A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

NCT05870319 | Active Not Recruiting Phase 3

• 1 other identifier: SKB264-Ⅲ-09
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus pemetrexed in combination with platinum in subjects with locally advanced or metastatic non-squamous NSCLC with EGFR mutation who have failed to EGFR-TKI therapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS assessed by BIRC per RECIST 1.1

  From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months

Secondary Outcomes (9)

• Overall survival (OS)

  From the date of randomization to the date of death due to any cause. Up to 2 years.

• Progression-free survival (PFS)

  From baseline until disease progression, death, or other protocol defined reason,up to approximately 36 months

• Objective response rate(ORR)

  Up to 2 years

• Disease control rate(DCR)

  Up to 2 years

• Duration of response(DOR)

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 36 months

Study Arms (2)

SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;

EXPERIMENTAL

Drug: SKB264

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

ACTIVE COMPARATOR

Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Interventions

SKB264 DRUG

intravenous (IV) infusion (Q2W)

SKB264 by IV infusion on Days 1 and 15 of each 4-week cycle;

Pemetrexed DRUG

500 mg/m2 intravenous (IV) infusion (Q3W)

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Carboplatin DRUG

AUC 5 intravenous (IV) infusion (Q3W) 4cycles

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Cisplatin DRUG

75 mg/m2 intravenous (IV) infusion (Q3W) 4cycles

pemetrexed+ carboplatin or on Day 1 of each 3-week cycle, with 4 cycles chemo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged ≥18 to ≤75 years at the time of signing the ICF;
• Histologically or cytologically confirmed non-squamous NSCLC and locally advanced (stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC not amenable to radical surgery and/or radical concurrent/sequential chemoradiotherapy;
• EGFR-sensitive mutations;
• Failure of prior EGFR-TKI therapy;
• At least one measurable target lesion per RECIST 1.1 as assessed by the investigator;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Expected survival ≥12 weeks;
• Adequate organ and bone marrow function;
• Female subjects of childbearing potential and male subjects with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
• Subjects voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures

You may not qualify if:

• Histologically or cytologically confirmed presence of small cell lung cancer, neuroendocrine carcinoma, and carcinosarcoma components or squamous cell carcinoma components of more than 10%;
• Other malignancies within 3 years prior to the first dose;
• History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis;
• Subjects with active chronic inflammatory bowel disease, GI tract obstruction, severe ulcers, perforation gastrointestinal, abdominal abscess, or acute GI tract bleed;
• Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1 (per NCI CTCAE 5.0) or to the level specified in the eligibility criteria;
• Subjects with human immunodeficiency virus (HIV) test positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;
• Prior TROP2-targeted therapy;
• Prior treatment with any drug therapy targeting topoisomerase I inhibitor, including antibody-drug conjugates (ADCs);
• Major surgery within 4 weeks prior to the first dose or expected to require major surgery during the study;
• Subjects who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
• Pregnant or lactating women;

Sponsors & Collaborators

• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Fang W, Wu L, Meng X, Yao Y, Zuo W, Yao W, Xie Y, Zhang Y, Cui J, Zhang Y, Li X, Zhuang W, Fang J, Wang Q, Jiang W, Li K, Bai Y, Luo Y, Ma F, Yu Y, Zheng W, Liu Z, Yang B, Ma R, Fang Y, Yang R, Jiang L, Hu J, Yang J, Diao Y, Jin X, Ge J, Yang Y, Zhang L. Sacituzumab Tirumotecan in EGFR-TKI-Resistant, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2026 Jan 1;394(1):13-26. doi: 10.1056/NEJMoa2512071. Epub 2025 Oct 19.

  PMID: 41124220 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

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: April 18, 2023
• First Posted: May 23, 2023
• Study Start: June 26, 2023
• Primary Completion: July 11, 2024
• Study Completion (Estimated): September 30, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (1)