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
Qualifiers
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
Treatments tested in this trial
- HLX43 dose 1
- HLX43 dose 2
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov