Phase 2 study for people with Lung Cancer
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Novartis Investigative Site | Clayton | VIC | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
The official eligibility criteria
Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.
Inclusion Criteria:
* Phase I: Patients with ES-SCLC and disease progression after one or more chemotherapy regimens (that included a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor) according to the local SOC (2L+), unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, according to the investigator's judgement. Prior DLL3 (Delta-like ligand 3) targeted therapy is allowed.
* Phase II: Patients with ES-SCLC who have received a platinum-based doublet chemotherapy in combination with a PD-L1 inhibitor according to local standard of care, unless the patient was ineligible to receive such therapies or was not a candidate for any available standard therapy, as determined by the investigator's judgment. Prior DLL-3 targeted therapy is not allowed.
* Male or female patients must be ≥ 18 years of age.
* Histologically or cytologically confirmed small cell lung cancer (SCLC).
* At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patients must have an archival tumor tissue available, collected within 6 months prior to screening. If an archival tumor sample, collected within 6 months prior to screening, is not available, patients must be willing to undergo a new tumor biopsy at screening; , however this specimen need not be collected prior to scheduling leukapheresis. If a new biopsy is not medically feasible, exceptions may be considered after documented discussion with the Novartis medical monitor.
* Patient must be deemed suitable by the investigator to undergo the lymphodepletion (LD) regimen.
* Patient must have an apheresis product of non-mobilized cells accepted for manufacturing.
Exclusion Criteria:
* Prior administration of a genetically modified cellular product, including prior DLL3-targeted CAR-T cell therapy.
* Unstable or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. Stable brain metastases may participate provided they meet the specific criteria.
* Uncontrolled seizure disorder.
* Clinically significant active infections, including Hepatitis B/C and Human Immunodeficiency Virus (HIV).
* Has a known additional malignancy that is progressing or requires active treatment, with specific exceptions as defined in the study protocol.
* History of prior solid organ transplant or allogenic hematopoietic cell transplant
* Other significant pulmonary, cardiac, hepatic, renal or neurologic disease, parameters for which are defined in the study protocol.
* Pregnant or nursing women.
Other protocol-defined inclusion/exclusion criteria may apply.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 11 September 2026.
- This page last checked by Voxsanity: 11 October 2026.
Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.
Not medical advice.
Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.
Letter for your doctor
A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.