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NCT07217301 · ClinicalTrials.gov registry record · Phase 3
IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed
A Phase 3 study of iO Resistant sqNSCLC, sponsored by Fortvita Biologics (USA).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
- 20
- Study locations
NCT07217301: Recruiting Phase 3 study of iO Resistant sqNSCLC, sponsored by Fortvita Biologics (USA).
NCT07217301 is a Phase 3 study of iO Resistant sqNSCLC that is actively recruiting participants, run by Fortvita Biologics (USA). The registered enrollment target is 600 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07217301, a Phase 3 study of iO Resistant sqNSCLC, is actively recruiting participants, sponsored by Fortvita Biologics (USA).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
cORR is defined as the proportion of participants with confirmed objective response rate (complete response \[CR\] or partial response \[PR\]) per RECIST V1.1 CR is defined as complete disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non- target) must have reduction in short axis to less than (\<) 10 mm. PR is defined as at least a 30 percent decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters.
Conditions Studied
Interventions
- DRUG IBI363
- DRUG Control Arm
Study Locations (20)
Anhui
- The First Affiliated Hospital of Anhui Medical University - Hefei
- Anhui Provincial Cancer Hospital - Hefei
- Anhui Provincial Hospital - Hefei
California
- Memorial Care - Fountain Valley
- Translation Research in Oncology- US, INC (TRIO-US) - Los Angeles
Beijing Municipality
- Peking University People's Hospital - Beijing
- Beijing Cancer Hospital - Beijing
Chongqing Municipality
- Chongqing University Cancer Hospital - Chongqing
- The First Affiliated Hospital of Chongqing Medical University - Chongqing
Fujian
- The Affiliated Hospital of Fujian Medical University - Fuzhou
- Fujian Cancer Hospital - Fuzhou
Guangdong
- Guangdong Provincial People's Hospital - Guangzhou
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University - Guangzhou
Henan
- The First Affiliated Hospital of Xinxiang Medical University - Xinxiang
- Henan Cancer Hospital - Zhengzhou
Arkansas
- St. Bernards Healthcare - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2025-11-26 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 3 |
What NCT07217301 shows while recruiting
NCT07217301 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 1 condition, with iO Resistant sqNSCLC appearing as the primary indexed condition, and to 2 interventions - of which IBI363 is the first listed.
NCT07217301 names 20 study sites across 12 states, led by Anhui, California, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT07217301 about?
NCT07217301 is a clinical study titled "IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed". 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) Stratif...
What is the current status of trial NCT07217301?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2025-11-26. Estimated completion is 2029-12-01.
What conditions does trial NCT07217301 study?
This clinical trial studies the following conditions: iO Resistant sqNSCLC.
What interventions are being tested in trial NCT07217301?
The interventions under investigation include: IBI363 (DRUG), Control Arm (DRUG).
Who is sponsoring clinical trial NCT07217301?
This trial is sponsored by Fortvita Biologics (USA), which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07217301 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Texas, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07217301's enrollment target sits among peer trials
600 608th of 2000 higher than 1,364 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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