Phase 2 Lung Cancer Trial, Recruiting NCT07564401 Sponsor: Novartis Pharmaceuticals Condition: Lung Cancer
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Phase 2 Lung Cancer Trial, Recruiting

NCT07564401
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older.
  • People who have been diagnosed with small cell lung cancer (SCLC) that has spread widely in the body (called extensive-stage SCLC), confirmed through a tissue or cell sample test.
  • For the Phase I part of the trial: People whose cancer has continued to grow or spread after receiving at least one chemotherapy treatment (which included a platinum-based chemotherapy combined with a type of immunotherapy called a PD-L1 inhibitor), unless a doctor determined those treatments were not suitable for them.
  • For the Phase II part of the trial: People who have already received a platinum-based chemotherapy combined with a PD-L1 inhibitor immunotherapy, unless a doctor determined those treatments were not suitable for them. Previous treatment with a DLL3-targeted therapy is not allowed in Phase II (it is allowed in Phase I).
  • People who have at least one area of cancer that can be measured on a scan, as defined by standard medical guidelines.
  • People who are generally well enough to carry out light daily activities (a level rated 0 or 1 on a standard health scale used in cancer research).
  • People who have a tumour tissue sample available from within the past 6 months, or who are willing to have a new tissue biopsy taken at the start of the trial if no recent sample exists (exceptions may be considered if a new biopsy is not medically possible, after discussion with the study medical team).
  • People who a doctor determines are well enough to go through a preparatory treatment process called lymphodepletion.
  • People whose cell collection process (called apheresis) produces a sample that is accepted for use in manufacturing the trial treatment.

Who may not be able to join:

  • People who have previously received any genetically modified cell therapy, including any CAR-T cell therapy that targeted DLL3.
  • People with brain or spinal fluid involvement from their cancer that is unstable or causing symptoms (people with stable brain spread may still be considered if they meet specific study requirements — confirm with trial site).
  • People with seizures that are not well controlled.
  • People with serious active infections, including active Hepatitis B, Hepatitis C, or HIV.
  • People who have another cancer that is currently growing or requires ongoing treatment, with some exceptions as outlined in the study details (confirm with trial site).
  • People who have previously had an organ transplant or a bone marrow/stem cell transplant from another person.
  • People with significant existing problems affecting the lungs, heart, liver, kidneys, or nervous system, as defined by specific measurements in the study guidelines (confirm with trial site).
  • People who are pregnant or currently breastfeeding.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-888-669-6682

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
16 June 2026
Est. completion
3 March 2031

Where this trial is recruiting

🇸🇬 Singapore 🇺🇸 United States

Primary endpoints

All study parts: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); All study parts: Incidence and severity of dose-limiting toxicities (DLTs); Phase II Group A: Overall response rate (ORR) as per RECIST v1.1

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov