Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06043817 · ClinicalTrials.gov registry record · Phase 1
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
A Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Pierre Fabre Medicament.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 251
- Enrollment target
- 20
- Study locations
NCT06043817: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, sponsored by Pierre Fabre Medicament.
NCT06043817 is a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC that is actively recruiting participants, run by Pierre Fabre Medicament. The registered enrollment target is 251 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06043817, a Phase 1 study of Non-Small Cell Lung Cancer and NSCLC, is actively recruiting participants, sponsored by Pierre Fabre Medicament.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 251 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.
Conditions Studied
Interventions
- DRUG STX-721/PFL-721 (Escalated)
- DRUG STX-721/PFL-721 (3 dose levels)
- DRUG STX-721/PFL-721 (RP2D)
Study Locations (20)
Other
- Institut Claudius Regaud - PPDS - Toulouse
- Gustave Roussy - Villejuif
- Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30 - Berlin
- Universitätsklinikum Carl Gustav Carus an der TU Dresden - Dresden
- Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis - Amsterdam
- Chungbuk National University Hospital - Cheongju-si
- CHA Bundang Medical Center, CHA University - Seongnam-si
- Seoul National University Hospital - Seoul
- Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON - Barcelona
California
- City of Hope - Duarte
- City of Hope - Huntington Beach
- City of Hope - Irvine
North Carolina
- Levine Cancer Institute - Charlotte - Charlotte
Pennsylvania
- Thomas Jefferson University Research Facility - Philadelphia
Tennessee
- SCRI Oncology Partners - PPDS - Nashville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Utah
- University of Utah - Huntsman Cancer Institute - PPDS - Salt Lake City
Virginia
- NEXT Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2023-09-26 |
| Est. Completion | 2029-12-01 |
| Phase | Phase 1 |
What NCT06043817 shows while recruiting
NCT06043817 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (62% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which STX-721/PFL-721 (Escalated) is the first listed.
NCT06043817 names 20 study sites across 10 states, led by Other, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT06043817 about?
NCT06043817 is a clinical study titled "First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations". Study STX-721-101/PFL-721CI101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721/PFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutatio...
What is the current status of trial NCT06043817?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 251 participants. The study started on 2023-09-26. Estimated completion is 2029-12-01.
What conditions does trial NCT06043817 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation.
What interventions are being tested in trial NCT06043817?
The interventions under investigation include: STX-721/PFL-721 (Escalated) (DRUG), STX-721/PFL-721 (3 dose levels) (DRUG), STX-721/PFL-721 (RP2D) (DRUG).
Who is sponsoring clinical trial NCT06043817?
This trial is sponsored by Pierre Fabre Medicament, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06043817 being conducted?
This trial has 20 study locations across California, North Carolina, Pennsylvania, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT06043817's enrollment target sits among peer trials
251 143rd of 454 higher than 312 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
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RECRUITING · Phase 1
-
Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC
RECRUITING · Phase 1
-
A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
RECRUITING · Phase 1
-
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in Patients With Advanced Non-small Cell Lung Cancer
RECRUITING · Phase 1
-
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02314988 · 252 participants · Phase 2
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
- NCT03941756 · 252 participants · NA
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
- NCT05219617 · 252 participants · Phase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
- NCT05384158 · 252 participants · NA
Valuation in Depressed Mood, Anhedonia, and Anxiety
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