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 diagnosed with non-small cell lung cancer (NSCLC) that is locally advanced (stage IIIB or IIIC), has spread to other parts of the body, or has come back (stage IV), and where surgery and combined radiation plus chemotherapy are not possible
• People aged 18 to 75 years old, of any gender, who are reasonably active and well enough to carry out daily activities (as measured by a standard health score), and whose life expectancy is at least 3 months
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST 1.1)
• People whose cancer got worse after receiving a first course of treatment that included an immune checkpoint inhibitor (a type of immunotherapy targeting PD-1 or PD-L1) combined with platinum-based chemotherapy
• People who can provide tumour tissue samples — either stored samples or samples taken within the 12 months before joining the trial — that have not been treated with radiation (at least 5 sample pieces are needed for testing, though prior test results may be accepted in some cases)
• People whose tumour is not squamous cell type and who have had testing confirming the absence of certain specific gene changes (EGFR mutations, ALK fusion, or ROS1 fusion) — squamous cell NSCLC patients are exempt from this requirement
• People whose major organs (such as liver, kidneys, and heart) are functioning well
• Women who could become pregnant must agree to use effective contraception during the study and for 6 months after it ends, and must have a negative pregnancy test within 7 days before joining; men must also agree to use effective contraception during the study and for 6 months after it ends
• People who are willing to participate voluntarily, sign a consent form, and are likely to follow the study requirements

Who may not be able to join:

• People with brain metastases that do not meet specific criteria around location, size, number, symptoms, and steroid use (confirm with trial site)
• People who have had another active cancer diagnosis within the past 2 years
• People with a specific type of squamous cell lung cancer originating near the main airways that has formed a cavity
• People whose tumour imaging suggests the cancer is growing into or very close to major blood vessels in a way that could cause serious bleeding
• People with severe bone damage from cancer spread to bones — such as fractures of weight-bearing bones or spinal cord compression within the past 6 months, or imaging showing three or more bone metastases in weight-bearing bones
• People with fluid build-up around the lungs, abdomen, or heart that requires repeated draining, or who have had such fluid drained in the 2 weeks before treatment
• People who received certain traditional Chinese medicines with anti-tumour indications within 2 weeks before the study starts
• People who have previously been treated with certain anti-blood vessel growth drugs (such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, or fruquintinib) for advanced NSCLC
• People who have previously received docetaxel chemotherapy for advanced NSCLC
• People who had unacceptable side effects from prior immunotherapy targeting PD-1 or PD-L1
• People who received immune-modifying medications within 30 days before starting treatment
• People who required steroid treatment at a certain dose or other immune-suppressing drugs within 14 days before joining the trial
• People who have not yet recovered from side effects of prior cancer treatments (with some exceptions for hair loss and mild nerve symptoms)
• People with severe liver disease, active hepatitis, or active COVID-19 infection
• People with kidney failure requiring dialysis, or a history of kidney disease such as nephrotic syndrome or chronic nephritis
• People with certain heart or blood vessel conditions (confirm specific details with trial site)
• People who cannot swallow oral medications, have conditions that affect how the gut absorbs medicines, or who have had part of the stomach or intestines removed (other than the appendix)
• People who have been treated for active stomach or intestinal ulcers within the past 6 months
• People with a history of immune system deficiency, including HIV, or other immune disorders; people with active autoimmune diseases such as Crohn's disease, ulcerative colitis, or autoimmune hepatitis; or people who have had or are planned to have an organ transplant
• People with bleeding or clotting disorders, or who have taken blood-thinning or antiplatelet medications (other than low-dose aspirin of 100 mg or less per day) within 28 days before starting treatment
• People who have coughed up blood within 28 days before starting treatment
• People who have had major surgery or a significant injury within 28 days before starting treatment
• People with wounds or fractures that have not healed (excluding cancer-related fractures)
• People with poorly controlled type 1 or type 2 diabetes
• People who have had a severe infection within the past year, or a moderate active infection within 2 weeks before starting treatment, or who test positive for syphilis antibodies, or who have an unexplained fever above 38°C during screening
• People with existing or previous lung conditions such as interstitial lung disease, pneumoconiosis, or significantly reduced lung function confirmed by testing
• People with active tuberculosis within the past year
• People with a history of serious allergic reactions, severe hypersensitivity to other monoclonal antibody treatments, or known allergy to ingredients in the study drug (including Tween 80)
• People with a history of severe mental health disorders
• People with a history of substance, alcohol, or drug misuse
• People who finished a previous clinical trial or received a study drug less than 4 weeks ago (or less than 5 half-lives of that study drug, whichever is shorter)
• People who received a vaccination in the 28 days before joining the trial, or who plan to be vaccinated during the study period
• People who are pregnant or breastfeeding
• People who the trial doctor considers unsuitable for other health or safety reasons

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