NCT07459751
Not yet recruiting
Phase 2
A Randomized, Open-Label, Multi-center, Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 (Anti-PD-L1 ADC) Monotherapy or HLX43 in Combination With HLX07 (Recombinant Anti-EGFR Humanized Monoclonal Antibody Injection) Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
Shanghai Henlius Biotech1 site in 1 country671 target enrollmentStarted: April 9, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 671
- Locations
- 1
- Primary Endpoint
- Overall survival (OS)
Overview
Brief Summary
This is a randomized, open-label, multi-center, global phase II/III clinical study to evaluate the efficacy and safety of HLX43 monotherapy or HLX43 in combination with HLX07 vs. docetaxel in the treatment of advanced squamous NSCLC after failure of first-line treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have a full understanding of the study content, process, and possible adverse reactions before the study, and sign the informed consent form (ICF); voluntarily participate in the study; be able to complete the study as per protocol requirements;
- •Aged ≥ 18 years at the time of signing the ICF, male or female;
- •Histologically or cytologically confirmed squamous NSCLC, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) NSCLC not suitable for radical treatment (complete surgical resection, concurrent/sequential radio-chemotherapy) according to the Union for International Cancer Control and the American Joint Committee on Cancer (AJCC) TNM staging system (8th edition);
- •Subjects must have progressed after platinum-based chemotherapy in combination with anti-PD-1/anti-PD-L1 therapy as the only prior first-line treatment or progressed after platinum-based chemotherapy followed by anti-PD-1/anti-PD-L1 therapy (in any order) as the only prior second-line treatment.
- •Note: Definition of prior treatment failure with platinum-based chemotherapy:
- •Progressive disease following platinum-based chemotherapy in the recurrent or metastatic setting;
- •Progressive disease or recurrence during platinum-based chemotherapy, or within 6 months after the end of platinum-based chemotherapy in the neoadjuvant chemotherapy, concurrent radio-chemotherapy, or adjuvant chemotherapy setting;
- •Intolerance to platinum-based chemotherapy;
- •At least one measurable lesion as per RECIST v1.1 within 4 weeks prior to randomization; Note: Measurable target lesions should not be selected from previous radiotherapy sites or brain lesions. A measurable lesion within the field of local radiotherapy can be selected as the target lesion only when it is the only optional target lesion and the imaging evidence before and after progression should be available.
- •6\. Subjects who agree to provide archived tumor tissue specimens that meet the testing requirements (either from the most recent surgery or biopsy, preferably within 2 years) or agree to undergo a biopsy to collect tumor tissues for PD-L1 and EGFR expression testing; Note: Formalin-fixed paraffin-embedded (FFPE) tumor samples (paraffin blocks or unstained sections, which must meet the quality control criteria for testing) collected from non-radiotherapy sites during the most recent surgery or biopsy at or after the diagnosis of malignant tumor and pathological reports of such specimens shall also be provided.
Exclusion Criteria
- •Histologically or cytologically confirmed tumor containing components of small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma;
- •Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs;
- •Prior treatment with docetaxel;
- •Radical radiation therapy within 3 months prior to the first dose;
- •History of any second malignancy within 2 years prior to randomization, except for early-stage malignancies (carcinoma in situ or stage I tumors) that have received radical treatment, such as non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma;
- •History of ≥ Grade 3 irAEs in immunotherapy;
- •Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
- •Presence of spinal cord compression or clinically active metastases to central nervous system (referring to untreated or symptomatic metastases, or metastases requiring corticosteroids or anticonvulsants to control associated symptoms), carcinomatous meningitis. Subjects who have previously received treatment for brain metastases (such as whole brain radiotherapy or stereotactic brain radiotherapy) may be eligible, provided that they are clinically stable for at least 4 weeks with no imaging evidence of brain metastasis progression;
- •Subjects with current and prior history of clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to: any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, interstitial pneumonia, pneumoconiosis, and drug-related pneumonitis within 3 months prior to the first dose), any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, and sarcoidosis), prior pneumonectomy that may interfere with the detection and management of suspected drug-related pulmonary toxicity, or history of radiation pneumonitis within 6 months;
- •Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to:
Arms & Interventions
HLX43
Experimental
HLX43 intravenously on Day 1 of each 3-week cycle
Intervention: HLX43 (Drug)
HLX43 + HLX07
Experimental
HLX43 and HLX07 intravenously on Day 1 of each 3-week cycle;
Intervention: HLX43+HLX07 (Drug)
docetaxel
Active Comparator
Docetaxel intravenously on Day 1 of each 3-week cycle
Intervention: Docetaxel (Drug)
Outcomes
Primary Outcomes
Overall survival (OS)
Time Frame: approximately up to 24 months
PFS
Time Frame: approximately up to 24 months
assessed by the Blinded Independent Central Review \[BICR\]
Secondary Outcomes
- PFS(approximately up to 24 months)
- ORR(approximately up to 24 months)
- DOR(approximately up to 24 months)
- DCR(approximately up to 24 months)
- Incidence and severity of adverse events (AEs)(time from the date of the first dose of study drug until the date of death from any cause, assessed up to 24 months)
Investigators
Study Sites (1)
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