Actively Recruiting
IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed
Led by Fortvita Biologics (USA)Inc. · Updated on 2026-04-27
600
Participants Needed
44
Research Sites
209 weeks
Total Duration
On this page
Sponsors
F
Fortvita Biologics (USA)Inc.
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
IBI363 vs Docetaxel in Patients With Advanced Squamous Lung Cancer After Standard Treatments Have Failed
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to sign informed consent and follow study procedures
- Male or female 18 years or older
- Diagnosed with locally unresectable advanced or metastatic squamous NSCLC
- Resistant or refractory to platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy
- Radiographic progression per RECIST v1.1 during or within 6 months after anti-PD-1/PD-L1 treatment
- Agree to provide tumor tissue for PD-L1 and biomarker testing
- Have at least one measurable lesion by CT or MRI per RECIST v1.1
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Agree to effective contraception during treatment and for 6 months after
- Lactating women must abstain from breastfeeding during treatment and for 6 months after
You will not qualify if you...
- Pregnant or lactating women, or those planning pregnancy during or within 6 months after treatment
- Known actionable genomic alterations including mutations in EGFR, KRAS G12C, ALK, ROS1, BRAF V600E, NTRK fusions, MET exon 14 skipping, RET, ERBB2, or others with approved targeted therapies
- Active or symptomatic brain metastases unless stable for at least 4 weeks and meeting specific criteria
- Significant blood abnormalities including low hemoglobin, neutrophil count, or platelet count at baseline
- Abnormal liver or kidney function tests beyond specified limits
- Coagulation abnormalities beyond specified limits
- Recent serious thromboembolic events within 3 months
- Active uncontrolled bleeding or known bleeding tendency
- Significant cardiovascular or cerebrovascular diseases
- History of certain lung diseases requiring steroids or severe pulmonary conditions
- Severe allergies, asthma, or hypersensitivity reactions
- Significant gastrointestinal diseases or recent grade 2 or higher diarrhea
- Active autoimmune disease requiring systemic treatment within 2 years
- History of organ or stem cell transplantation
- Known allergy to study drugs or excipients
- Prior severe toxicity from immune checkpoint inhibitors requiring therapy discontinuation
- Unresolved moderate or higher toxicity from previous cancer treatments
- Recent major surgery within 4 weeks before starting study drug
- Uncontrolled tumor-related pain or hypercalcemia
- Uncontrolled infections including HIV with low CD4, active syphilis, hepatitis B or C, or tuberculosis
- Serious or uncontrolled infection requiring IV antibiotics or recent fever
- Psychiatric or substance abuse conditions affecting consent or participation
- Other uncontrolled diseases or conditions compromising safety or compliance
- Recent other malignancies within 5 years except certain treated cancers
- Prior use of excluded medications or therapies such as docetaxel or multiple anti-PD-1/PD-L1 therapies
- Recent chemotherapy, antibody therapy, radiotherapy, live vaccines, immunosuppressive or systemic steroids, or traditional Chinese medicine with anti-tumor effects before starting study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 44 locations
1
St. Bernards Healthcare
Jonesboro, Arkansas, United States, 72401
Actively Recruiting
2
Memorial Care
Fountain Valley, California, United States, 92708
Actively Recruiting
3
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States, 90720
Actively Recruiting
4
Translation Research in Oncology- US, INC (TRIO-US)
Los Angeles, California, United States, 90025
Actively Recruiting
5
D & H Cancer Research Center
Margate, Florida, United States, 33024
Actively Recruiting
6
BRCR Global
Plantation, Florida, United States, 33322
Actively Recruiting
7
The University of Texas M.D Anderson Cancer Ceneter (MDACC)
Houston, Texas, United States, 77030
Actively Recruiting
8
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
9
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230088
Not Yet Recruiting
10
Anhui Provincial Hospital
Hefei, Anhui, China, 231501
Actively Recruiting
11
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Not Yet Recruiting
12
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
13
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
14
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400042
Actively Recruiting
15
The Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
Actively Recruiting
16
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350014
Actively Recruiting
17
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
18
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
Actively Recruiting
19
The Fourth Hospital of Hebei University
Shijiazhuang, Hebei, China, 050011
Actively Recruiting
20
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
21
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Actively Recruiting
22
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
23
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
24
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
25
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410205
Actively Recruiting
26
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Withdrawn
27
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
28
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
29
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221006
Actively Recruiting
30
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
31
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110042
Actively Recruiting
32
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
33
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
34
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433
Not Yet Recruiting
35
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, Shannxi, China, 710061
Actively Recruiting
36
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610213
Actively Recruiting
37
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 611135
Not Yet Recruiting
38
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Actively Recruiting
39
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
40
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
41
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
42
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
43
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
44
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
Research Team
F
Farah Dahman, MPA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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