Non-Small Cell Lung Cancer study: STX-721/PFL-721
Official title 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
ClinicalTrials.gov ID: NCT06043817
What this study is testing
What is STX-721/PFL-721?
An investigational oral medication being studied for non‑small cell lung cancer with EGFR or HER2 exon 20 insertion mutations.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe the drug is, how the body handles it, and whether it shows early signs of fighting the cancer.
- Who it's for
- It is for adults with non‑small cell lung cancer that has an EGFR or HER2 exon 20 insertion mutation and whose cancer is locally advanced or has spread.
- What's involved
- Participants will receive the drug and have regular visits for safety checks, blood tests, and imaging to monitor the cancer.
- Time commitment
- The study lasts about 6 months, with multiple clinic visits and tests scheduled throughout that period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
- Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories.
- Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible.
- Has documented tumor progression (based on radiological imaging)
- Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic...
You likely can't join if
- Has a tumor that is known to harbor EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a...
- Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
- Has symptomatic brain or spinal metastases
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral...
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could...
See the full eligibility criteria
- Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation
- Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR/HER2 exon 20 insertion mutations confirmed by qualified local laboratories
- Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of approved treatment for advanced or...
- Has documented tumor progression (based on radiological imaging)
- Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling
- Has at least one measurable tumor lesion per RECIST v1.1
- Is ≥18 years of age at the time of signing the ICF
- Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Key
- Has a tumor that is known to harbor EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or C797S resistance mutations
- Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC
- Has symptomatic brain or spinal metastases
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy
- Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or...
The study team makes the final eligibility decision.
Where it is enrolling
- Duarte, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Charlotte, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Fairfax, Virginia, United States
- Camperdown, New South Wales, Australia
- Saint-Herblain, Loire-Atlantique, France
- Bordeaux, France
- Lille, France
- Lyon, France
- Marseille, France
- Toulouse, France
- Villejuif, France
- Berlin, Germany
- Dresden, Germany
- Amsterdam, Netherlands
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Duarte, California, United States; Huntington Beach, California, United States; Irvine, California, United States; Charlotte, North Carolina, United States; Philadelphia, Pennsylvania, United States; Nashville, Tennessee, United States and 24 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.