Small Cell Lung CarcinomaPhase 1NCT07006727
Phase I Study of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
A Phase 1 study testing 225Ac-ETN029 and 111In-ETN029 in people with Small Cell Lung Carcinoma and Large Cell Neuroendocrine Carcinoma of the Lung, run by Novartis Pharmaceuticals at 8 sites in 4 countries.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging properties of [111In]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung, Neuroendocrine Prostate Cancer
- What is being tested?
- 225Ac-ETN029 and 111In-ETN029
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 16 Oct 2025to 29 Aug 2031
- Phase
- Phase 1
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Patients with one of the following indications:
- Dose Escalation Only:
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy (prior DLL3-targeted therapy allowed).
- LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy.
- Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) confirmed by local histopathology, for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment. Prior RLT is not allowed, though exceptions can be made following discussion with Novartis Medical Monitor.
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- Locally advanced, unresectable, or metastatic GEP-NEC, cervical NEC, genitourinary NEC, thymic NEC, Merkel cell carcinoma, or unknown primary NEC with disease progression following, or intolerance to, at least one line of systemic therapy (including platinum-containing chemotherapy for non-MCC indications, or PD-1 or PD-L1 inhibition for MCC, unless patient was ineligible to receive such therapy), and for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment.
- Locally advanced, unresectable, or metastatic medullary thyroid cancer with disease progression following, or intolerance to, at least 1 line of systemic therapy (unless patient was ineligible to receive such therapy), and for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment.
- Dose expansion only:
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy (prior DLL3-targeted therapy allowed). Patients should have received no more than 2 prior lines of systemic therapy.
- Locally advanced, unresectable, or metastatic GEP-NEC, with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum containing chemotherapy. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator.
- Locally advanced, unresectable, or metastatic de novo or castration-resistant, treatment emergent NEPC with neuroendocrine differentiation confirmed by local histology and NEPC marker expression (e.g., chromogranin, synaptophysin) confirmed by local IHC. Prior PSMA-targeted, Lu-177-based RLT is allowed. Patients must have at least one measurable lesion (per RECIST 1.1) that shows 111In-ETN029 uptake higher than surrounding tissues on SPECT/CT as assessed by the Investigator.
Who cannot join
- Absolute neutrophil count (ANC) < 1.0 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 75 x 10^9/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR < 60 mL/min/1.73m2 calculated using the CKD-EPI 2021 formula or measured
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of leptomeningeal disease, of symptomatic CNS metastases or of CNS metastases that require local CNS-directed therapy
- History of or current interstitial lung disease or pneumonitis ≥ Grade 2
Show all 9Show fewer
- Any prior DLL3-targeted therapy (except for SCLC)
- Any prior RLT (except for NEPC patients in expansion)
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 4 countries
United States4 sites, 4 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beatrice Sears, bmsears@mgh.havard.edu
Shadi Abdar Esfahani
- Recruiting
University Of Iowa
Iowa City, Iowa, 52242
Kellie Bodeker, +1 319 356 2197, kellie-bodeker@uiowa.edu
Yusuf Menda
- Recruiting
Corewell Health William Beaum Hosp
Royal Oak, Michigan, 48073-6769
Matthew Johnson, +1 248 898 2697, matthew.johnson3@corewellhealth.org
Andrew Thompson
- Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Heather White, hwhite@fredhutch.org
Delphine Chen
South Korea2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
- Recruiting
Novartis Investigative Site
Seoul, 03722
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Japan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Chuo Ku, Tokyo, 1040045
About this study
Official title: A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging properties of [111In]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers.
Read the detailed description
This is a phase I, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of 225Ac-ETN029 in patients with advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) of 225Ac-ETN029 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of 225Ac-ETN029. The study will also enable an initial evaluation of the safety, dosimetry, PK, and imaging properties of 111In-ETN029.
- Conditions
- Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung, Neuroendocrine Prostate Cancer, Gastroenteropancreatic Neuroendocrine Carcinoma, Non-prostate Extrapulmonary Neuroendocrine Carcinoma, Cervical Neuroendocrine Carcinoma
- Being tested
- 225Ac-ETN029, 111In-ETN029
- Keywords
- Small Cell Lung Carcinoma (SCLC), Large Cell Neuroendocrine Carcinoma of the Lung (LCNEC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), Cervical Neuroendocrine Carcinoma, Thymic Neuroendocrine Carcinoma, Genitourinary Neuroendocrine Carcinoma (GU-NEC), Unknown Primary Neuroendocrine Carcinomas, Merkel cell carcinoma (MCC), Medullary thyroid carcinoma (MTC), DLL3, Neuroendocrine neoplasms, Radioligand therapy (RLT), [225Ac]Ac-ETN029, [111In]In-ETN029
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Merkel Cell, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
225Ac-ETN029Drug
Radioligand therapy
111In-ETN029Drug
Radioligand imaging agent
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029 Receives: Drug: 225Ac-ETN029; Drug: 111In-ETN029 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicities of 225Ac-ETN029
A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE 5.0 grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.
