A Study of SKB264 in Combination With Osimertinib Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutations, Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

NCT06670196 | Recruiting Phase 3 DMC

• 1 other identifier: SKB264-Ⅲ-15
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the study is to evaluate the efficacy and safety of SKB264 in combination with osimertinib as first-Line treatment for patients with epidermal growth factor receptor (EGFR) mutations, locally advanced or metastatic non-squamous non-small cell lung cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

SKB264; NSCLC

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)

  PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on BICR or death due to any cause, whichever occurs first.

  Randomization up to approximately 36 months

Secondary Outcomes (6)

• Overall Survival (OS)

  Randomization up to approximately 49 months

• Progression-Free Survival (PFS) assessed by Investigator

  Randomization up to approximately 36 months

• Objective Response Rate (ORR)

  Randomization up to approximately 36 months

• Disease control rate (DCR)

  Randomization up to approximately 36 months

• Duration of Response (DoR)

  Randomization up to approximately 36 months

Study Arms (2)

SKB264+Osimertinib

EXPERIMENTAL

Participants will receive SKB264 on Day 1 and Day 15 of each 4-week cycle, Osimertinib once-daily for each 4-week cycle.

Drug: SKB264; Drug: Osimertinib

Osimertinib

ACTIVE COMPARATOR

Participants will receive Osimertinib once-daily for each 4-week cycle.

Drug: Osimertinib

Interventions

SKB264 DRUG

4mg/kg, intravenous (IV) infusion

SKB264+Osimertinib

Osimertinib DRUG

80mg, QD

Osimertinib; SKB264+Osimertinib

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years to ≤75 years at the time of signing the informed consent form (ICF), regardless of gender.
• Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC not eligible to radical surgery and/or radical radiotherapy.
• No prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
• Histologically or cytologically confirmed EGFR-sensitive mutations.
• Tumor tissue samples obtained at or after the diagnosis of locally advanced or metastatic tumor are eligible.
• At least one target lesion assessed by the investigator based on RECIST v1.1.
• ECOG performance status score of 0 or 1 within 7 days prior to randomization.
• Life expectancy ≥ 12 weeks.
• Adequate organ and bone marrow function.

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%.
• Subjects who have received prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.
• Subjects who have received any of the following therapies (including the adjuvant/neoadjuvant therapy):
• Targeted TROP2 therapy;
• Any drug therapy that targets topoisomerase I, including antibody-drug conjugates (ADCs).
• Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or central nervous system (CNS) metastase.
• Other malignancies within 3 years prior to randomization.
• Clinically significant abnormalities found on resting electrocardiogram (ECG)
• Presence of any of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.
• History of interstitial lung disease (ILD), drug-induced ILD, history of non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis.
• Clinically severe lung injuries caused by lung diseases.
• Subjects who have received systemic corticosteroids \> 10 mg/day of prednisone or other immunosuppressive agents within 2 weeks prior to randomization.
• Known active pulmonary tuberculosis.
• Known history of allogeneic organ transplant and allogeneic hematopoietic stem cell transplant.
• Presence of active hepatitis B or hepatitis C.

Sponsors & Collaborators

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

Study Sites (2)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xiaoping Jin PhD

CONTACT

86-028-67255165; jinxp@kelun.com

Study Design

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

Model Details: Participants will be randomised in a 1:1 ratio to one of two intervention groups.

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 1, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CN (2)