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

NCT07217301 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CIBI363C301
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 44

Brief 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. 1.Primary vs. acquired IO resistance
2. 2.Concurrent vs. sequential prior chemo-immunotherapy
3. 3.Region (Asia vs. non-Asia)
4. 4.IBI363 Arm (Investigational Drug):
5. 5.Control Arm (Docetaxel):

Conditions

iO Resistant sqNSCLC

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  To compare the overall survival (OS) of IBI363 (treatment group) vs. docetaxel (control group) in participants with unresectable locally advanced or metastatic squamous NSCLC with disease progression on or after platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy.

  37 Months from First Patient In (FPI) (event driven)

Secondary Outcomes (11)

• Progression-free survival (PFS)

  44 months

• Objective Response Rate (ORR)

  44 months

• Disease Control Rate (DCR)

  44 months

• Duration of Response (DOR)

  44 momths

• Time to Response (TTR)

  44 months

Other Outcomes (11)

• Exploratory: Baseline and Time to Deterioration in EORTC QLQ-C30 Global Health Status / Quality of Life (QoL) Score

  44 months

• Exploratory: Baseline and Time to Deterioration in EORTC QLQ-C30 Symptom and Functional Scales

  44 monthd

• Exploratory: Baseline and Time to Deterioration in EQ-5D-5L Index Score

  44 months

Study Arms (2)

IBI363

EXPERIMENTAL

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.

Drug: IBI363

Control

ACTIVE COMPARATOR

Docetaxel or comparable generic brand

Drug: Control Arm

Interventions

IBI363 DRUG

Investigational product will be administered by IV infusion

IBI363

Control Arm DRUG

Comparator product will be administered by IV infusion

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to sign the written informed consent form and be able to comply with the visit schedule and related procedures specified in the protocol.
• Male or female participants must be at least 18 years old or the legal age of majority in their country, whichever is greater.
• Have locally unresectable advanced or metastatic histologically or cytologically confirmed squamous NSCLC Note: Mixed small cell carcinoma, or other pathological components are excluded.
• Resistant or refractory to systemic anti-tumor therapy, including platinum-based doublet chemotherapy and primary or secondary resistance to anti-PD-1/PD-L1 monoclonal antibody given in combination or sequentially; or given as neoadjuvant and/or adjuvant therapy, which will be considered first-line treatment if the disease has recurred or progressed during such treatment or within 6 months after discontinuation.
• Radiographic progression per RECIST v1.1 during or within 6 months after discontinuation of anti-PD-1/PD-L1 monoclonal antibody treatment.
• Agree to provide archival (collected within 2 years before signing the informed consent form if biopsy cannot be performed or participant refuses fresh biopsy) tumor tissue specimens for PD-L1 expression level testing and exploratory analysis of other biomarkers.
• Have at least one measurable lesion (target lesion) by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST v1.1. Lesions that have previously received radiotherapy or intratumoral injection can be used as measurable lesions if they show progression after treatment (either tissue confirmed or more than 3 months after treatment) as per RECIST v1.1.
• ECOG PS score of 0 or 1.
• Expected survival time ≥ 3 months.
• Women of childbearing potential (WOCBP) or men with female partners of childbearing potential must agree to take effective contraceptive measures during the entire course of treatment and for 6 months after the last dose of study treatment.
• Lactating women must agree to strictly abstain from breastfeeding during the entire Treatment Period and for 6 months after the treatment.

You may not qualify if:

• Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of any study drug. WOCBP or fertile men with WOCBP partner(s), not using and/or not willing to use a highly effective method of contraception.
• Known actionable genomic alteration, including any of the following driver gene mutations:
• Epidermal growth factor receptor (EGFR): including exon 19 deletion, exon 21 L858R, exon 20 T790M, exon 20 S768I, exon 21 L861Q, exon 18 G719X, and exon 20 insertion mutations.
• Kirsten rate sarcoma virus (KRAS) G12C mutation.
• Anaplastic lymphoma kinase (ALK) rearrangement.
• ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) rearrangement.
• B-Raf proto-oncogene, serine/threonine kinase (BRAF) V600E mutation.
• Neurotrophic tyrosine receptor kinase (NTRK) 1/2/3 fusion.
• MET proto-oncogene, receptor tyrosine kinase (MET) exon 14 skipping mutation.
• RET proto-oncogene (RET) rearrangement.
• V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 2 (ERBB2, also known as HER2) mutation.
• Other gene mutation types where a targeted therapy has been completely approved for marketing by a local regulatory authority.
• Note: It is not mandatory to have undergone driver gene testing.
• Active or symptomatic brain metastases. Participants who are clinically and radiologically stable at least 4 weeks after treatment and participants with small, asymptomatic, incidental, untreated brain metastases that remain stable ≥ 4 weeks may participate in this study as long as they meet all of the following criteria:
• No metastases to meninges, midbrain, pons, medulla oblongata, spinal cord or cerebellar metastases.

Sponsors & Collaborators

• Fortvita Biologics (USA)Inc.: lead
• Takeda: collaborator
• Innovent Biologics (Suzhou) Co. Ltd.: collaborator

Study Sites (44)

St. Bernards Healthcare

Jonesboro, Arkansas, 72401, United States

RECRUITING

Memorial Care

Fountain Valley, California, 92708, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

RECRUITING

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

Los Angeles, California, 90025, United States

RECRUITING

D & H Cancer Research Center

Margate, Florida, 33024, United States

RECRUITING

BRCR Global

Plantation, Florida, 33322, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

RECRUITING

Anhui Provincial Cancer Hospital

Hefei, Anhui, 230088, China

NOT YET RECRUITING

Anhui Provincial Hospital

Hefei, Anhui, 231501, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

NOT YET RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

The Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, 510095, China

RECRUITING

The Fourth Hospital of Hebei University

Shijiazhuang, Hebei, 050011, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410205, China

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

WITHDRAWN

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, 110042, China

RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'An Jiaotong University

Xi'an, Shannxi, 710061, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610213, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 611135, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

NOT YET RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325015, China

NOT YET RECRUITING

Central Study Contacts

Farah Dahman, MPA

CONTACT

farah.dahman@fortvitabio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2025
• First Posted: October 15, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (7); CN (37)