Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMaastricht University Medical Center
About this trial
This study will evaluate whether the combination of sacituzumab govitecan (SG) and bevacizumab will result in shrinkage of brain metastases from patients with non-squamous non-small cell lung cancer (NSCLC), with disease progression on chemotherapy and immunotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent must be obtained prior to participation in the study.
Participant is an adult ≥ 18 years of age at the time of informed consent.
ECOG performance status ≤1.
Estimated life expectancy of 12 weeks or more.
Disqualifiers
Leptomeningeal metastasis (based on MRI or CSF cytology, if strong suspicion despite negative MRI, CSF analysis should be done).
Previous treatment with TROP2 inhibitor or angiogenesis inhibitor.
Known hypersensitivity to the study drugs, its metabolites, or formulation excipient.
Positive serum pregnancy test or women who are breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab Govitecan-Hziy 180 MG plus bevacizumab
DrugSacituzumab govitecan 10mg/kg intravenous day 1 and day 8 of a 21-day cycle, + bevacizumab 15 mg/kg iv day 1 of a 21-day cycle till unacceptable toxicity or disease progression.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: sacituzumab govitecan (SG) plus bevacizumabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
brain metastases overall response rate (ORR)
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI
Time frame
up to 24 monthsSecondary outcomes
1
brain metastases overall response rate (ORR) with correction for bevacizumab-pseudoresponse
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI with additional criteria for potential pseudo response due to bevacizumab
Time frame
up to 24 months2
brain metastases disease control rate (DCR)
DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Non-CR/Non-PD according to RANO-BM on brain MRI
Time frame
up to 24 months3
CNS progression free survival (PFS)
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. PFS is based on local and central assessment according to RANO-BM on brain MRI
Time frame
up to 24 months4
Extracranial ORR and DCR
ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment, DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Non-CR/Non-PD according to RECIST 1.1, measured with CT
Time frame
up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maastricht University Medical Center
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov