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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 time from first administration of study treatment up to 27.7 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug called Berzosertib combined with an existing chemotherapy drug, Topotecan. It targets patients with a type of lung cancer that has come back and does not respond to standard treatments. Berzosertib makes the cancer cells weaker by stopping them from repairing themselves, and Topotecan attacks the cancer cells directly.

Eligible Conditions
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from first administration of study treatment up to 27.7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from first administration of study treatment up to 27.7 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Main Part: Objective Response Rate According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Independent Review Committee (IRC)
Safety Run-in Part: Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Emergent Adverse Events (TEAEs)
Safety Run-in Part: Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Findings
+3 more
Secondary study objectives
Main Part: Change From Baseline in Health State as Measured by Visual Analogue Scale (VAS) Component of European Quality of Life 5-dimensions 5 Level Scale (EQ-5D-5L)
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 Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by Independent Review Committee (IRC)
+32 more

Side effects data

From 2023 Phase 2 trial • 76 Patients • NCT04768296
100%
Anaemia
100%
Thrombocytopenia
67%
Alopecia
33%
Electrocardiogram QT prolonged
33%
Lipase increased
33%
Neutropenia
33%
Toothache
33%
Nausea
33%
Neuropathy peripheral
33%
Leukopenia
33%
Constipation
33%
Fatigue
33%
COVID-19
33%
Infusion related reaction
33%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Safety run-in Part (Dose Level 1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2
Safety run-in Part (DL2) + Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2

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: Safety run-in Part (Dose Level1 [DL 1]): Berzosertib 105 mg/m^2 + Topotecan 1.25 mg/m^2Experimental Treatment2 Interventions
Participants received Berzosertib at a dose of 105 milligrams per square meter (mg/m\^2 ) intravenously on Day 2 and Day 5 of each 21-daycycle in combination with Topotecan at a dose of 1.25mg/m\^2 intravenously on Days1 through 5 of each 21-day cycle in DL1 of safety run-in part until disease progression or other criteria for study intervention discontinuation are met.
Group II: Safety run-in Part (DL2) +Main Part: Berzosertib 210 mg/m^2 + Topotecan 1.25 mg/m^2Experimental Treatment2 Interventions
Participants received Berzosertib at a dose of 210 mg/m\^2 intravenously on Day 2 and Day 5 of each 21-day cycle in combination with Topotecan at a dose of 1.25 mg/m\^2 intravenously on Days 1 through 5 of each 21-day cycle in DL 1 and DL 2 of safety run-in part and main part 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
~2460
Berzosertib
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Merck KGaA, Darmstadt, GermanyIndustry Sponsor
443 Previous Clinical Trials
114,494 Total Patients Enrolled
EMD Serono Research & Development Institute, Inc.Lead Sponsor
83 Previous Clinical Trials
22,415 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
298 Previous Clinical Trials
60,849 Total Patients Enrolled
~17 spots leftby Oct 2025
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