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Sacituzumab Govitecan + Berzosertib for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Anish Thomas, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status less than or equal to 2
Participants with neurologically stable brain metastases
Must not have
Participants with myelosuppressive disorders or acute myeloid leukemia
Participants known to be homozygous for the UGT1A1*28 variant allele with severely reduced UGT1A1 activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up phase i
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of drugs to see if it can help people with small cell lung cancer or tumors resistant to PARP inhibitors.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, heart issues due to EKG changes, allergic responses similar to other chemotherapy agents used in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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My brain metastases are stable and not causing new symptoms.
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I am willing to have a biopsy and have at least one lesion that can safely be biopsied.
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My advanced cancer has worsened despite having at least one chemotherapy treatment.
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My small cell lung cancer has returned after platinum-based treatment.
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I am 18 years old or older.
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My cancer is HRD positive with documented evidence.
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I haven't had chemotherapy, major surgery in the last 2 weeks, or radiotherapy in the last 24 hours.
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My organs and bone marrow are working well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a blood disorder affecting my bone marrow or acute myeloid leukemia.
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I have a specific genetic variant that affects drug processing.
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I have chronic hepatitis B.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I don't need drugs that strongly affect liver enzymes during my trial treatment.
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I am not currently on any experimental drugs or other cancer treatments.
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I have brain metastasis causing symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease progression
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease progression for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase I: MTD
Phase II: ORR
Secondary study objectives
Duration of response
Overall survival (OS)
Progression free survival (PFS)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment2 Interventions
Sacituzumab Govitecan and Berzosertib treatment with identified MTD based on phase I.
Group II: 1/Phase IExperimental Treatment2 Interventions
Dose escalated Sacituzumab Govitecan and Berzosertib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan
2019
Completed Early Phase 1
~30
Berzosertib
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,917 Previous Clinical Trials
41,014,345 Total Patients Enrolled
Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)
9 Previous Clinical Trials
796 Total Patients Enrolled

Media Library

Berzosertib (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04826341 — Phase 1 & 2
Small Cell Lung Cancer Research Study Groups: 2/Phase II, 1/Phase I
Small Cell Lung Cancer Clinical Trial 2023: Berzosertib Highlights & Side Effects. Trial Name: NCT04826341 — Phase 1 & 2
Berzosertib (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04826341 — Phase 1 & 2
~34 spots leftby Mar 2026
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