Actively Recruiting
A Randomized, Open-Label, Multi-center, Global Phase II/III Study to Evaluate HLX43 Alone or With HLX07 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Led by Shanghai Henlius Biotech · Updated on 2026-06-01
706
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized, open-label, multi-center, global phase II/III clinical trial to evaluate the safety and effectiveness of HLX43 alone or combined with HLX07 compared to docetaxel in treating advanced or metastatic squamous non-small cell lung cancer (NSCLC) after first-line treatment failure. This study focuses on patients with locally advanced or metastatic squamous NSCLC who have progressed after prior platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. Participants are assigned to one of three groups receiving intravenous treatments on Day 1 of each 3-week cycle: HLX43 monotherapy, HLX43 combined with HLX07, or docetaxel as an active comparator. The study includes treatment periods with these regimens, assessing their impact over time. The trial is sponsored by Shanghai Henlius Biotech and spans multiple global centers. Throughout the study, participants undergo regular evaluations including survival assessments up to 24 months, monitoring progression-free survival, tumor response rates, duration of response, disease control rates, and adverse events. Laboratory tests, imaging, and tumor tissue analyses for PD-L1 and EGFR expression are conducted. Participants are monitored for safety and treatment adherence, with an expected life expectancy of more than three months and an ECOG performance status of 0-1 at enrollment.
CONDITIONS
Brief Title
A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily agree to participate by signing consent
- Age 18 years or older, male or female
- Confirmed locally advanced or metastatic squamous NSCLC not suitable for radical treatment
- Progressed after platinum-based chemotherapy combined with anti-PD-1/PD-L1 therapy as first- or second-line treatment
- Have at least one measurable lesion not from prior radiotherapy or brain lesions
- Agree to provide tumor tissue samples for PD-L1 and EGFR testing
- Meet timing requirements for prior treatments and have recovered from related adverse events
- ECOG performance status of 0-1 within one week before randomization
- Life expectancy greater than 3 months
- Adequate organ function confirmed by recent lab tests
- Agree to use effective contraception during and for 6 months after the study; negative pregnancy test for females of childbearing potential
You will not qualify if you...
- Tumors containing small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components
- Previous treatment with topoisomerase I targeting drugs or docetaxel
- Radical radiation therapy within 3 months before first study dose
- History of second malignancy within 2 years, except certain early-stage cancers
- History of severe immune-related adverse events from immunotherapy
- Uncontrollable pleural, pericardial effusion, or ascites needing repeated drainage
- Active or symptomatic brain metastases or spinal cord compression
- Significant pulmonary diseases or history affecting lung function
- Poorly controlled cardiovascular or cerebrovascular diseases
- Active systemic infections requiring IV antibiotics
- Recent use of certain enzyme inhibitors or immunosuppressants
- Known active or suspected autoimmune diseases (with some exceptions)
- Recent live or live attenuated vaccine
- Known allergy to study drugs or components
- Active tuberculosis or immunodeficiency conditions including HIV
- Active hepatitis B or C infection not meeting viral load criteria
- Pregnancy or breastfeeding
- Other clinical or laboratory issues deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive HLX43 alone or in combination with HLX07, or docetaxel, administered intravenously on Day 1 of each 3-week cycle.
Visits every 3 weeks for treatment administration
Duration - Up to approximately 24 months
Participants are monitored for overall survival, progression-free survival, and safety outcomes after treatment ends.
Periodic visits as scheduled by the study team
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
Jie Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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