Health TrialsbyHealthPanel

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

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SKB571 for injection

    Drug

    Intravenous(IV) infusion(Q3W)

  • Osimertinib

    Drug

    orally once daily

  • Furmonertinib

    Drug

    orally once daily

  • carboplatin

    Drug

    Intravenous(IV) infusion(Q3W)

  • Cisplatin

    Drug

    Intravenous(IV) infusion(Q3W)

  • Pembrolizumab

    Drug

    Intravenous(IV) infusion(Q3W)

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: NSCLC with sensitive EGFR mutationsExperimental treatment 3 interventions
Group B: NSCLC with EGFR wild-typeExperimental treatment 4 interventions
Group C: NSCLC with uncommon EGFR mutationsExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

Time frame
Up to approximately 36 months

Secondary outcomes

1

Progression-free survival (PFS), duration of response (DOR), disease control rate (DCR), and overall survival (OS)

Time frame
Up to approximately 36 months
2

Safety and tolerability

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (based on CTCAE v6.0), clinically significant abnormal laboratory test results, etc.

Time frame
Up to approximately 36 months
3

Maximum Plasma Concentration (Cmax) of SKB571-ADC

Blood Samples will be collected to determine the Cmax of SKB571-ADC in the plasma

Time frame
Up to approximately 36 months
4

Immunogenicity

Blood Samples will be collected to measure Anti-drug antibody (ADA) against SKB571 in the serum

Time frame
Up to approximately 36 months

Other outcomes

1

Correlation between biomarkers and efficacy

To evaluate the correlation between the expression levels of tumor-related genes in tumor tissues and efficacy

Time frame
Up to approximately 36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
Apply now