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Protocol Details

A Phase I/II Trial of Lurbinectedin with Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High Grade Neuroendocrine Cancers

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;



Recruitment Keyword(s)



Small cell cancer;
Advanced solid tumor;
High Grade Neuroendocrine Cancers

Investigational Drug(s)


Investigational Device(s)



Drug: Lurbinectedin
Drug: Berzosertib

Supporting Site

National Cancer Institute


Small cell lung cancer (SCLC) and high-grade neuroendocrine cancers (HGNEC) are aggressive neuroendocrine cancers. At first, SCLC and HGNEC respond to chemotherapy. But then they relapse quickly and become resistant to treatment. Researchers want to see if a combination of drugs can help.


To see if the combination of lurbinectedin and berzosertib may be effective to shrink SCLC and HGNEC tumors, and to find the best dose of the combination.


Adults ages 18 and older with a solid tumor, SCLC, or HGNEC.


Participants will get lurbinectedin by intravenous (IV) catheter on Day 1 of each cycle (1 cycle = 21 days). They will get berzosertib by IV on Days 1 and 2 of each cycle.

Participants will continue to receive treatment as long as they are benefiting from treatment.

Participants will have physical exams and blood tests. Their symptoms, medicines, and ability to perform their normal activities will be reviewed.

Participants will have electrocardiograms to test heart function. Sticky pads will be placed on their chest, arms, and legs.

Participants will give blood and hair samples for research. They may have optional tumor biopsies.

Participants will have computed tomography (CT) scans to see if the treatment is effective.

Participants will have a follow-up visit 1 month after treatment ends. Then they will be followed by email or phone for the rest of their life.

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- Both Phase I and Phase II:

- Male and female, greater than or equal to 18 years of age.

- ECOG performance status less than or equal to 2

- Measurable disease, per RECIST 1.1. Individuals with evaluable, but not measurable disease will be eligible for Phase I.

- Adequate organ functions

-- Hemoglobin greater than or equal to 9.0 g/dL

-- Absolute neutrophil count greater than or equal to 1.5x10(9)/L

-- Platelets greater than or equal to 100x10(9)/L

-- Total Bilirubin less than or equal to 2.0 mg/dL

-- Transaminases less than or equal to 2 x ULN or if liver metastases were present, less than or equal to 3 x ULN

-- Creatinine less than or equal to 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula greater than or equal to 60 mL/min

- Ability to understand and the willingness to sign a written informed consent document.

- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during study participation and for 6 months after the last dose of berzosertib/lurbinectedin for women and for 4 months after lurbinectedin or 3 months after berzosertib for men. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Phase I:

- Histologically confirmed advanced solid cancers will be eligible.

- At least one prior chemotherapy

Phase II:

- Histological confirmation of SCLC or HGNEC. Although NCI confirmation of pathology is not required prior to starting treatment, every effort will be made to obtain outside pathology to be reviewed by an NCI pathologist.


- Individuals with tumor amenable to potentially curative therapy.

- Currently receiving any other investigational agents.

- Received chemotherapy, or undergone major surgery within the prior 2 weeks and radiotherapy within the last 24 hours.

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to (study agent) or other agents used in study.

- Symptomatic brain metastases will be excluded from trial secondary to poor prognosis. However, individuals who have had treatment for their brain metastasis and whose brain disease is stable without steroid therapy for 1 week or on physiologic doses of steroids may be enrolled.

- Requirement for any medications or substances that are strong inhibitors or inducers of CYP3A during the course of the study are ineligible.

- Evidence of severe or uncontrolled systemic disease, or any concurrent condition, which could compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction within the past 6 months, uncontrolled cardiac arrhythmia, stroke/cerebrovascular accident within the past 6 months, or psychiatric illness/social situations which would jeopardize compliance with the protocol.

- HIV-positive on or off combination antiretroviral therapy are ineligible.

- Pregnant women are excluded from this study.

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Not Provided

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Principal Investigator

Referral Contact

For more information:

Anish Thomas, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-5330
(240) 760-7343

Rasa Vilimas, R.N.
National Cancer Institute (NCI)
National Institutes of Health
Building 10
Room 8D44
10 Center Drive
Bethesda, Maryland 20892
(240) 858-3158

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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