Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer
ConditionNon Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorSTCube, Inc.
About this trial
A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed stage IIIb, IIIc, or IV 4 recurrent non-squamous NSCLC
BTN1A1 TPS score ≥50
Subjects with positive AGA must have progressed after At least 1 platinum-based chemotherapy and/or immunotherapy AND at least 1 locally approved targeted therapy appropriate to the AGA
Subjects with negative AGA must have progressed after prior PD1/ (PDL therapy and/or platinum-based chemotherapy
Disqualifiers
Known hypersensitivity to the active ingredients or excipients of the study drug.
History of using Docetaxel for palliative therapy.
Prior treatment with Cytotoxic chemotherapy or oral targeted therapy within 14 days.
Investigational drugs within 5 half-lives.
Trial design
Design model
Single group
Treatments tested in this trial
Nelmastobart and Docetaxel
DrugNelmastobart 800mg and Docetaxel 75mg/m2
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Nelmastobart 800mg+Docetaxel 75mg/m2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival by central reviewer
Time from first dose until the date of objective disease progression or death assessed by central reviewer
Time frame
up to 3 yearsSecondary outcomes
1
Overall survival
Time from first dose of study drug until the date of death
Time frame
up to 3 years2
Progression Free Survival assessed by Investigator
Time from first dose until the date of objective disease progression or death
Time frame
Up to 3 years3
Objective response rate, ORR
Proportional of subjects with confirmed PR/CR, assessed by investigator and central reviewer
Time frame
Up to 3 years4
Disease control rate, DCR
Proportion of subjects with confirmed CR, PR, and SD assessed by investigator and central reviewer based on RECIST v1.1
Time frame
Up to 3 yearsOther outcomes
1
Quality of life measured by EQ-5D-5L
Change from Baseline in Patient Reported Outcome EQ-5D-5L at Treatment Cycle 2 and beyond
Time frame
until the end of treatment (Up to 3 years)Sponsors and contacts
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Source ClinicalTrials.gov