A Phase 1 interventional study of 225Ac-ETN029 and 111In-ETN029 in Small Cell Lung Carcinoma, Large Cell Neuroendocrine Carcinoma of the Lung and Neuroendocrine Prostate Cancer, sponsored by Novartis Pharmaceuticals. Recruiting at 8 sites in 4 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 1, Interventional, and Treatment
Among 14 studies in Small Cell Lung Carcinoma by Novartis — 4 open to participants now, 5 under way, none of them phase 3. Small Cell Lung Carcinoma · Novartis.
Among the 14 studies in Small Cell Lung Carcinoma by Novartis, this one is the 6th largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2025, is one of 5 in phase 1, and was the 12th registered.
1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 365 are open to participants now.
Browse Small Cell Lung Carcinoma studies →4 of the 14 studies in Small Cell Lung Carcinoma by Novartis are open now, in 12 countries. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in United States, Australia, Singapore and 1 more country
Ages 18+
Novartis Pharmaceuticals · Sites in United States, Australia, Canada and 13 more countries
Ages 18–100
Novartis Pharmaceuticals
Ages 18+
By country, each count listing its studies:
Of the 263 Small Cell Lung Carcinoma studies recruiting now, 173 (66%) set no upper age limit and 66 (25%) stop at 75 or younger; 3 take children under 18; 8 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 7 · Phase 3 1
First in 1998; this study’s year is marked. 2 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 116 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.
Median enrollment 80 across the 13 interventional studies. Of the 8 that completed or were terminated, 2 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 14 studies in Small Cell Lung Carcinoma by Novartis, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Dose Escalation Only:
Dose expansion only:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 225Ac-ETN029, with some patients also receiving 111In-ETN029
Drug: 225Ac-ETN029 · Drug: 111In-ETN029
Radioligand therapy
Radioligand imaging agent
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From start of study treatment until last dose of study treatment, assessed as approximately 24 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
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).
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
The apparent volume of distribution during terminal phase. Vz is a PK parameter that will be determined using non-compartmental analysis (NCA).
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
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).
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
The total body clearance of drug from the plasma. Clearance is a PK parameter that will be determined using non-compartmental analysis (NCA).
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
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).
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
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.
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
Incidence and severity of treatment-emergent adverse events and serious adverse events
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
Quantitative assessment expressed as standardized uptake values (SUVs) of 111In-ETN029 uptake in normal tissues
Time frame: During the first ~5 days following 111In-ETN029 administration
Plan to share: 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.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Aug 2031, 70 months after the start.
Of 111 industry-sponsored phase 1 interventional studies under Small Cell Lung Carcinoma, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 63. This study's planned 70 months is above that.
Counting every sponsor, half of 143 studies reached it within 46 months; a quarter within 29 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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