Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04802174 · ClinicalTrials.gov registry record · Phase 1

Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers

A Phase 1 study of Advanced Solid Tumor and SCLC, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
37
Enrollment target
1
Study location

NCT04802174 is a Phase 1 study of Advanced Solid Tumor and SCLC that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 37 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04802174, a Phase 1 study of Advanced Solid Tumor and SCLC, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
37 participants
Enrollment target
1
Study location

Study Summary

Background: 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. Objective: 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. Eligibility: Adults ages 18 and older with a solid tumor, SCLC, or HGNEC. Design: 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.

Conditions Studied

Advanced Solid Tumor SCLC Small Cell Cancer High Grade Neuroendocrine Cancers

Interventions

  • DRUG Lurbinectedin
  • DRUG Berzosertib

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2021-06-01
Est. Completion 2027-12-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04802174

The ClinicalTrials.gov registry entry for NCT04802174 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (81% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which Lurbinectedin is the first listed.

NCT04802174 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04802174 about?

NCT04802174 is a clinical study titled "Lurbinectedin With Berzosertib, an ATR Kinase Inhibitor in Small Cell Cancers and High-Grade Neuroendocrine Cancers". Background: 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 hel...

What is the current status of trial NCT04802174?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-06-01. Estimated completion is 2027-12-01.

What conditions does trial NCT04802174 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, SCLC, Small Cell Cancer, High Grade Neuroendocrine Cancers.

What interventions are being tested in trial NCT04802174?

The interventions under investigation include: Lurbinectedin (DRUG), Berzosertib (DRUG).

Who is sponsoring clinical trial NCT04802174?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04802174 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Advanced Solid Tumor

All registered trials for this condition

SCLC

All registered trials for this condition

Maryland

All trials with a study site in Maryland

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.