SKB264 in Combination With SKB118 for Non-Small Cell Lung Cancer
ConditionNSCLC
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, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed locally advanced or metastatic NSCLC
Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
Provide a tumor tissue sample.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Disqualifiers
Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
Uncontrolled systemic disease as judged by the investigator.
Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
Trial design
Design model
Single group
Treatments tested in this trial
SKB264+SKB118
DrugAdministered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.
Treatment groups
206 Participants
are divided into 1 treatment groupGroup A: SKB264 in combination with SKB118Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.
Time frame
From enrollment to the end of treatment at 24 months2
ORR(objective response rate)
ORR as assessed by the investigator based on RECIST v1.1
Time frame
From enrollment to the end of treatment at 24 monthsSecondary outcomes
1
DCR(Disease control rate )
as assessed by the investigator based on RECIST v1.1
Time frame
From enrollment to the end of treatment at 24 months2
DOR(duration of response )
as assessed by the investigator based on RECIST v1.1
Time frame
From enrollment to the end of treatment at 24 months3
PFS(progression-free survival)
as assessed by the investigator based on RECIST v1.1
Time frame
From enrollment to the end of treatment at 24 months4
OS (overall survival)
Time frame
From enrollment to the end of treatment at 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov