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

NCT05253807 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration

A Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Incyte Corporation.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target
20
Study locations

NCT05253807: Completed Phase 2 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Incyte Corporation.

NCT05253807 is a Phase 2 study of Non-small Cell Lung Cancer (NSCLC) that has completed, run by Incyte Corporation. The registered enrollment target is 8 participants, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (97% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05253807, a Phase 2 study of Non-small Cell Lung Cancer (NSCLC), has completed, sponsored by Incyte Corporation.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, single arm study to study the safety, efficacy and tolerability of Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatment options

Primary Outcome

ORR was defined as the percentage of participants who achieved a complete response (CR) or a partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response was determined by an Independent Central Radiology (ICR) review. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappeara

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • DRUG Pemigatinib

Study Locations (20)

Other

  • H�PITAL NORD - CHU MARSEILLE - Marseille
  • Chu de Toulouse Hopital Larrey Centre de Reference Des Maladies Rares de La Peau Service de Dermatol - Toulouse
  • Zentralklinik Bad Berka Gmbh - Bad Berka
  • Lungenklinik Hemer - Hemer
  • Lki Lungenfachklinik Immenhausen - Immenhausen
  • University Hospital Mannheim - Mannheim
  • Irccs Centro Di Riferimento Oncologico - Aviano
  • Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari - Bari
  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori - Meldola
  • Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano - Orbassano
  • Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia - Perugia
  • Azienda Ospedaliero Universitaria Pisana - Pisa
  • Istituto Nazionale Tumori Regina Elena Irccs - Roma

Florida

  • Florida Cancer Specialists & Research Institute - Fort Myers
  • Miami Cancer Institute - Miami
  • Memorial Healthcare System - Pembroke Pines

California

  • Valkyrie Clinical Trials - Los Angeles

Kentucky

  • University of Kentucky Hospital - Lexington

Pennsylvania

  • Spoknwrd Clinical Trials Inc. - Easton

Tennessee

  • Tennessee Oncology - Nashville

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2022-04-29
Est. Completion 2023-08-16
Phase Phase 2
Incyte Corporation

239 total trials

What the finished NCT05253807 record still lists

NCT05253807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 1 intervention - of which Pemigatinib is the first listed.

NCT05253807 names 20 study sites across 6 states, led by Other, Florida, California.

Frequently Asked Questions

What is clinical trial NCT05253807 about?

NCT05253807 is a clinical study titled "Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration". This is an open-label, single arm study to study the safety, efficacy and tolerability of Pemigatinib when used on participants with squamous or nonsquamous NSCLC with a documented FGFR1-3 mutations or fusions/rearrangement who have progressed on prior therapies and have no available standard treatm...

What is the current status of trial NCT05253807?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2022-04-29. Estimated completion is 2023-08-16.

What conditions does trial NCT05253807 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT05253807?

The interventions under investigation include: Pemigatinib (DRUG).

Who is sponsoring clinical trial NCT05253807?

This trial is sponsored by Incyte Corporation, which has 239 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05253807 being conducted?

This trial has 20 study locations across California, Florida, Kentucky, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-small Cell Lung Cancer (NSCLC)

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 NCT05253807's enrollment target sits among peer trials

8 59th of 59 higher than 1 of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Related registry views

Source: ClinicalTrials.gov NCT05253807, the US trial registry maintained by the National Library of Medicine. NCT05253807 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.