New drug combo targets Tough-to-Treat cancers
NCT ID NCT04802174
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether combining two drugs, lurbinectedin and berzosertib, can shrink tumors in people with small cell lung cancer or high-grade neuroendocrine cancers. These cancers often stop responding to standard chemotherapy. The trial includes 37 adults and aims to find the safest and most effective dose. Participants receive the drugs through an IV and are monitored with scans and blood tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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37 people
The number who actually took part.
- Started
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Jun 2021
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: * Both Phase I and Phase II: * \>= 18 years of age. * ECOG performance status \<= 2 * Measurable disease, per RECIST 1.1. Individuals with evaluable, but not measurable disease will be eligible for Phase I. * Adequate organ functions * Hemoglobin \>= 9.0 g/dL * Absolute neutrophil count \>= 1.5x10\^9/L * Platelets \>= 100x10\^9/L * Total Bilirubin \<= 2.0 mg/dL * Transaminases \<= 2 x ULN or if liver metastases were present, \<= 3 x ULN * Creatinine \<= 1.5 mg/dL or creatinine clearance by Cockcroft-Gault formula \>= 60 mL/min * Ability to understand and the willingness to sign a written informed consent document. * Individuals of child-bearing potential (IOCBP) and individuals able to father a child 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 IOCBP and for 4 months after lurbinectedin or 3 months after berzosertib for individuals able to father children. 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. EXCLUSION CRITERIA: * 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 individuals are excluded from this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors