RecruitingPhase 3NCT07217301

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

A Randomized, Open-Label, Multi-center, Phase 3 Study Evaluating the Efficacy and Safety of IBI363 Versus Docetaxel in Participants With Unresectable Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer With Disease Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy

Sponsor

Fortvita Biologics (USA)Inc.

Enrollment

600 participants

Start Date

Nov 26, 2025

Study Type

INTERVENTIONAL

Conditions

iO Resistant sqNSCLC

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called IBI363 against a standard chemotherapy drug called docetaxel in people with advanced squamous non-small cell lung cancer (a type of lung cancer) whose disease has kept growing despite previous treatments, including immunotherapy and platinum-based chemotherapy. **You may be eligible if...** - You are 18 or older and have confirmed squamous non-small cell lung cancer (NSCLC) that has spread or cannot be surgically removed - Your cancer continued to grow during or within 6 months after stopping immunotherapy (anti-PD-1/PD-L1 treatment) - You have at least one tumor that can be measured on a scan - You are willing to provide a tumor tissue sample **You may NOT be eligible if...** - Your lung cancer contains mixed small cell or other non-squamous components - You have not yet received platinum-based chemotherapy or immunotherapy - You are not well enough to tolerate cancer treatment - You have active, untreated brain metastases Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIBI363

Investigational product will be administered by IV infusion

DRUGControl Arm

Comparator product will be administered by IV infusion

Locations(44)

St. Bernards Healthcare

Jonesboro, Arkansas, United States

Memorial Care

Fountain Valley, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Translation Research in Oncology- US, INC (TRIO-US)

Los Angeles, California, United States

D & H Cancer Research Center

Margate, Florida, United States

BRCR Global

Plantation, Florida, United States

The University of Texas M.D Anderson Cancer Ceneter (MDACC)

Houston, Texas, United States

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, Shannxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

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NCT07217301