable dosage and to evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in combination with Serplulimab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced lung cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1. Voluntarily to participate in the trial, and be able to complete the study as required by the protocol;
2. Age ≥18 years and ≤75 years;
3. Histologically or cytologically confirmed locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC unsuitable for radical treatment without actionable gene alteration (AGA); or Histologically or cytologically confirmed SCLC unsuitable for radical treatment, with evidence of disease progression or recurrence;
Have received platinum-based chemotherapy combined with anti-PD-1/L1 monoclonal or bispecific antibodies as prior first-line treatment; have received no more than second-line treatment; or
Disqualifiers
1. Mixed SCLC, mixed NSCLC, or sarcomatoid carcinoma components confirmed by tumor histology or cytology;
2. Imaging suggests tumor invasion of major blood vessels or important organs, or the presence of a risk of esophago-tracheal fistula or esophagopleural fistula;
3. Previously received any drug therapy targeting topoisomerase I, including chemotherapy or ADC drugs;
4. Received radical radiotherapy within 3 months prior to the first dose;
Trial design
Design model
Parallel
Treatments tested in this trial
HLX43 dose 1
DrugHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
HLX43 dose 2
DrugHLX43 is an anti-PD-L1 monoclonal antibody conjugated with a novel high potency DNA topoisomerase I (topo I) inhibitor, with a drug-antibody-ratio (DAR) of 8.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: HLX43 dose 1Experimental treatment 1 intervention
Group B: HLX43 dose 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
ORR
Objective response rate (ORR) is the proportion of subjects with the best overall response being CR or PR (assessed by investigator per RECIST v1.1)
Time frame
up to 24 weekSecondary outcomes
1
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by investigator per RECIST v1.1.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months2
ORR
ORR is the proportion of subjects with the best overall response being CR or PR (assessed by IRRC per RECIST v1.1)
Time frame
Up to 24 weeks3
PFS
Defined as the time (in months) from randomization to the first confirmed and documented progressive disease or death (whichever occurs first) as assessed by the IRRC per RECIST v1.1.
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months4
OS
Overall Survival
Time frame
From randomization to death from any cause (up to approximately 18 months)Sponsors and contacts
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Source ClinicalTrials.gov