120 Participants Needed

Sacituzumab Govitecan + Berzosertib for Small Cell Lung Cancer

RV
AT
Overseen ByAnish Thomas, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AT

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

I can take care of myself and perform daily activities.
My brain metastases are stable and not causing new symptoms.
I am willing to have a biopsy and have at least one lesion that can safely be biopsied.
See 9 more

Exclusion Criteria

I have a blood disorder affecting my bone marrow or acute myeloid leukemia.
I have a specific genetic variant that affects drug processing.
I am infected with Hepatitis C.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive sacituzumab govitecan on days 1 and 8 and berzosertib on days 2 and 9 of each 21-day cycle

Until disease progression or intolerable side effects
2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month after treatment, then every 3 months for life
1 visit (in-person), then contact by phone or email

What Are the Treatments Tested in This Trial?

Interventions

  • Berzosertib
  • Sacituzumab Govitecan
Trial Overview The study is testing a combination of two drugs: Sacituzumab Govitecan and Berzosertib in patients with aggressive cancers like small cell lung cancer. The goal is to find a safe dosage that can shrink these tumors. Patients will receive the drugs intravenously on set days over 21-day cycles as long as they benefit without intolerable side effects.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment2 Interventions
Group II: 1/Phase IExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 50 patients with metastatic small cell lung cancer (mSCLC) who had been heavily pretreated, sacituzumab govitecan demonstrated a 14% objective response rate, with 60% of patients showing tumor shrinkage, indicating its potential efficacy as a treatment option.
The treatment was found to be generally safe, with manageable side effects; however, significant adverse events included neutropenia (34%) and fatigue (13%). This suggests that while effective, careful monitoring for side effects is necessary.
Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan.Gray, JE., Heist, RS., Starodub, AN., et al.[2022]
Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2 and has shown a 33.3% overall response rate in patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies, based on a phase I/II study with 108 participants.
The treatment has a median duration of response of 7.7 months, and while it is generally well-tolerated, common side effects include nausea, neutropenia, and fatigue, indicating a need for monitoring during treatment.
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer.Seligson, JM., Patron, AM., Berger, MJ., et al.[2021]
In a phase 1/2 trial involving 108 patients with heavily pretreated metastatic triple-negative breast cancer, sacituzumab govitecan-hziy demonstrated a response rate of 33.3%, with a median duration of response of 7.7 months, indicating its efficacy in this challenging patient population.
The treatment was associated with significant myelotoxic effects, including anemia and neutropenia, but overall survival was promising at a median of 13.0 months, highlighting the need for careful monitoring of side effects.
Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer.Bardia, A., Mayer, IA., Vahdat, LT., et al.[2019]

Citations

Therapy of Small Cell Lung Cancer (SCLC) with a Topoisomerase-I-inhibiting Antibody-Drug Conjugate (ADC) Targeting Trop-2, Sacituzumab Govitecan. [2022]
Sacituzumab Govitecan-hziy: An Antibody-Drug Conjugate for the Treatment of Refractory, Metastatic, Triple-Negative Breast Cancer. [2021]
Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. [2019]
Phase 1 study of the ATR inhibitor berzosertib (formerly M6620, VX-970) combined with gemcitabine ± cisplatin in patients with advanced solid tumours. [2023]
An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. [2023]
Postmarketing safety of Sacituzumab govitecan: a pharmacovigilance study based on FDA adverse event reporting system (FAERS). [2023]
FDA Approval Summary: Accelerated Approval of Sacituzumab Govitecan-hziy for Third-line Treatment of Metastatic Triple-negative Breast Cancer. [2022]
Cost-effectiveness of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer. [2023]
Sacituzumab Govitecan: First Approval. [2021]
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