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A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003)

NCT05816252 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2026-01-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and objective response rate of SKB264 as combination with therapy in subjects with advanced or metastatic non-small cell lung cancer.

Conditions

Interventions

DRUG

SKB264

intravenous (IV) infusion (Q2W or Q3W)

DRUG

Pembrolizumab

intravenous (IV) infusion (400mg, Q6W)

DRUG

Carboplatin

intravenous (IV) infusion (AUC5, Q3W)

DRUG

Osimertinib

80mg, QD

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Klus Pharma Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-19
Primary Completion
2026-06-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • China
  • Georgia
  • Romania
  • South Korea
  • Spain
  • Turkey (Türkiye)

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 NCT05816252 on ClinicalTrials.gov