Status and phase
Conditions
Treatments
About
Phase: 3 Type: Randomized, open-label, multi-regional, multi-center Population: Adults with advanced/metastatic squamous Non Small Cell Lung Cancer (NSCLC), post-progression on platinum chemo + PD-1/PD-L1 immunotherapy Enrollment: ~600 participants Randomization: 1:1 (IBI363 vs. docetaxel)
Stratification factors:
Treatment Arms:
IBI363 Arm (Investigational Drug):
Priming dose: 0.1 mg/kg on Day 1 of Cycle 1 (C1D1) Intended dose: 3 mg/kg every 3 weeks (Q3W) starting Day 8 of Cycle 1 (C1D8) Cycle duration: 28 days for Cycle 1, then 21 days from Cycle 2 onward Dose adjustments: Up to 2 reductions (1.5 mg/kg or 1 mg/kg Q3W) allowed for adverse events (AEs) Re-priming protocol: Required if delays in dosing exceed defined thresholds (e.g., >10 days post-priming or ≥5 weeks since last dose)
Control Arm (Docetaxel):
75 mg/m² every 3 weeks (Q3W), starting from C1D1 21-day cycle duration Dose Reduction: as per label
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of any study drug. WOCBP or fertile men with WOCBP partner(s), not using and/or not willing to use a highly effective method of contraception.
Known actionable genomic alteration, including any of the following driver gene mutations:
Note: It is not mandatory to have undergone driver gene testing.
Active or symptomatic brain metastases. Participants who are clinically and radiologically stable at least 4 weeks after treatment and participants with small, asymptomatic, incidental, untreated brain metastases that remain stable ≥ 4 weeks may participate in this study as long as they meet all of the following criteria:
Presence of any of the following hematologic abnormalities at Baseline*:
Presence of any of the following serum chemistry abnormalities at Baseline:
Presence of any of the following coagulation parameter abnormalities at Baseline:
History of deep venous thrombosis, pulmonary embolism, or any other serious thromboembolic events within 3 months prior to enrollment (implantable port or catheter-related thrombosis, or superficial venous thrombosis are not considered ""serious"" thromboembolisms); portal vein tumor thrombus involving both the main trunk and bilateral first-order branches, or involving both the main trunk and superior mesenteric vein, or inferior vena cava tumor thrombus.
Active uncontrolled bleeding or known bleeding tendency. For example, imaging shows that the tumor invades large blood vessels or has unclear boundaries (including aorta, pulmonary aorta, left pulmonary artery, right pulmonary artery, pulmonary vein, superior vena cava, inferior vena cava, etc.), or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the subsequent study.
Presence of clinically significant cardiovascular or cerebrovascular diseases, including:
Cardiac enzymes ≥ levels consistent with myocardial infarction as defined by the manufacturer (i.e., Grade 3).
History of the following lung diseases requiring steroid therapy: interstitial lung disease (ILD), pulmonary fibrosis, drug-related and radiation pneumonitis; current active pulmonary infection requiring anti-infective therapy; active pulmonary tuberculosis within 1 year prior to enrollment; severely impaired pulmonary function, including but not limited to the following: pulmonary embolism, severe asthma or chronic obstructive pulmonary disease within 3 months prior to randomization; autoimmune, connective tissue, or inflammatory diseases involving the lungs (such as rheumatoid arthritis, Sjögren's disease, and sarcoidosis); previous unilateral pneumonectomy.
History of severe, poorly controlled allergies, asthma or atopic dermatitis (except for atopic dermatitis caused by immunotherapy). Note: remote history of childhood asthma is not exclusionary.
History of anaphylactic or hypersensitivity reactions. Uncontrolled third space effusion requiring repeated drainage, such as pleural effusion, abdominal effusion, pericardial effusion, etc.
Note: Participants with the following conditions may be enrolled:
Current or recent (within 6 months) significant gastrointestinal disease or condition, including:
Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose.
Note: Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments and exclusionary.
Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
Known or suspected allergy to the investigational medical product and any excipients. Known or suspected severe hypersensitivity reactions to docetaxel or to drugs formulated with polysorbate 80.
Prior history of significant toxicity related to immune checkpoint inhibitor administration that required permanent discontinuation of this therapy.
Unresolved Grade > 1 toxicity related to any previous anti-tumor therapy (excluding alopecia, asthenia, hypothyroidism requiring only thyroid hormone replacement therapy, hyperglycemia requiring only insulin replacement therapy, adrenal insufficiency requiring physiological steroid replacement, electrolyte abnormalities requiring only symptomatic treatment, and other conditions not affecting the investigational medical product treatment as assessed by the investigator).
Have not adequately recovered from previous surgery or have undergone any major surgery, such as carotid artery stenting or esophageal stenting, within 4 weeks before the first dose of investigational medical product.
Uncontrolled tumor-related pain or symptomatic hypercalcemia.
Uncontrolled human immunodeficiency virus (HIV), active syphilis, active hepatitis B (HBV), hepatitis C (HCV), or tuberculosis.
Serious/active/uncontrolled infection, infection requiring systemic intravenous antibiotics, or fever of unknown origin (≥ 38°C) within 2 weeks before the first dose of investigational medical product(s).
History or current evidence of any disease, treatment, or laboratory abnormality that, in the judgment of the investigator, could compromise the safety of the participant, interfere with obtaining informed consent, affect participant compliance, or affect safety evaluations of the investigational medical product.
Psychiatric illness, altered mental status, or drug abuse that prevents understanding of the informed consent process and/or completion of required study-related evaluations.
Unable to meet protocol requirements for known or foreseeable reasons per investigator judgement.
Diagnosed with other pathologically confirmed malignancies within 5 years prior to informed consent, with the exception of radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ, localized prostate cancer, papillary thyroid cancer, and other radically treated malignancies with no known active disease for at least 2 years prior to enrollment and with a very low risk of recurrence.
Received any of the following excluded medications or treatments:
Primary purpose
Allocation
Interventional model
Masking
600 participants in 2 patient groups
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Central trial contact
Farah Dahman, MPA
Data sourced from clinicaltrials.gov
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