A Phase II Study of SKB264 + SKB118 in Nsq-NSCLC After EGFR-TKI Failure
Trial statusNot yet recruiting
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 clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR-sensitizing mutations who have failed EGFR-TKI therapy. 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 (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent chemotherapy has been received).
Confirmed EGFR-sensitizing mutations.
Participants must have failed prior EGFR-TKI therapy for locally advanced or metastatic disease.
Participants must be confirmed during the screening period to be able to provide a tumor tissue sample. If this cannot be met, acceptability should be discussed with the medical monitor.
Disqualifiers
Histologically or cytologically confirmed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid carcinoma components, or with a squamous component of more than 10%.
Presence of known driver gene alterations with approved targeted therapies.
Participants with known metastases to meninges, brainstem metastases, spinal cord metastases and/or compression, active or untreated brain metastases.
Participants with other malignant tumors within 3 years prior to the first dose.
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
110 Participants
are divided into 1 treatment groupGroup A: SKB264 in combination with SKB118Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The safety of SKB264 in combination with SKB118 in participants with non-squamous non-small cell lung cancer (NSCLC)
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (per Common Terminology Criteria for Adverse Events \[CTCAE\] v6.0)
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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