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A Phase III Study of SKB264 for EGFR Mutant NSCLC Patients

NCT05870319 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 376

Last updated 2026-05-08

No results posted yet for this study

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

Interventions

DRUG

SKB264

intravenous (IV) infusion (Q2W)

DRUG

Pemetrexed

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

DRUG

Carboplatin

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

DRUG

Cisplatin

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

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-26
Primary Completion
2024-07-11
Completion
2026-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05870319 on ClinicalTrials.gov