Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have been diagnosed with extensive-stage small cell lung cancer (SCLC), confirmed by a tissue sample (biopsy).
• You have already received a first treatment that included platinum-based chemotherapy and immunotherapy, and your cancer came back within 6 months of finishing it.
• If a treatment called tarlatamab was available and appropriate for you, you must have also tried and stopped that treatment before joining.
• You have had no more than 3 total previous cancer treatments overall.
• Your cancer has gotten worse since your most recent treatment, and it can be measured on a scan.
• You are well enough to carry out some daily activities — rated 0, 1, or 2 on a standard doctors' scale of physical wellbeing (confirm with trial site).
• At least 2 weeks (or a certain number of half-lives of the drug, whichever is longer) have passed since your last cancer treatment.
• Any side effects from previous treatments have mostly cleared up, apart from hair loss.
• You are willing and able to use highly effective birth control or completely avoid sex during the study.
• You are able to swallow capsules whole, without chewing, crushing, or opening them.

Who may not be able to join:

• You are currently taking part in another clinical trial that involves a treatment.
• You are currently receiving any other cancer treatments or using cancer-related devices.
• You have had major surgery (unrelated to your SCLC) within the 4 weeks before starting the study.
• You have previously received large-area radiation therapy that affected 20% or more of your bone marrow.
• Your SCLC originally started as a different type of lung cancer or as a mixed type (confirm with trial site).
• You have an uncontrolled nerve or muscle condition linked to your cancer (called a paraneoplastic syndrome) that required new or changed treatment in the 14 days before joining.
• You are taking blood thinners at a full dose, unless your blood clotting levels are within a safe range and your dose has been stable for at least 2 weeks.
• You are taking certain medications that are processed by specific liver enzymes (CYP2D6 and CYP2C19) and cannot be switched to a different medication (confirm with trial site).
• You are taking immune-suppressing medications (such as steroids above a low dose, cyclosporine, or tacrolimus) or received radiation therapy within the 28 days before starting the study.
• You are currently breastfeeding or plan to breastfeed during the study or within 3 months after finishing treatment.
• You have a known allergy to any ingredient in the study drug (NMS-03305293) or in temozolomide.
• You have a serious, active infection — such as a bacterial, fungal, or viral infection — that is not under control, including HIV (unless HIV has been undetectable on treatment for more than 6 months), hepatitis B, or hepatitis C.
• You have a heart condition involving an abnormal heart rhythm (specifically a prolonged QTc interval), uncontrolled heart failure, very low potassium levels, or a personal or family history of certain heart rhythm problems.
• You have an active stomach or intestinal condition (such as ulcers, Crohn's disease, or ulcerative colitis) or any condition that affects how your body absorbs medication.
• You have experienced a heart attack, unstable chest pain, heart bypass surgery, stroke, blood clots in the lungs or legs, active bleeding disorder, or serious lung disease in the past 6 months.
• You have a personal or family history of long QT syndrome or related sudden cardiac death syndromes.
• You have another active cancer, with the exception of certain treated skin cancers, early-stage cervical cancer treated with curative intent, or superficial bladder cancer.
• You have brain or nervous system involvement from your cancer that is causing symptoms or has not been treated, unless it is stable and well controlled with no neurological symptoms (and any steroids used for this have been at a stable dose for at least 14 days).
• You have any other serious medical, mental health, or laboratory condition that the trial doctor believes would make it unsafe or unsuitable for you to participate.

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