SKB500 Combinations in Patients With Small Cell Lung Cancer
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
About this trial
The purpose of this study is to assess the safety, tolerability and preliminary antitumor activity of SKB500 combinations in patients with small cell lung cancer. The study is divided into two parts. Part 1 will be the safety run-in phase, and Part 2 will be the cohort expansion phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female participants between 18 and 75 years old.
Cohort 1: participant has received or not received prior systemic treatment, with no more than 1 prior systemic therapy in the extensive stage.
Cohort 2~3: participant has received no prior systemic treatment.
Agree to provide fresh or archival tumor tissue for biomarker analysis.
Disqualifiers
The pathology suggests the presence of both non-small cell carcinoma and small cell carcinoma components.
Has previously received medications with the same target or the same toxins.
Presence of spinal cord compression or clinically active central nervous system metastases.
Presence of clinical symptoms caused by tumor invasion or compression of important organs and blood vessels.
Trial design
Design model
Parallel
Treatments tested in this trial
SKB500 Powder for Injection
DrugSKB500 will be administered as an intravenous (IV) infusion, every 3 weeks on Day 1 of each 21-day cycle and the dose will be determined based on the efficacy and safety data from the SKB500-I-01 study.
KL-A167 Injection
DrugKL-A167 will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle (1200mg)
Carboplatin Injection
DrugCarboplatin will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle（AUC 5, Cycles 1-4)
Etoposide Injection
DrugEtoposide will be administered as an intravenous (IV) infusion every 3 weeks on Day 1, 2, and 3 of each 21-day cycle (100 mg/m\^2, Cycles 1-4).
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: 1. SKB500+KL-A167Experimental treatment 2 interventions
Group B: 2. SKB500 +KL-A167+CarboplatinExperimental treatment 3 interventions
Group C: 3. SKB500+KL-A167+Carboplatin+EtoposideExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame
up to 24 months2
Progression-free survival (PFS)
Progression-free survival (PFS) was defined as the time from baseline to the earliest date of the first objective documentation of progressive disease (PD) or death due to any cause.
Time frame
up to 24 monthsSecondary outcomes
1
Objective Response Rate (ORR)
Objective Response Rate (ORR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR), assessed by Investigator based on RECIST version 1.1.
Time frame
up to 24 months2
Duration of response (DOR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response \[PR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Time frame
up to 24 months3
Disease control rate (DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1.1, CR was defined as a disappearance of all lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Time frame
up to 24 months4
Overall Survival (OS)
The time from first dose to death from any cause.
Time frame
up to 24 monthsSponsors and contacts
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Source ClinicalTrials.gov