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NCT04396535 · ClinicalTrials.gov registry record · Phase 2

Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer

A Phase 2 study, sponsored by Mayo Clinic.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT04396535: Clinical Trial Phase 2 study, sponsored by Mayo Clinic.

NCT04396535 is a Phase 2 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04396535, a Phase 2 study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

This phase II trial studies how well docetaxel works with or without bintrafusp alfa in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Chemotherapy drugs, such as docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with bintrafusp alfa, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving docetaxel and bintrafusp alfa in combination may work better in treating non small-cell lung cancer compared to docetaxel alone.

Primary Outcome

The primary analysis of PFS will be a comparison of the Kaplan-Meier curves for docetaxel + bintrafusp alfa vs. docetaxel alone using a one-sided log-rank test.

Interventions

  • DRUG Docetaxel
  • DRUG Bintrafusp Alfa

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2020-10-23
Est. Completion 2023-12-31
Phase Phase 2
Mayo Clinic

2,844 total trials

Why NCT04396535 stopped before completion

NCT04396535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.

NCT04396535 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04396535 about?

NCT04396535 is a clinical study titled "Docetaxel With or Without Bintrafusp Alfa for the Treatment of Advanced Non-small Cell Lung Cancer". This phase II trial studies how well docetaxel works with or without bintrafusp alfa in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). Chemotherapy drugs, such as docetaxel, work in different ways to stop the growth of cancer cells, either b...

What is the current status of trial NCT04396535?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2020-10-23. Estimated completion is 2023-12-31.

What interventions are being tested in trial NCT04396535?

The interventions under investigation include: Docetaxel (DRUG), Bintrafusp Alfa (DRUG).

Who is sponsoring clinical trial NCT04396535?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04396535's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04396535, the US trial registry maintained by the National Library of Medicine. NCT04396535 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.