NCT07174583

Who might be able to join this trial:

• You are willing to take part, understand what the study involves, and can sign a consent form.
• You have been diagnosed with a specific type of cancer confirmed by a lab test — including advanced small cell lung cancer (SCLC), a cancer type called neuroendocrine carcinoma (NEC), or other tumors that test positive for a protein called DLL3 — and your cancer has come back or gotten worse after standard treatments.
• You have had no more than 2 previous rounds of chemotherapy, and no more than 3 total rounds of cancer treatment for advanced or spread disease.
• You are willing to provide blood or tissue samples for testing.
• You have at least one area of cancer that can be measured on a scan.
• You are relatively active and able to care for yourself, scoring 0 or 1 on a standard activity scale used by doctors (ECOG score).
• Doctors expect you to live for more than 3 months.
• Your bone marrow, liver, kidneys, and other organs are working well enough to safely take part.
• If you are a woman who could become pregnant, you must agree to use very effective birth control from the time you sign the consent form until 8 months after your last dose; if you are a man whose partner could become pregnant, you must use effective birth control until 5 months after your last dose.

Who may not be able to join:

• Your lung cancer is a mixed type combining small cell and non-small cell lung cancer (note: small cell lung cancer with a large cell component may still be eligible — confirm with trial site).
• You have cancer that has spread to the brain or spinal cord and has not been treated with radiation or surgery, or is currently active.
• You have had another type of cancer in the past 2 years, with some exceptions such as certain early-stage or treated skin cancers, cervical or breast cancer in situ, treated prostate cancer with no return, or treated thyroid cancer (confirm with trial site if unsure).
• You have cancer pain that is not being adequately controlled.
• You have serious heart or blood vessel disease.
• You have had significant bleeding in the 3 months before starting the trial.
• You have had a lung condition called interstitial pneumonitis during past treatment, currently have a non-infectious lung inflammation requiring steroid treatment, or have had other serious lung diseases affecting your breathing in the past 3 months.
• You have a weakened immune system or test positive for HIV.
• You have a known or suspected hepatitis B or C infection.
• You have had active tuberculosis (TB) in the past year.
• If you are joining the part of the trial using a drug called durvalumab: you have previously had a moderate-to-severe immune-related side effect from immunotherapy, particularly heart inflammation (myocarditis), unless it has fully or mostly recovered.
• If you are joining the part of the trial using a drug called IDE161: you have had your stomach or part of your small intestine surgically removed, or have a condition affecting how your gut absorbs medicines, such as Crohn's disease or ulcerative colitis.
• You have recently received chemotherapy (within 3 weeks), immunotherapy or biological treatments (within 2 weeks), small molecule drugs (within 2 weeks or 5 half-lives, whichever is longer), or other experimental treatments (within 4 weeks or 5 half-lives, whichever is longer) before starting this trial.
• You are currently taking certain medicines that strongly affect how the body processes drugs (including strong CYP3A4 or CYP2D6 blockers or boosters, or P-gp/BCRP blockers), or medicines known to affect heart rhythm (confirm with trial site for specific drug names).
• If joining the IDE161 part of the trial: you are taking certain other specific medicines including acid-reducing drugs (such as proton pump inhibitors, H2 blockers, or antacids) or drugs that interact with certain proteins in the body (confirm with trial site for details).
• You have previously been treated with a type of therapy called a DLL3 ADC, or any treatment containing a topoisomerase I inhibitor (including certain antibody-drug combinations).
• If joining the durvalumab part of the trial: you previously could not tolerate a type of immunotherapy called a PD-