Non-Small Cell Lung CancerPhase 1/2NCT06043817
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 1/2 study testing STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels) and STX-721/PFL-721 (RP2D) in people with Non-Small Cell Lung Cancer and NSCLC, run by Pierre Fabre Medicament at 32 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, NSCLC, EGFR/HER2 Exon 20 Insertion Mutation
- What is being tested?
- STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels) and STX-721/PFL-721 (RP2D)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 32 sitesin 8 countries
- Study dates
- 26 Sep 2023to 1 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
- 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
Who cannot join
- 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 confound the protocol-specified assessments
Trial locations and contacts
32 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Adele De MASSON, clinical development director, MD, PhD contact
32 sites in 8 countries
United States9 sites, 9 recruiting
- Recruiting
Levine Cancer Institute - Charlotte
Charlotte, North Carolina, 28204-2990
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031-2171
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
- Recruiting
City of Hope
Huntington Beach, California, 92648
- Recruiting
City of Hope
Irvine, California, 92618
- Recruiting
SCRI Oncology Partners - PPDS
Nashville, Tennessee, 37203
- Recruiting
Thomas Jefferson University Research Facility
Philadelphia, Pennsylvania, 19107
- Recruiting
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, 84112-5550
France7 sites, 7 recruiting
- Recruiting
Institut Bergonie - PPDS
Bordeaux, 33076
- Recruiting
CHU de Lille - Hopital Claude Huriez
Lille, 59000
- Recruiting
Centre Léon Bérard
Lyon, 69008
- Recruiting
AP-HM- Hôpital de La Timone
Marseille, 13005
- Recruiting
EDOG Institut de Cancerologie de l'Ouest - PPDS
Saint-Herblain, Loire-Atlantique, 44115
- Recruiting
Institut Claudius Regaud - PPDS
Toulouse, 31059
- Recruiting
Gustave Roussy
Villejuif, 94800
Spain6 sites, 6 recruiting
- Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 8035
- Recruiting
START - Rioja Hospital Universitario San Pedro
Logroño, La Rioja, 26006
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Regional Universitario de Malaga - Hospital General
Málaga, Malaga, 29010
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
South Korea4 sites, 4 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28644
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
CHA Bundang Medical Center, CHA University
Seongnam-si, 13496
- Recruiting
Seoul National University Hospital
Seoul, 03080
Germany2 sites, 2 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30
Berlin, 12203
- Recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 10002
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Australia1 site, 1 recruiting
- Recruiting
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, 2050
Netherlands1 site, 1 recruiting
- Recruiting
Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, 1066
About this study
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.
- Being tested
- STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels), STX-721/PFL-721 (RP2D), STX-721/PFL-721 (Escalated) with platinum-based chemotherapy, STX-721/PFL-721 with platinum-based chemotherapy
- Keywords
- Exon 20, EGFR, HER2, NSCLC, TKI
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STX-721/PFL-721 (Escalated)Drug
STX-721/PFL-721 dose will be escalated per cBLRM-design.
STX-721/PFL-721 (3 dose levels)Drug
Participants will receive STX-721/PFL-721 at one of three dose levels.
STX-721/PFL-721 (RP2D)Drug
Participants will receive the RP2D of STX-721/PFL-721.
STX-721/PFL-721 (Escalated) with platinum-based chemotherapyDrug
STX-721/PFL-721 in combination with platinum-based chemotherapy dose will be escalated per iBOIN-design.
