Non-Small Cell Lung CancerPhase 2NCT06933329
Zelenectide Pevedotin in NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study testing Zelenectide pevedotin in people with Non-Small Cell Lung Cancer, run by BicycleTx Limited at 3 sites in 2 countries.
Trial summary
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Zelenectide pevedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 18 Jul 2025to 28 Feb 2029
- Phase
- Phase 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
- Histologically or cytologically confirmed advanced or metastatic NSCLC.
- Cohort A: Histologically or cytologically confirmed non-squamous NSCLC.
- Cohort B: Histologically or cytologically confirmed squamous NSCLC.
- Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
- Participants must have received at least 1 prior line of systemic therapy in the advanced/metastatic setting.
- Participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic NSCLC. Must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting.
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- Participants with known actionable genomic alterations (eg, EGFR, ALK, BRAF, MET, ROS1, NTRK1/2/3, RET, etc.) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting.
- Measurable disease as defined by RECIST v1.1.
- Adequate archival or fresh tumor tissue comprised of advanced or metastatic NSCLC should be available for submission to central laboratory, if not provided during prescreening.
- Life expectancy ≥ 12 weeks.
- Eastern Cooperative Oncology Group Performance Status of ≤ 1.
Who cannot join
- Evidence of mixed small cell lung cancer (SCLC) and NSCLC histology.
- Prior treatment with monomethyl auristatin E (MMAE) (vedotin) based therapy.
- Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
- Ongoing clinically significant toxicity (Grade ≥ 2) associated with prior treatment for NSCLC (including radiotherapy or surgery), with the exception of well-controlled immuno-oncology related endocrine disorders on supportive or replacement therapy, and alopecia. (Note: Immunosuppressive therapies should be stopped or tapered down to ≤10 mg/day prednisone or equivalent before first study drug administration.)
- Active keratitis or corneal ulcerations.
- Active or untreated central nervous system (CNS) metastases.
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- Uncontrolled diabetes or hypertension.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently).
- Active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (>10mg/day of prednisone or equivalent) or other immunosuppressive medications; or any prior history of ILD or non-infectious pneumonitis requiring high-dose glucocorticoids.
- History of another active malignancy, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other malignancies curatively treated with no evidence of disease for ≥3 years.
- Known requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome P450 3A ([cytochrome P450 3A] CYP3A) including herbal- or food-based inhibitors/inducers.
- Prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment.
- Note: Additional protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Universitario 12 de Octubre
Madrid, 28041
About this study
Official title: Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Zelenectide pevedotin
- Keywords
- NECTIN4, Zelenectide pevedotin, Advanced or Metastatic, NSCLC, Chemotherapy, Non-Squamous, Squamous
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zelenectide pevedotinDrug
Also called BT8009
Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (non-squamous NSCLC) | Experimental | Not described Receives: Drug: Zelenectide pevedotin |
| Cohort B (squamous NSCLC) | Experimental | Not described Receives: Drug: Zelenectide pevedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
Measured: Up to approximately 3 years
Secondary outcomes (7)
Number of participants reporting adverse events (AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs
Safety will be reported as incidence, severity, seriousness, relationship to study treatment, and types of adverse events using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 criteria.
Measured: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 assessed by the Investigator
DoR as measured by the time from first documentation of disease progression per RECIST v1.1 or to death (due to any cause), whichever occurs first.
Measured: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 assessed by the Investigator
Percentage of participants with confirmed CR, PR, or stable disease (SD)
Measured: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 assessed by the Investigator
Percentage of participants with CR, PR or SD ≥16 weeks
Measured: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 assessed by the Investigator
PFS is measured by the time from the first day of study drug administration (Day 1) to the first documentation of disease progression, or to death (due to any cause), whichever occurs first.
Measured: Up to approximately 3 years
Overall Survival (OS)
OS is defined as length of time from the first day of study drug administration (Day 1) to death (due to any cause).
Measured: Up to approximately 3 years
Time to Progression (TTP) per RECIST v1.1 assessed by the Investigator
TTP is defined as the time from first dose of study drug administration until first documentation of disease progression
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start18 Jul 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion28 Feb 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BicycleTx Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933329
- Sponsor's protocol ID
- BT8009-202 (Duravelo-4)
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Zelenectide Pevedotin in Participants With Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06933329
- Acronym / sponsor ID
- BT8009-202 (Duravelo-4)
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NECTIN4, Zelenectide pevedotin, Advanced or Metastatic, NSCLC, Chemotherapy, Non-Squamous, Squamous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- BicycleTx LimitedIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 18 Apr 2025 (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.
This is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated NECTIN4-amplified advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior line of systemic therapy in the advanced/metastatic setting (see inclusion criteria below). The study will comprise of 2 cohorts: Cohort A (non-squamous NSCLC) and Cohort B (squamous NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A (non-squamous NSCLC) | Experimental | Drug: Zelenectide pevedotin |
| Cohort B (squamous NSCLC) | Experimental | Drug: Zelenectide pevedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically or cytologically confirmed advanced or metastatic NSCLC.
- Confirmed NECTIN4 gene amplification by an analytically validated clinical trial assay.
- Participants must have received at least 1 prior line of systemic therapy in the advanced/metastatic setting.
- Measurable disease as defined by RECIST v1.1.
- Adequate archival or fresh tumor tissue comprised of advanced or metastatic NSCLC should be available for submission to central laboratory, if not provided during prescreening.
Key exclusion criteria (13 listed)
- Evidence of mixed small cell lung cancer (SCLC) and NSCLC histology.
- Prior treatment with monomethyl auristatin E (MMAE) (vedotin) based therapy.
- Known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to MMAE.
- Ongoing clinically significant toxicity (Grade ≥ 2) associated with prior treatment for NSCLC (including radiotherapy or surgery), with the exception of well-controlled immuno-oncology related endocrine disorders on supportive or replacement therapy, and alopecia. (Note: Immunosuppressive therapies should be stopped or tapered down to ≤10 mg/day prednisone or equivalent before first study drug administration.)
- Active keratitis or corneal ulcerations.
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 |
|---|---|---|
| Zelenectide pevedotinAlso: BT8009Participants will receive zelenectide pevedotin on Days 1, and 8 of every 21-day cycle. | Drug | Cohort A (non-squamous NSCLC), Cohort B (squamous NSCLC) |
Primary outcome
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator
Time frame: Up to approximately 3 years
Percentage of participants with either a confirmed complete response (CR) or partial response (PR)
7 secondary outcomes
Number of participants reporting adverse events (AEs) and abnormalities in laboratory, electrocardiogram (ECG) and vital signs
Time frame: Up to approximately 3 years
Duration of Response (DOR) per RECIST v1.1 assessed by the Investigator
Time frame: Up to approximately 3 years
Disease Control Rate (DCR) per RECIST v1.1 assessed by the Investigator
Time frame: Up to approximately 3 years
Clinical Benefit Rate (CBR) per RECIST v1.1 assessed by the Investigator
Time frame: Up to approximately 3 years
Progression Free Survival (PFS) per RECIST v1.1 assessed by the Investigator
Time frame: Up to approximately 3 years
Overall Survival (OS)
Time frame: Up to approximately 3 years
Time to Progression (TTP) per RECIST v1.1 assessed by the Investigator
Time frame: Up to approximately 3 years
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zelenectide pevedotin in people with Non-Small Cell Lung Cancer, run by BicycleTx Limited at 3 sites in 2 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 11 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, France. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) assessed by Investigator (time frame: Up to approximately 3 years). 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 15 Apr 2026.