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NCT04971187 · ClinicalTrials.gov registry record · Phase 2

Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT04971187: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT04971187 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04971187, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

This phase II trial studies the effect of bintrafusp alfa with pemetrexed and platinum-based chemotherapy (carboplatin or cisplatin) in treating patients with EGFR mutant non-small cell lung cancer that have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) and cannot be removed by surgery, and remains despite treatment with tyrosine kinase inhibitors (Resistant). Immunotherapy with bintrafusp alfa, a bifunctional fusion protein composed of the monoclonal antibody anti-PD-L1 and TGF-beta, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pemetrexed may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving bintrafusp alfa with pemetrexed and platinum-based chemotherapy may help to control the disease.

Primary Outcome

Objective response was assessed by RECIST 1.1. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • DRUG Bintrafusp Alfa

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-06-30
Est. Completion 2022-02-21
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

Why NCT04971187 stopped before completion

NCT04971187 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.

NCT04971187 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04971187 about?

NCT04971187 is a clinical study titled "Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer". This phase II trial studies the effect of bintrafusp alfa with pemetrexed and platinum-based chemotherapy (carboplatin or cisplatin) in treating patients with EGFR mutant non-small cell lung cancer that have spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metas...

What is the current status of trial NCT04971187?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2021-06-30. Estimated completion is 2022-02-21.

What interventions are being tested in trial NCT04971187?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Bintrafusp Alfa (DRUG).

Who is sponsoring clinical trial NCT04971187?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04971187's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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 NCT04971187, the US trial registry maintained by the National Library of Medicine. NCT04971187 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.