Measured: From the start of study treatment until 6 weeks after
Incidence and severity of adverse events and serious adverse events of 225Ac-ETN029
Incidence and severity of treatment-emergent adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs
Measured: From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months
Dose modifications for 225Ac-ETN029
Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029
Measured: From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks
Dose intensity for 225Ac-ETN029
Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure
Measured: From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks
Secondary outcomes (13)
Overall response rate (ORR)
ORR is defined as the proportion of patients with a BOR of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines.
Measured: Up to approximately 42 months
Disease control rate (DCR)
DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease according to RECIST v1.1 guidelines.
Measured: Up to approximately 42 months
Duration of response (DOR)
DOR is defined as the time between the first documented response (CR or PR) and the date of progression according to RECIST v1.1 guidelines, or death due to any cause.
Measured: Up to approximately 42 months
Progression free survival (PFS)
PFS is defined as the time from the date of start of treatment to the date of the first documented progression according to RECIST v1.1 guidelines or death due to any cause.
Measured: Up to approximately 42 months
Area under the curve (AUC) of 225Ac-ETN029 and 111In-ETN029
Area under the concentration time curve. AUC is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Observed maximum blood concentration (Cmax) of 225Ac-ETN029 and 111In-ETN029
The maximum (peak) observed blood drug concentration after single dose administration. Cmax is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Volume of distribution (Vz) of 225Ac-ETN029 and 111In-ETN029 during the terminal phase
The apparent volume of distribution during terminal phase. Vz is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Terminal elimination half-life (T1/2) of 225Ac-ETN029 and 111In-ETN029
The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve. T1/2 (associated with a terminal slope) is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Total body clearance of 225Ac-ETN029 and 111In-ETN029
The total body clearance of drug from the plasma. Clearance is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Observed maximum radioactivity concentration (Rmax) of 225Ac-ETN029
The maximum (peak) observed blood radioactivity concentration after single dose administration. Rmax is a PK parameter that will be determined using non-compartmental analysis (NCA).
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Absorbed dose of 225Ac-ETN029 and 111In-ETN029
The absorbed dose will be determined based on time activity curves (TACs) obtained from the radiotracer uptake (as percentage of injected dose) via quantification of images.
Measured: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Incidence and severity of adverse events and serious adverse events of 111In-ETN029
Incidence and severity of treatment-emergent adverse events and serious adverse events
Measured: From the start of 111In-ETN029 to the day before the first 225Ac-ETN029 administration or until the completion of 30 day follow up (assessed as approximately 30 days)
Visual and quantitative assessment of 111In-ETN029 uptake in normal tissues over time
Quantitative assessment expressed as standardized uptake values (SUVs) of 111In-ETN029 uptake in normal tissues
Measured: During the first ~5 days following 111In-ETN029 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start16 Oct 2025
- Primary completion29 Aug 2031 (estimated)
- Study completion29 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006727
- Sponsor's protocol ID
- CESP359A12101
- Other IDs
- 2024-519111-34-00
- Status last verified
- Sep 2026
- First submitted
- 16 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [225Ac]Ac-ETN029 in Patients With Advanced DLL3-expressing Solid Tumors
- ClinicalTrials.gov ID
- NCT07006727
- Acronym / sponsor ID
- CESP359A12101
- Conditions
- Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung, Neuroendocrine Prostate Cancer, Gastroenteropancreatic Neuroendocrine Carcinoma, Non-prostate Extrapulmonary Neuroendocrine Carcinoma, Cervical Neuroendocrine Carcinoma
- Keywords
- Small Cell Lung Carcinoma (SCLC), Large Cell Neuroendocrine Carcinoma of the Lung (LCNEC), Neuroendocrine Prostate Cancer (NEPC), Gastroenteropancreatic Neuroendocrine Carcinoma (GEP-NEC), Cervical Neuroendocrine Carcinoma, Thymic Neuroendocrine Carcinoma, Genitourinary Neuroendocrine Carcinoma (GU-NEC), Unknown Primary Neuroendocrine Carcinomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 29 Aug 2031 (estimated)
- Study completion
- 29 Aug 2031 (estimated)
- First posted
- 5 Jun 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.
The purpose of this study is to evaluate the safety, tolerability, dosimetry and preliminary efficacy of [225Ac]Ac-ETN029 and the safety and imaging properties of [111In]In-ETN029 in patients aged ≥ 18 years with locally advanced or metastatic DLL3 positive cancers.
Detailed description
This is a phase I, open-label, multi-center study to evaluate the safety, tolerability, dosimetry, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of 225Ac-ETN029 in patients with advanced DLL3-expressing solid tumors. The study consists of a dose escalation part, followed by a dose expansion part. Once the recommended radioactive dose(s) of 225Ac-ETN029 for further clinical evaluation are determined, the dose expansion part will further characterize the safety, tolerability, and preliminary anti-tumor activity of 225Ac-ETN029. The study will also enable an initial evaluation of the safety, dosimetry, PK, and imaging properties of 111In-ETN029.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: 225Ac-ETN029, Drug: 111In-ETN029Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old
- Patients with one of the following indications:
- Locally advanced, unresectable, or metastatic SCLC with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy (prior DLL3-targeted therapy allowed).
- LCNEC of the lung with disease progression following, or intolerance to, at least 1 line of systemic therapy, including platinum-containing chemotherapy.
- Metastatic de novo or treatment-emergent neuroendocrine prostate cancer (NEPC) confirmed by local histopathology, for whom no standard therapy is available, tolerated, or appropriate, in the investigator's judgment. Prior RLT is not allowed, though exceptions can be made following discussion with Novartis Medical Monitor.
Key exclusion criteria (9 listed)
- Absolute neutrophil count (ANC) < 1.0 x 10^9/L, hemoglobin < 9 g/dL, or platelet count < 75 x 10^9/L
- QT interval corrected by Fridericia's formula (QTcF) ≥ 470 msec
- eGFR < 60 mL/min/1.73m2 calculated using the CKD-EPI 2021 formula or measured
- Unmanageable urinary tract obstruction or urinary incontinence
- Presence of leptomeningeal disease, of symptomatic CNS metastases or of CNS metastases that require local CNS-directed therapy
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 |
|---|---|---|
| 225Ac-ETN029Radioligand therapy | Drug | Arm 1 |
| 111In-ETN029Radioligand imaging agent | Drug | Arm 1 |
Primary outcome
Number of patients with dose limiting toxicities of 225Ac-ETN029
Time frame: From the start of study treatment until 6 weeks after
A dose limiting toxicity (DLT) is defined as any adverse event or abnormal laboratory value of CTCAE 5.0 grade 3 or higher that occurs within the DLT evaluation period and that is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications with a few exceptions defined in the study protocol. Other significant toxicities may be considered to be DLTs, even if not Grade 3 or higher.
Incidence and severity of adverse events and serious adverse events of 225Ac-ETN029
Time frame: From start of study treatment until completion of the 36 month follow up, assessed up to approximately 42 months
Incidence and severity of treatment-emergent adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs
Dose modifications for 225Ac-ETN029
Time frame: From the start of study treatment until last dose of study treatment, assessed as approximately 24 weeks
Number of dose modifications (e.g, dose interruptions and reductions) for 225Ac-ETN029
Dose intensity for 225Ac-ETN029
Time frame: From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks
Dose intensity of 225Ac-ETN029 defined as the ratio of actual cumulative dose received and actual duration of exposure
13 secondary outcomes
Overall response rate (ORR)
Time frame: Up to approximately 42 months
Disease control rate (DCR)
Time frame: Up to approximately 42 months
Duration of response (DOR)
Time frame: Up to approximately 42 months
Progression free survival (PFS)
Time frame: Up to approximately 42 months
Area under the curve (AUC) of 225Ac-ETN029 and 111In-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Observed maximum blood concentration (Cmax) of 225Ac-ETN029 and 111In-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Volume of distribution (Vz) of 225Ac-ETN029 and 111In-ETN029 during the terminal phase
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Terminal elimination half-life (T1/2) of 225Ac-ETN029 and 111In-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Total body clearance of 225Ac-ETN029 and 111In-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Observed maximum radioactivity concentration (Rmax) of 225Ac-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Absorbed dose of 225Ac-ETN029 and 111In-ETN029
Time frame: During the first ~14 days following 225Ac-ETN029 administration and ~5 days following 111In-ETN029 administration
Incidence and severity of adverse events and serious adverse events of 111In-ETN029
Time frame: From the start of 111In-ETN029 to the day before the first 225Ac-ETN029 administration or until the completion of 30 day follow up (assessed as approximately 30 days)
Visual and quantitative assessment of 111In-ETN029 uptake in normal tissues over time
Time frame: During the first ~5 days following 111In-ETN029 administration
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 22 Sep 2026.
- Individual participant dataSharing planned: No. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 225Ac-ETN029 and 111In-ETN029 in people with Small Cell Lung Carcinoma and Large Cell Neuroendocrine Carcinoma of the Lung, run by Novartis Pharmaceuticals at 8 sites in 4 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 12 inclusion and 9 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 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, South Korea, Canada, Japan. 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 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.
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 Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicities of 225Ac-ETN029 (time frame: From the start of study treatment until 6 weeks after). The study lists 4 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 22 Sep 2026.