Sacituzumab Govitecan + Berzosertib for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Background:Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help.Objective:To find a safe combination of sacituzumab govitecan and berzosertib and to see if this will cause small cell lung cancer and PARP inhibitor resistant tumors to shrink.Eligibility:People ages 18 and older with a solid tumor, small cell lung cancer, or a homologous recombination-deficient cancer that is resistant to PARP inhibitorsDesign:Participants will be screened with:Standard clinical exams and testsEKG to test the heartMedical documentation to confirm cancer diagnosisParticipants will get sacituzumab govitecan by vein on days 1 and 8 of each 21-day cycle. They will get berzosertib by vein on days 2 and 9. Treatment will continue as long as they can tolerate the drugs and their tumors are either stable or getting better.Before treatment and at least once per cycle, participants will have a physical exam and blood tests. Before treatment and every 2 or 3 cycles, they will have a CT scan. They will have a contrast agent injected into a vein for the scan.Participants will give blood and hair samples and tumor biopsies for research. Biopsies will be taken with a small needle under imaging guidance.After they stop treatment, participants will have a visit 1 month later. They will then be contacted by phone or email every 3 months for the rest of their lives.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on other investigational drugs or certain medications that affect liver enzymes. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
What safety data exists for Sacituzumab Govitecan and Berzosertib in humans?
Sacituzumab Govitecan has been associated with side effects like neutropenia (low white blood cell count), diarrhea, colitis (inflammation of the colon), and sepsis (a severe infection), and these need close monitoring. Berzosertib has been studied in combination with other drugs for advanced solid tumors, but specific safety data for its use with Sacituzumab Govitecan in small cell lung cancer is not detailed in the available research.12345
What makes the drug Sacituzumab Govitecan + Berzosertib unique for treating small cell lung cancer?
This drug combination is unique because it includes Sacituzumab Govitecan, an antibody-drug conjugate that targets a specific protein (Trop-2) on cancer cells to deliver a chemotherapy agent directly to them, potentially improving effectiveness and reducing side effects compared to traditional chemotherapy.14678
What data supports the effectiveness of the drug Sacituzumab Govitecan + Berzosertib for Small Cell Lung Cancer?
Sacituzumab Govitecan has shown effectiveness in heavily pretreated small cell lung cancer patients, with 60% of patients experiencing tumor shrinkage and a median overall survival of 7.5 months. Additionally, Sacituzumab Govitecan has been effective in treating metastatic triple-negative breast cancer, suggesting its potential in other cancers.13469
Who Is on the Research Team?
Anish Thomas, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
Adults with certain advanced cancers, including small cell lung cancer and solid tumors resistant to PARP inhibitors. Participants must have a lesion safe for biopsy, measurable disease, stable brain metastases if present, good organ function, and no major treatments within specific time frames before the trial. They should not have severe genetic disorders affecting drug processing or uncontrolled illnesses that could hinder compliance.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sacituzumab govitecan on days 1 and 8 and berzosertib on days 2 and 9 of each 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Berzosertib
- Sacituzumab Govitecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor