Phase 2 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 between 18 and 75 years, of any gender
• People with a good general health and activity level, able to carry out normal daily activities with little or no limitation (confirmed by a doctor using a standard scale called ECOG 0–1)
• People who have been confirmed through a tissue or cell sample test to have small cell lung cancer (SCLC)
• People whose cancer has been staged as early to locally advanced (Stage I to IIIB, meaning the tumour has not spread to distant parts of the body) and is considered removable or potentially removable by surgery, based on the 8th edition of a standard cancer staging system
• People whose cancer has at least one measurable tumour or affected lymph node visible on a CT scan, meeting specific size requirements
• People who have received no prior treatment for small cell lung cancer — including no radiation, chemotherapy, traditional Chinese medicine, surgery, or targeted therapy
• People whose imaging tests (including PET-CT, CT or ultrasound of the chest and abdomen, MRI of the head, and a bone scan) show no spread of cancer to distant parts of the body
• People whose heart and lung function is strong enough to safely undergo planned lung surgery
• People whose blood test results show no medical reasons to avoid immune checkpoint inhibitor treatment
• People with blood counts, liver function, kidney function, and blood clotting results within the ranges required by the trial (confirmed through blood tests within specific timeframes)
• Women who could become pregnant must have a negative pregnancy blood test within 3 days before starting the study treatment, and must agree to use a highly effective form of contraception during the study and for 3 months after the last dose
• Men with female partners who could become pregnant must either have had a surgical sterilisation procedure or agree to use effective contraception during the study and for 3 months after the last dose
• People who are willing to give written consent to take part, follow the study procedures, and attend follow-up visits

Who may not be able to join:

• People whose cancer has spread to the brain or central nervous system
• People with a history of active autoimmune disease (such as serious lung inflammation, eye inflammation, colitis, hepatitis, thyroid conditions, or heart, kidney, or blood vessel inflammation) — though people with well-controlled underactive thyroid on hormone replacement, or those with vitiligo or childhood asthma fully resolved without ongoing treatment, may still be considered (confirm with trial site)
• People with a weakened immune system due to conditions such as HIV, active hepatitis B, hepatitis C, combined hepatitis B and C infection, or active tuberculosis
• People who have taken immune-suppressing medications within the 14 days before starting the study drug, except for low-dose steroids used through a nasal spray, inhaler, or at a very low daily dose
• People who have received a live vaccine within 4 weeks before starting the study, or who plan to receive one during the study
• People who have had another type of cancer within the past 3 years
• People with a history of, or current evidence of, serious lung conditions such as pulmonary fibrosis, interstitial lung disease, pneumoconiosis, radiation-related lung damage, drug-related lung damage, or severely reduced lung function
• People with high blood pressure that is not well controlled
• People with significant heart conditions, including moderate to severe coronary artery disease, heart attack, certain abnormal heart rhythms, specific electrical abnormalities on a heart tracing, or heart failure that meets certain severity levels (confirm with trial site for specific heart-related details)
• People who have had a serious infection within 4 weeks before starting the study drug, or who have an unexplained high fever (above 38.5°C) at the time of screening or first treatment
• People who have previously received a transplanted organ or bone marrow/stem cells from another person
• Women who are pregnant or breastfeeding, or people of childbearing potential who are unwilling or unable to use effective contraception
• People with a known allergy or intolerance to any of the study drugs (SHR-1316, etoposide, or cisplatin) or their ingredients
• People currently taking part in another clinical trial, or who finished another clinical trial less than 4 weeks ago (or within a specific timeframe related to the previous study drug — confirm with trial site)
• People with a known history of substance, alcohol, or drug misuse
• People with any other condition that the trial doctor believes could affect their safety or ability to follow the study requirements

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