A Study of SKB518 in Patients With Lung Cancer
ConditionLung Carcinoma
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 SKB518 in patients with lung cancer. Eligible subjects will receive SKB518 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.
Eligibility criteria
Qualifiers
Age between 18 and 75 years old at the time of signing the informed consent form, applicable to both males and females.
Non-small cell lung cancer (NSCLC) or small cell lung cancer(SCLC) confirmed by histology or cytology.
At least one measurable tumor lesion per RECIST v1.1.
Performance status score of 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale.
Disqualifiers
Symptomatic or uncontrolled cardiovascular disease
History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD;
Subjects with the disease that requires systemic corticosteroid therapy (prednisolone or equivalent dose of similar drugs at a dose of >10 mg/d) or other immunosuppressive therapy within 14 days before the first dose.
Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
Trial design
Treatments tested in this trial
- SKB518
- Tislelizumab
- Carboplatin
Treatment groups
192 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov