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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase i

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ disease progression

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: MTD

Phase II: ORR

Secondary outcome measures

Duration of response

Overall survival (OS)

Progression free survival (PFS)

+2 more

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

Berzosertib

2021

Completed Phase 2

~80

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,988 Total Patients Enrolled

Anish Thomas, M.D.Principal InvestigatorNational Cancer Institute (NCI)

9 Previous Clinical Trials

727 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate figure of participants enrolled in this clinical study?

"Affirmative. Per the information found on clinicaltrials.gov, this medical study is actively recruiting participants. It was initially posted on September 20th 2021 and last updated October 20th 2022, with the aim of finding 85 patients at 1 site."

Answered by AI

Has the efficacy of Berzosertib been assessed in previous clinical experiments?

"Currently, 47 clinical studies are operational to research the efficacy of Berzosertib. Of those active trials, 5 have reached Phase 3 status. With Boston Massachusetts being its most concentrated hub, 1673 sites across the world are participating in this trial."

Answered by AI

What has been the primary application of Berzosertib?

"Berzosertib is frequently utilized in therapeutic procedures. This medication can be beneficial for the treatment of pharmacotherapy, uc 84572, and breast cancer alike."

Answered by AI

What are the primary goals of this clinical research endeavor?

"This clinical trial will track response rate (ORR) over a Phase I time frame as its primary endpoint. Secondary endpoints include toxicity grade and type, safety/tolerability, and duration of response; all of which are measured according to CTCAE v5.0 guidelines for Adverse Events (AE)."

Answered by AI

Are there current vacancies for participants in this research study?

"According to clinicaltrials.gov, the trial which started recruitment on September 20th 2021 is currently recruiting patients. The last update was made October 20th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

2021. "A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04826341.

All > Small Cell Lung Cancer