NCT04878016

Who might be able to join this trial:

• You are 18 years of age or older (any gender)
• You have been diagnosed with Small Cell Lung Cancer (SCLC) confirmed by a tissue or cell sample test
• Your SCLC is at an advanced (extensive) stage, meaning it has spread significantly
• You have not yet received any first-line (initial) treatment for your advanced SCLC
• If you had previous surgery or treatments aimed at curing an earlier cancer, at least 6 months must have passed since your last chemotherapy or radiation before your advanced SCLC was diagnosed
• You are generally able to carry out daily activities with little to no limitation (your doctor will assess this)
• Your doctors estimate you are likely to survive at least 8 weeks
• A CT or MRI scan taken within the last 28 days shows at least one measurable tumor
• You are willing and able to use effective contraception for the duration of the study and for 6 months after the last dose; women of childbearing age must have a negative pregnancy test within 7 days before starting treatment
• Your blood, liver, kidney, and clotting function results meet specific healthy ranges before starting treatment (your doctor will check these with blood tests)
• You are able to provide a tumor tissue sample within about 4 weeks of joining, so researchers can test it for a protein called PD-L1
• You are willing to give your informed consent, follow the study requirements, and attend follow-up appointments

Who may not be able to join:

• You have previously been treated with certain types of immune therapy drugs, such as checkpoint inhibitors (e.g. PD-1, PD-L1, or CTLA-4 blockers), or anti-blood vessel growth (anti-VEGF/VEGFR) treatments
• You currently have active cancer spread to the brain or the lining around the brain that has not been treated — treated brain metastases may be acceptable if certain conditions are met (confirm with trial site)
• You had radiation therapy to the brain or bones fewer than 7 days before starting the study drug
• You have an active autoimmune disease (a condition where your immune system attacks your own body), such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease — some well-controlled conditions like thyroid disease or type 1 diabetes may still be eligible (confirm with trial site)
• You have fluid build-up in your chest, around your heart, or in your abdomen that needs to be drained regularly (more than once a month), unless you have a permanent drainage tube in place
• You have taken steroid medications (above a low dose) or other immune-suppressing drugs within the 14 days before starting the study — some exceptions may apply (confirm with trial site)
• You have received or are planning to receive a live vaccine within 4 weeks before starting the study drug
• You have had major surgery within 4 weeks before starting the study, or major surgery is planned during the study
• You have a lung condition called interstitial lung disease, drug-related lung inflammation, or radiation-related lung inflammation that requires steroid treatment, or you have active pneumonia with symptoms
• You have active tuberculosis or had active tuberculosis within the past year
• You have serious uncontrolled heart problems, such as significant heart failure, unstable chest pain, a heart attack or stroke within the last 6 months, or serious heart rhythm problems needing treatment
• You have an active, uncontrolled infection currently requiring intravenous (IV) antibiotics, antifungals, or antiviral treatment
• You have active hepatitis B, active hepatitis C (unless virus levels are undetectable after treatment), or are HIV-positive or have AIDS — some exceptions may apply (confirm with trial site)
• You have a known allergy to the study drugs or their ingredients, or a history of severe reactions to any similar antibody-based treatment, or allergies to carboplatin or etoposide
• You have previously had a bone marrow transplant or an organ transplant from another person
• You have had another type of cancer within the last 5 years — some fully treated, low-risk cancers (such as certain skin cancers or early-stage prostate cancer) may be exceptions (confirm with trial site)
• You have taken part in another experimental drug trial within 4 weeks before signing up for this study
• You are currently pregnant