Phase 1 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 who have been diagnosed with small cell lung cancer (SCLC) confirmed by a tissue or cell sample, whose cancer has come back or stopped responding to treatment after one previous chemotherapy regimen containing platinum.
• People who are able to provide enough tumour tissue (either fresh or preserved samples).
• People aged 18 to 70 years (inclusive), of any gender.
• People whose general physical ability to carry out daily activities is rated at 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity only).
• People whose life expectancy is estimated to be at least 3 months.
• People who have at least one measurable area of cancer outside the brain, meeting standard measurement criteria; if a tumour was previously treated with radiotherapy, it must be confirmed to have grown back or worsened since then.
• People who were originally diagnosed at an early stage of SCLC and either completed intensive chest radiotherapy at least 1 month before entering the trial, or were unable to have that radiotherapy for specific reasons; if radiotherapy was given for brain metastases, at least 1 month must have passed since it ended.
• People whose screening blood tests show negative results for HIV, hepatitis B surface antigen, hepatitis C, and syphilis (if a specific hepatitis B antibody is positive, an additional hepatitis B DNA test is required, and people whose result falls below a reference level may still be eligible — confirm with trial site).
• People who agree to use effective contraception from the time of signing the consent form until 6 months after the last treatment infusion (applies to people of reproductive age and their partners).

Who may not be able to join:

• People who have a tumour originating in the brain or spinal cord, cancer that has spread to the membranes surrounding the brain, or brain metastases that are unstable (causing symptoms, requiring steroid treatment within 4 weeks before the study treatment, or without imaging evidence of stability for more than 4 weeks).
• People who had a major surgical procedure (other than for diagnosis) within 4 weeks before the blood collection step, or who are expected to need major surgery during the study.
• People who received Chinese herbal medicine or traditional Chinese patent medicine for cancer treatment within 7 days before the blood collection step.
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, certain types of airway inflammation, or drug-related or unexplained lung inflammation; or people whose chest CT scan at screening shows signs of active lung inflammation (note: a history of radiation-related lung scarring in a previously treated area may not be disqualifying — confirm with trial site).
• People who have fluid build-up around the lungs, heart, or abdomen that is poorly controlled and requires drainage more than once a month.
• People with poorly controlled or symptomatic abnormally high calcium levels in the blood (above specified thresholds — confirm with trial site).
• People with active or past autoimmune diseases or immune system deficiencies, including conditions such as myasthenia gravis, muscle inflammation, autoimmune hepatitis, lupus, or rheumatoid arthritis (among others).
• People who had a serious infection within 4 weeks before the blood collection step, including hospitalisation due to infection, blood infection, severe pneumonia, or any active infection that could affect safety.
• People with serious heart or stroke-related conditions, unstable heart rhythm, or unstable chest pain (angina) occurring within 3 months before the blood collection step; or people with a heart function rating of New York Heart Association class II or above.
• People who have previously been treated with drugs targeting a protein called DLL3, or who have previously received CAR-T cell therapy or any other gene-modified T cell treatment.
• People who received another experimental drug within 28 days before the blood collection step.
• People with a history of mental illness.
• People who are unable to make decisions for themselves or whose legal capacity is limited.
• People who are pregnant or breastfeeding; people of childbearing potential who are unwilling to use adequate contraception; people who are able to become pregnant will need to undergo pregnancy testing during the screening period.

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