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PARP Inhibitor

Berzosertib for 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

Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from first administration of study treatment up to 27.7 months

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%

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