IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have… (NCT07217301) | Clinical Trial Compass
RecruitingPhase 3
IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed
United States600 participantsStarted 2025-11-26
Plain-language summary
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:
1. Primary vs. acquired IO resistance
2. Concurrent vs. sequential prior chemo-immunotherapy
3. Region (Asia vs. non-Asia)
Treatment Arms:
1. 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)
2. Control Arm (Docetaxel):
75 mg/m² every 3 weeks (Q3W), starting from C1D1 21-day cycle duration Dose Reduction: as per label
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Willing to sign the written informed consent form and be able to comply with the visit schedule and related procedures specified in the protocol.
✓. Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater.
✓. Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC Note: Mixed small cell carcinoma, or other pathological components are excluded.
✓. Resistant or refractory to systemic anti-tumor therapy, including platinum-based doublet chemotherapy and primary or secondary resistance to anti-PD-1/PD-L1 monoclonal antibody given in combination or sequentially; or given as neoadjuvant and/or adjuvant therapy, which will be considered first-line treatment if the disease has recurred or progressed during such treatment or within 6 months after discontinuation.
✓. Radiographic progression per RECIST v1.1 during or within 6 months after discontinuation of anti-PD-1/PD-L1 monoclonal antibody treatment.
✓. Agree to provide archival (collected within 2 years before signing the informed consent form if biopsy cannot be performed or participant refuses fresh biopsy) tumor tissue specimens for PD-L1 expression level testing and exploratory analysis of other biomarkers.
✓. Have at least one measurable lesion (target lesion) by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST v1.1. Lesions that have previously received radiotherapy or intratumoral injection can be used as measurable lesions if they show progression after treatment (either tissue confirmed or more than 3 months after treatment) as per RECIST v1.1.
What they're measuring
1
Overall Survival (OS)
Timeframe: 37 Months from First Patient In (FPI) (event driven)
✕. 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:
✕. 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.