STX-721/PFL-721 with platinum-based chemotherapyDrug
Participants will receive STX-721/PFL-721 at dose selected in Part 1b in combination with platinum-based chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | Not described Receives: Drug: STX-721/PFL-721 (Escalated) |
| Part 1b: Dose Escalation | Experimental | Not described Receives: Drug: STX-721/PFL-721 (Escalated) with platinum-based chemotherapy |
| Part 2a: RP2D Selection | Experimental | Not described Receives: Drug: STX-721/PFL-721 (3 dose levels) |
| Part 2b: RP2D Selection | Experimental | Not described Receives: Drug: STX-721/PFL-721 with platinum-based chemotherapy |
| Part 3: Dose Expansion | Experimental | Not described Receives: Drug: STX-721/PFL-721 (RP2D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment
Measured: 28 days
Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment
Measured: 28 days
Part 2 RP2D Selection: C(max) of STX-721/PFL-721
Measured: 1 year
Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721
Measured: 1 year
Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-721
Measured: 1 year
Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-721
Measured: 1 year
Part 2 RP2D Selection: Number of participants with confirmed objective response rate (ORR) defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 per investigator assessment.
Measured: 1 year
Part 3 Dose Expansion: Number of participants with confirmed ORR defined as the percentage of participants with PR or CR based on RECIST v1.1 per investigator assessment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start26 Sep 2023
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043817
- Sponsor's protocol ID
- STX-721-101/PFL-721CI101
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- STX-721-101/PFL-721CI101
- Keywords
- Exon 20, EGFR, HER2, NSCLC, TKI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1a: Dose Escalation | Experimental | Drug: STX-721/PFL-721 (Escalated) |
| Part 1b: Dose Escalation | Experimental | Drug: STX-721/PFL-721 (Escalated) with platinum-based chemotherapy |
| Part 2a: RP2D Selection | Experimental | Drug: STX-721/PFL-721 (3 dose levels) |
| Part 2b: RP2D Selection | Experimental | Drug: STX-721/PFL-721 with platinum-based chemotherapy |
| Part 3: Dose Expansion | Experimental | Drug: STX-721/PFL-721 (RP2D) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
- 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
Key exclusion criteria (5 listed)
- 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 confound the protocol-specified assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STX-721/PFL-721 (Escalated)STX-721/PFL-721 dose will be escalated per cBLRM-design. | Drug | Part 1a: Dose Escalation |
| STX-721/PFL-721 (3 dose levels)Participants will receive STX-721/PFL-721 at one of three dose levels. | Drug | Part 2a: RP2D Selection |
| STX-721/PFL-721 (RP2D)Participants will receive the RP2D of STX-721/PFL-721. | Drug | Part 3: Dose Expansion |
| STX-721/PFL-721 (Escalated) with platinum-based chemotherapySTX-721/PFL-721 in combination with platinum-based chemotherapy dose will be escalated per iBOIN-design. | Drug | Part 1b: Dose Escalation |
| STX-721/PFL-721 with platinum-based chemotherapyParticipants will receive STX-721/PFL-721 at dose selected in Part 1b in combination with platinum-based chemotherapy. | Drug | Part 2b: RP2D Selection |
Primary outcome
Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment
Time frame: 28 days
Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment
Time frame: 28 days
Part 2 RP2D Selection: C(max) of STX-721/PFL-721
Time frame: 1 year
Part 2 RP2D Selection: AUC(0-inf) of STX-721/PFL-721
Time frame: 1 year
Part 2 RP2D Selection: AUC(0-t) of STX-721/PFL-721
Time frame: 1 year
Part 2 RP2D Selection: AUC(0-τ) of STX-721/PFL-721
Time frame: 1 year
Part 2 RP2D Selection: Number of participants with confirmed objective response rate (ORR) defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 per investigator assessment.
Time frame: 1 year
Part 3 Dose Expansion: Number of participants with confirmed ORR defined as the percentage of participants with PR or CR based on RECIST v1.1 per investigator assessment.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adele De MASSON, clinical development director, MD, PhD contact
32 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STX-721/PFL-721 (Escalated), STX-721/PFL-721 (3 dose levels) and STX-721/PFL-721 (RP2D) in people with Non-Small Cell Lung Cancer and NSCLC, run by Pierre Fabre Medicament at 32 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Spain, South Korea, Germany and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adele De MASSON, clinical development director, MD, PhD (33 772344916, PFL721_medical.team@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment (time frame: 28 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.