A Study of MHB088C Injection Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This study was designed to compare the efficacy and safety of MHB088C for Injection with treatment of physician's choice (TPC) in participants with relapsed small cell lung cancer (SCLC).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily consent to participate in this study and sign the informed consent form.
Adults ≥18 years, regardless of gender.
ECOG performance status score of 0-1.
Estimated survival time of more than 3 months.
Disqualifiers
Diagnosis of other primary malignancies within 5 years prior to signing the informed consent form.
Prior pathological diagnosis of combined SCLC, or any transformed non-small cell lung cancer or transformed SCLC.
Receipt of chemotherapy within 4 weeks prior to the first administration of study drug, or receipt of radiotherapy, biologics, endocrine therapy, immunotherapy, or other anti-tumor therapy within 4 weeks prior to the first dose.
Previous or ongoing treatment with topoisomerase I inhibitors, including antibody-drug conjugates (ADCs) containing topoisomerase I inhibitor payloads.
Trial design
Design model
Parallel
Treatments tested in this trial
MHB088C for Injection
Drug2 mg/kg intravenous dose on Day 1 and Day 15 of each 28-day cycle
Topotecan
Drug1.25 mg/m\^2 intravenous dose on Day 1 to Day 5 of each 21-day cycle
Irinotecan
Drug65 mg/m\^2 intravenous dose on Day 1 and Day 8 of each 21-day cycle
Paclitaxel
Drug135 mg/m\^2 intravenous dose on Day 1 of each 21-day cycle
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: MHB088C for InjectionExperimental treatment 1 intervention
Group B: Treatment of Physician's Chioce (TPC)Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Overall Survival
Time frame
From the date of randomization to the date of death due to any cause, up to approximately 5 yearsSecondary outcomes
1
Number of Participants With Objective Response Rate Assessed by Investigator
Confirmed objective response rate (ORR) is defined as the sum of the complete response (CR) rate and partial response (PR) rate based on investigator by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years2
Progression-free Survival As Assessed by Investigator
PFS is defined as the time interval from the date of randomization to the date of disease progression as per investigator assessment or death due to any cause.
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 years3
Duration of Response As Assessed by Investigator
Duration of response (DoR) is 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 documentation of progressive disease (PD) or death. The DoR will be calculated for responding participants (PR or CR) only.
Time frame
From the date of first documentation of confirmed response (CR or PR) to the first documentation of objective progression or to death due to any cause, whichever occurs first, up to approximately 5 years4
Disease Control Rate As Assessed by Investigator
Disease control rate is defined as the proportion of participants who have achieved a best overall response of confirmed CR, confirmed PR, or SD (or non-CR/non-PD) by investigator assessment per RECIST v1.1.
Time frame
Baseline up until documented progressive disease, death, lost to follow-up, or withdrawal by the participant, up to approximately 5 yearsSponsors and contacts
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Source ClinicalTrials.gov