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PARP Inhibitor

Berzosertib for Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, safety follow-up (up to 15 months)
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat small-cell lung cancer that has returned after initial treatment and is no longer responding to platinum-based drugs.

Eligible Conditions
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, safety follow-up (up to 15 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, safety follow-up (up to 15 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Main Part: Objective Response (OR) according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 as assessed by Independent Review Committee (IRC)
Safety Run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
Safety Run-in Part: Number of Participants with Clinically Significant Changes From Baseline in Vital Signs, 12-Lead Electrocardiogram (ECG) Findings and Laboratory Parameters
+1 more
Secondary outcome measures
Main Part: Change From Baseline in Cough, Dyspnea and Chest Pain Measured by European Organization for the Research and Treatment of Cancer Quality of Life and Lung Cancer Specific Questionnaire (EORTC QLQ-LC13)
Main Part: Change From Baseline in Physical Functioning Measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Main Part: Duration of Response (DoR) according to RECIST version 1.1 as assessed by IRC
+33 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Berzosertib + TopotecanExperimental Treatment2 Interventions
In Japan, a Safety Run-in Part will be conducted. In case safety and tolerability is confirmed in the Safety Run-in part, Japanese participants will enroll in the Main Part of the Phase 2. Both in the Safety Run-in and Main Part of the Phase 2, participants will receive berzosertib and topotecan until disease progression or other criteria for study intervention discontinuation are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topotecan
2017
Completed Phase 3
~2400
Berzosertib
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,580 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,784 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,899 Total Patients Enrolled

Frequently Asked Questions

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

What is the FDA's official opinion on Berzosertib?

"Berzosertib's safety was ranked a 2 because, while there is evidence that it is safe, Phase 2 trials have not yet demonstrated efficacy."

Answered by AI

How many patients are included in this research project?

"No, this study is not seeking patients at the moment. The listing for this trial was first posted on March 29th 2021 and updated as recently as November 11th 2022. However, there are 1609 other clinical trials actively recruiting small cell lung carcinoma patients and 74 studies Berzosertib currently looking for participants."

Answered by AI

Is this the first time Berzosertib has been used in a research setting?

"Berzosertib was first studied in the year 2005 at St. Jude Children's Research Hospital. Since then there have been 146 completed clinical trials worldwide, with 74 active studies currently underway - a large number of these in Grand Rapids, Michigan."

Answered by AI

Are there a lot of places conducting this clinical trial in North America?

"At the moment, there are 13 different centres running this clinical trial. They are located in Grand Rapids, Pinehurst and Fort Worth as well other locations. If you want to enroll in the trial, try to select a centre near you to limit travel time and effort."

Answered by AI

What are the primary reasons that doctors prescribe Berzosertib?

"Berzosertib is used to treat ovarian cancer but can also be given to patients with leukemia, myelocytic, acute, and sarcoma."

Answered by AI

Are there still opportunities for participants in this experiment?

"Presently, this clinical trial is not admitting any more patients into the study. The original posting was on March 29th, 2021 and the last edit was November 11th, 2022. If you are seeking other studies, 1609 trials for small cell lung carcinoma and 74 studies for Berzosertib are actively recruiting right now."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
What site did they apply to?
FirstHealth of the Carolinas, Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I want to raise my kids with my wife and done tried treatments and not working.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)
2021. "Berzosertib + Topotecan in Relapsed Platinum-Resistant Small-Cell Lung Cancer (DDRiver SCLC 250)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04768296.
~19 spots leftby Apr 2025
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