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 to 75 years old, of any gender.
• People diagnosed with extensive-stage small cell lung cancer (ES-SCLC) confirmed by a tissue or cell sample, where cancer has spread to no more than 3 organs and no more than 5 lesions in total — including certain cases with brain, bone, adrenal gland, or lymph node involvement.
• People with a general health score of 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light activity (confirm with trial site).
• People who have not previously received any first-line treatment for ES-SCLC or any immune checkpoint therapy.
• People who had surgery in the past without chemotherapy or radiotherapy afterward, and where at least 6 months have passed since any prior chemotherapy or radiotherapy.
• People able to provide a suitable tumour tissue sample — either stored within the last 6 months or freshly collected — that has been prepared in a specific way (fixed in formalin and embedded in paraffin, with at least 10 thin sections available); certain sample types are not accepted (confirm with trial site).
• People with an estimated life expectancy of at least 8 weeks.
• People who have at least one measurable tumour lesion according to standard imaging criteria (RECIST v1.1).
• Women of childbearing age who have a negative blood pregnancy test within 7 days before the first dose, and who agree to use contraception from the time of consent until 24 weeks after the last dose; male participants whose partners could become pregnant must also agree to contraception during this period.
• People whose blood test results before starting the trial meet specific levels for blood cell counts, liver function, kidney function, blood clotting, and certain enzymes (confirm exact values with trial site).
• People who voluntarily agree to join the trial, sign a consent form, and are willing to attend follow-up appointments.

Who may not be able to join:

• People with brain or liver metastases that are causing symptoms.
• People with uncontrolled fluid build-up in body cavities (such as around the heart, lungs, or abdomen) that requires repeated draining.
• People with uncontrolled or symptomatic high calcium levels in the blood.
• People diagnosed with another cancer within the last 5 years before the first dose — with some exceptions, such as certain early-stage or surgically treated cancers (confirm with trial site).
• People with active or known autoimmune diseases (such as lupus, rheumatoid arthritis, or inflammatory bowel disease) — some specific, well-controlled conditions may be considered (confirm with trial site).
• People who have previously received immune checkpoint treatments, such as PD-1, PD-L1, PD-L2, or CTLA-4 inhibitors, or other T cell-targeting therapies.
• People who have used corticosteroids at doses above 10 mg/day of prednisone (or equivalent) or other immune-suppressing medications within 14 days before the first dose — some exceptions apply (confirm with trial site).
• People with active hepatitis B virus (HBV) at levels above the laboratory's normal range, active hepatitis C infection, or a known history of HIV or AIDS.
• People with a history of certain lung conditions such as idiopathic pulmonary fibrosis, drug-related lung inflammation, or active pneumonia — some exceptions may apply (confirm with trial site).
• People with active tuberculosis, or a history of active tuberculosis within the past 48 weeks.
• People who have a serious active infection requiring hospitalisation at the time of enrolment.
• People who have had major surgery within 28 days before joining, or who plan to have major surgery during the trial.
• People who have received a live attenuated vaccine (such as a live flu vaccine) within 28 days before enrolment, or who expect to receive one during the study or within 5 months after the last dose.
• People with serious heart conditions, such as moderate-to-severe heart failure, unstable angina, unstable irregular heartbeat, or a heart attack or stroke within the past 3 months.
• People who have previously received a bone marrow transplant or solid organ transplant.
• People with a known allergy to the trial drugs, their ingredients, any monoclonal antibody, or to carboplatin or etoposide.
• People who have taken part in another experimental drug study or interventional clinical trial within 4 weeks before signing the consent form.
• People who have received systemic immune-suppressing medications within one week before joining — some short-term or inhaled exceptions may apply (confirm with trial site).
• People with known serious mental illness, alcohol dependence, active smoking that cannot be stopped, or drug or substance misuse, or where the treating doctor determines that other factors make participation unsafe or not feasible.

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