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NCT05681780 · ClinicalTrials.gov registry record · Phase 1

Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC

A Phase 1 study of Non-Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Active
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT05681780: Active Phase 1 study of Non-Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT05681780 is a Phase 1 study of Non-Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 13 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05681780, a Phase 1 study of Non-Small Cell Lung Cancer and Stage IV Non-small Cell Lung Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

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

Study Summary

To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

Primary Outcome

To characterize the safety profile of CD40L-augmented TIL administered with nivolumab.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Nivolumab
  • BIOLOGICAL Tumor-infiltrating Lymphocytes (TIL)
  • OTHER Tumor-infiltrating Lymphocyte Therapy

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2023-03-10
Est. Completion 2027-12
Phase Phase 1

What the registry record for NCT05681780 still lists

NCT05681780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower).

The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT05681780 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT05681780 about?

NCT05681780 is a clinical study titled "Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC". To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung cancer.

What is the current status of trial NCT05681780?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2023-03-10. Estimated completion is 2027-12.

What conditions does trial NCT05681780 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non-small Cell Lung Cancer.

What interventions are being tested in trial NCT05681780?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Nivolumab (DRUG), Tumor-infiltrating Lymphocytes (TIL) (BIOLOGICAL), Tumor-infiltrating Lymphocyte Therapy (OTHER).

Who is sponsoring clinical trial NCT05681780?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05681780 being conducted?

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

Similar trials for Non-Small Cell Lung Cancer

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.

Where NCT05681780's enrollment target sits among peer trials

13 434th of 454 higher than 19 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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 NCT05681780, the US trial registry maintained by the National Library of Medicine. NCT05681780 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.