IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed

Conditions

• iO Resistant sqNSCLC

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IBI363 — DRUG
  Investigational product will be administered by IV infusion
• Control Arm — DRUG
  Comparator product will be administered by IV infusion

Study Details

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

Key Dates

Start date

Nov 26, 2025

Status verified

Apr 2026

Primary completion

Nov 1, 2028

Completion

Dec 1, 2029

Study Design

Enrollment

600 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IBI363
  IBI363 is a first-in-class bispecific monoclonal antibody (mAb) comprised of an interleukin-2 (IL-2) mutein fused with a recombinant anti-programmed cell death protein 1 (anti-PD-1) mAb. IBI363 was precisely designed and constructed to afford targeted binding of tumor-specific CD8+ T cells (TSTs) that co-express PD-1 and CD25 (IL2Ra) receptors. The mechanism of action of IBI363 is blocking the PD-(L)1 and activating the IL-2 pathways simultaneously to reverse T cell exhaustion and promote activation of T cells and natural killer (NK) cells, and consequently eliminate tumor cells.
• Active Comparator: Control
  Docetaxel or comparable generic brand

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: 37 Months from First Patient In (FPI) (event driven) ]

Central Contacts

• Farah Dahman, MPA
  [email protected]

Locations (7)

Find similar trials in Jonesboro, AR