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A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Phase II Interventional Non-Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SKB571 for injection, Osimertinib, Furmonertinib, carboplatin.
Who it may be relevant to
Registry conditions: Non-Small Cell Lung Cancer. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase II Clinical Study to Evaluate the Efficacy and Safety of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

Overview

This is an open-label, multicenter, phase II study. The purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of SKB571 Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC).

Detailed description

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.

Interventions

  • Drug SKB571 for injection
    Intravenous(IV) infusion(Q3W)
  • Drug Osimertinib
    orally once daily
  • Drug Furmonertinib
    orally once daily
  • Drug carboplatin
    Intravenous(IV) infusion(Q3W)
  • Drug Cisplatin
    Intravenous(IV) infusion(Q3W)
  • Drug Pembrolizumab
    Intravenous(IV) infusion(Q3W)

Primary outcome measures

  • Objective response rate (ORR) [Time frame: Up to approximately 36 months]
Secondary outcome measures (9)
  • Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS) [Time frame: Up to approximately 36 months]
  • Safety and tolerability [Time frame: Up to approximately 36 months]
  • Maximum Plasma Concentration (Cmax) of SKB571-ADC [Time frame: Up to approximately 36 months]
  • Immunogenicity [Time frame: Up to approximately 36 months]
  • Minimum Plasma Concentration(Cmin) of SKB571-ADC [Time frame: Up to approximately 36 months]
  • Maximum Plasma Concentration(Cmax) of SKB571-TAb [Time frame: Up to approximately 36 months]
  • Minimum Plasma Concentration(Cmin) of SKB571-TAb [Time frame: Up to approximately 36 months]
  • Maximum Plasma Concentration (Cmax) of unconjugated KL610348 [Time frame: Up to approximately 36 months]
  • Minimum Plasma Concentration(Cmin) of unconjugated KL610348 [Time frame: Up to approximately 36 months]

Eligibility criteria

Inclusion criteria

  • Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
  • Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
  • At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks as assessed by the investigator.
  • Adequate organ and bone marrow function.
  • Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
  • Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion criteria

  • Participants with other malignant tumors within 3 years before the first dose of study treatment.
  • Active or untreated central nervous system (CNS) metastasis.
  • Current uncontrolled concomitant diseases
  • Clinically severe lung damage due to complications of lung disorder
  • Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
  • A history of severe skin diseases
  • Unresolved toxicity from prior anti-tumor therapy
  • Serious infection within 4 weeks before the first dose of study treatment
  • Known active pulmonary tuberculosis.
  • Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
  • Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
  • Pregnant or breastfeeding women.
  • Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 27 centers
  • Peking University Cancer Hospital — Beijing
  • Xinqiao Hospital of Army Medical University — Chongqing
  • Fujian Provincial Cancer Hospital — Fuzhou
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • Dongguan People's Hospital — Dongguan
  • Sun Yat-sen University Cancer Center — Guangzhou
  • Guangzhou Medical University First Affiliated Hospital — Guangzhou
  • Guilin Medical University First Affiliated Hospital — Guilin
  • … and 19 more centers

Identifiers

NCT: NCT07622186 · SKB571-II-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