Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06907615

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Led by Shanghai Henlius Biotech · Updated on 2025-08-17

243

Participants Needed

2

Research Sites

155 weeks

Total Duration

On this page

Sponsors

S

Shanghai Henlius Biotech

Lead Sponsor

H

Henlius USA Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The study is being conducted to to explore the reasonable dosage and evaluate the efficacy, safety and tolerability of HLX43 (Anti-PD-L1 ADC) in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

CONDITIONS

Official Title

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Advanced Non-small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand the study and provide signed informed consent
  • Aged 18 years or older
  • Diagnosed with locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC not suitable for curative treatment
  • For non-squamous NSCLC without actionable genomic alterations, documented negative tests for EGFR and ALK or tested at study site
  • For squamous NSCLC, EGFR and ALK testing not required if unknown
  • No other known actionable genomic alterations such as ROS1, NTRK, BRAF, MET exon 14 skipping, or RET
  • Prior failure of at least one standard treatment line including anti-PD-(L)1 antibody and platinum chemotherapy; or for patients with actionable alterations, prior targeted therapy and platinum chemotherapy
  • At least one measurable tumor lesion per RECIST 1.1 within 4 weeks before randomization
  • Agree to provide archived or new tumor tissue for PD-L1 testing
  • At least 3 weeks from prior major surgery, radiotherapy (except palliative for bone), chemotherapy, immunotherapy or biological therapy, with recovery of treatment-related adverse events to Grade 1 or less
  • ECOG performance status 0-1 within 1 week before randomization
  • Life expectancy greater than 3 months
  • Adequate organ function based on lab tests within 1 week before randomization
  • Agree to use effective contraception during study and 6 months after last dose (if of childbearing potential)
  • Negative pregnancy test within 7 days before enrollment (if female of childbearing age)
Not Eligible

You will not qualify if you...

  • Tumors containing small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components
  • Prior treatment with any topoisomerase I targeting drugs including chemotherapy or ADCs
  • Radical radiation therapy within 3 months before first dose
  • Second malignancy within 2 years except certain early-stage cancers treated radically
  • History of severe immune-related side effects or pneumonitis/myocarditis of grade 2 or higher from prior immunotherapy
  • Uncontrolled pleural, pericardial effusion, or ascites needing repeated drainage
  • Spinal cord compression or active brain metastases requiring corticosteroids or anticonvulsants; stable treated brain metastases allowed
  • Significant lung diseases or pulmonary impairments including recent pulmonary embolism, severe asthma, COPD, restrictive lung disease, interstitial pneumonia, pneumoconiosis, drug-related pneumonitis, or recent pleural effusion
  • Poorly controlled heart disease including heart failure (NYHA class II or higher), low ejection fraction, unstable angina, recent heart attack or stroke, uncontrolled arrhythmias, or hypertension
  • Active infections requiring IV antibiotics
  • Use of moderate or strong CYP2D6 or CYP3A inhibitors/inducers within 2 weeks before randomization
  • Recent systemic corticosteroids or immunosuppressants within 2 weeks before randomization except certain topical or short-term uses
  • Known active or suspected autoimmune diseases except controlled hypothyroidism or type 1 diabetes
  • Recent live vaccine within 4 weeks before randomization
  • Known allergy to macromolecular protein drugs or study drug components
  • Active tuberculosis
  • History of immunodeficiency including HIV or organ transplant
  • Active hepatitis B or C infections
  • Pregnant or breastfeeding
  • Any clinical or lab abnormalities or other reasons making participation unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

MD Anderson Cancer Hospital

Houston, Texas, United States, 77030

Not Yet Recruiting

2

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

J

Jie He, Dr

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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