MedTrace Logo

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

NCT07217301 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-04-27

No results posted yet for this study

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

Conditions

  • iO Resistant sqNSCLC

Interventions

DRUG

IBI363

Investigational product will be administered by IV infusion

DRUG

Control Arm

Comparator product will be administered by IV infusion

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • Fortvita Biologics (USA)Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2028-11-01
Completion
2029-12-01
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07217301 on ClinicalTrials.gov