Previously Treated Advanced or Metastatic Squamous Non-Small Cell Lung
Conditions
Interventions
Drug: HLX43
Drug: HLX43+HLX07
Drug: Docetaxel
Sponsors
Asato Takayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.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; 2.Aged >= 18 years at the time of signing the ICF, male or female; 3.Histologically or cytologically confirmed squamous NSCLC, locally advanced (stage IIIB/IIIC) or metastatic (stage IV) squamous 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); 4.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: 1)Progressive disease following platinum-based chemotherapy in the recurrent or metastatic setting; 2)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; 3)Intolerance to platinum-based chemotherapy 5.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. 7.The following conditions must be met in terms of the time of the first administration of the investigational product: at least 3 weeks (or 5 half-lives of the drug, whichever is shorter) from the previous major surgery, medical device treatment, locoregional radiotherapy (except for palliative radiotherapy for bone lesions), cytotoxic chemotherapy, or immunotherapy; at least 1 week from the administration of the traditional Chinese medicine for anti-cancer indications or minor surgery; and recovery of treatment-induced AEs to Grade 3 months; 10.Adequate organ functions as confirmed by laboratory tests within 1 week prior to randomization (no blood transfusions or treatment with granulocyte colony-stimulating factor within 14 days prior to the first dose): 11.Male and female subjects with child-bearing potential must agree to use at least one
Exclusion criteria
Exclusion criteria: 1.Histologically or cytologically confirmed tumor containing components of small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma; 2.Prior treatment with any medication targeting topoisomerase I, including chemotherapy or ADCs; 3.Prior treatment with docetaxel; 4.Radical radiation therapy within 3 months prior to the first dose; 5.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; 6.History of >= Grade 3 irAEs in immunotherapy; 7.Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 8.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; 9.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; 10.Patients with any poorly-controlled cardiovascular and cerebrovascular clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or greater heart failure or left ventricular ejection fraction (LVEF) = 470 ms) (QTc interval is calculated by Fridericia's formula); (5) poorly-controlled hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg after active treatment); 11.Patients with active systemic infectious diseases requiring intravenous antibiotics within 2 weeks prior to randomization; 12.Patients who have used moderate or potent CYP2D6 or CYP3A inhibitors or inducers within 2 weeks prior to randomization; 13.Patients who have received systemic corticosteroids (prednisone > 10 mg/d or equivalent dose of similar drug) or other immunosuppressants within 2 weeks prior to randomization; Except: patients treated with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term prophylactic use of corticosteroids for contrast agents, etc.; 14.Patients with known active or suspected autoimmune diseases. Patients with autoimm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall survival (OS) - Progression-free survival (PFS) (assessed by the Blinded Independent Central Review [BICR] ) | — |
Countries
China, Japan, USA
Contacts
Public ContactTakayuki Asato
Fosun Henlius Pharmaceutical K.K.
Outcome results
None listed