A Single Arm Phase II Study Evaluating Intracranial Efficacy of Sacituzumab Govitecan (SG) With Bevacizumab in Patients With Active, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:

‣ 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.

⁃ Pathology proven metastatic non-squamous NSCLC

⁃ For those without an actionable oncogenic driver: progression on immunotherapy and/or platinum-doublet chemotherapy (concurrent or sequential, in any order). If contra-indication for immunotherapy: progression on platinum-doublet chemotherapy.

⁃ For those with an actionable oncogenic driver: progression on targeted therapy and platinum-doublet chemotherapy. For the latter group, previous ICI is allowed but not mandatory.

⁃ BM not in eloquent area (all patients have at least to be discussed with a neurologist, and preferably they are discussed in the local neuro-oncology MDT).

⁃ Maximum BM size 2 cm in longest diameter (for each BM).

‣ At least one untreated brain metastasis ≥ 5mm:

⁃ Patients with largest measurable intracranial lesion ≥5 mm but \<10 mm may be allowed to enroll upon agreement with the principal investigator (for patients with target lesions of ≥ 5mm but \<10 mm, 1.5 mm slice thickness brain MRI is required).

• Prior local treatment is permissible provided unequivocal progression in the lesion has since occurred (discussed in neuro-oncology MDT) or if new lesions have occurred.

• For at least 7 days prior to first dose of SG and bevacizumab in this study: Patient must be asymptomatic from CNS metastases and on a stable dose of corticosteroids, with a maximum of 4 mg dexamethasone/day. Anti-epileptic dose should also be stable for 7 days.

‣ Participant must have recovered from all toxicities related to prior treatments to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion are alopecia and neuropathy of any grades.

‣ Adequate organ function including the following laboratory values at the screening visit:

• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without growth factor support),

∙ Platelets ≥ 100 x 109/L (without growth factor support),

∙ Hemoglobin (Hb) ≥ 6 mmol/l (= 9 g/dl) (7 days without transfusions or growth factor support),

∙ Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases

∙ Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases

∙ Serum albumin \> 3 g/dL

∙ Total bilirubin ≤ 1.5 ULN,

∙ Creatinine clearance ≥ 30 mL/min by calculation using Cockcroft-Gault formula or based on 24-hour urine sample assessment.

‣ Participant is capable of following instructions regarding study treatment administration, and must be able to communicate with the Investigator and comply with the requirements of the study procedures.

‣ Negative serum or urine pregnancy test within 7 days prior to study treatment in women with childbearing potential. Patient must be willing to use effective methods of contraception. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 4 months after termination of study drug.

Locations
Other Locations
Netherlands
NKI-AvL
RECRUITING
Amsterdam
University Medical Center Groningen
RECRUITING
Groningen
Maastricht University Medical Center
RECRUITING
Maastricht
Contact Information
Primary
Lizza Hendriks, MD, PhD
lizza.hendriks@mumc.nl
+31(0)43-3875047
Time Frame
Start Date: 2025-04-24
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 25
Treatments
Experimental: sacituzumab govitecan (SG) plus bevacizumab
SG 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.
Sponsors
Leads: Maastricht University Medical Center
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov

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