Phase 2 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:

• People aged 18 or older (or the minimum legal adult age, whichever is higher) at the time of signing the consent form.
• People who have been diagnosed with extensive-stage small cell lung cancer (ES-SCLC), confirmed through a tissue or cell sample test.
• For Group 1 (Cohort 1): People who have already completed 4 treatment cycles with carboplatin, etoposide, and atezolizumab for ES-SCLC, and whose cancer is stable or responding to treatment.
• For Group 2 (Cohort 2): People who have not yet received any treatment for ES-SCLC.
• For Group 2 only: People who have at least one area of cancer that can be measured on a CT or MRI scan.
• For Group 2 only: People who have at least one area of cancer that can be safely biopsied, and who agree to provide a tissue sample before and during treatment.
• People who are in good enough general physical condition to carry out normal daily activities with little or no limitation (confirm with trial site for exact fitness level required).
• People whose organs (such as liver, kidneys, and bone marrow) are functioning adequately, as confirmed by recent tests.
• Women who could become pregnant must not be currently pregnant or breastfeeding, and must agree to use highly effective contraception and not donate or freeze eggs during treatment and for a set period afterwards.
• Men who can father children must agree to use effective contraception and not donate sperm during treatment and for a set period afterwards.
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests and procedures.

Who may not be able to join:

• People who have previously been treated with certain targeted drugs known as B7-H3 agents, including orlotamab, enoblituzumab, or the study drug I-DXd.
• People who previously had to stop a similar type of drug (called an ADC containing an exatecan derivative, such as trastuzumab deruxtecan) because of serious side effects.
• People who have previously been treated with certain immune-boosting therapies (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs), except for atezolizumab in Group 1.
• People who have not waited long enough after their last treatment before joining the trial (confirm with trial site for specific timeframes).
• People who have had a stroke, mini-stroke, or another blood clot in an artery in the past 6 months.
• People who have active, symptomatic cancer spread to the brain or spinal cord, or who need steroids or anti-seizure medication to manage these symptoms.
• People with significant corneal (eye surface) disease.
• People with uncontrolled or serious heart or blood vessel disease.
• People who have previously had serious lung inflammation (ILD/pneumonitis) that needed steroid treatment, or who currently have or are suspected to have this condition.
• People with serious breathing problems caused by other lung conditions.
• People who are currently taking ongoing steroid medication at a dose of 10 mg or more of prednisone (or equivalent) per day, unless it is a low-dose inhaled, topical, or joint-injection steroid.
• People who have had another type of cancer in the past 5 years, with some exceptions such as certain treated skin cancers, early-stage cancers that were fully treated, or some bladder cancers removed by surgery (confirm with trial site).
• People who have had a bone marrow, stem cell, or solid organ transplant from another person.
• People who still have unresolved side effects from previous cancer treatments (other than hair loss) that have not returned to a mild or baseline level.
• People with a known allergy or severe reaction to any of the study drugs or their ingredients, or to similar types of medications.
• People with an active, uncontrolled bacterial, fungal, or viral infection.
• People with active or uncontrolled HIV infection.
• People with active or uncontrolled hepatitis B or C infection.
• People with a history of autoimmune disease.
• People with severe or uncontrolled serious illness.
• People who have received a live vaccine within 30 days before the first dose of the study drug.
• Women who are pregnant, breastfeeding, or planning to become pregnant.
• People with any other medical, psychological, social, or practical circumstances that, in the treating doctor's opinion, could affect safety or the reliability of study results.
• People with personal, family, or logistical circumstances that would make regular follow-up difficult.

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