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:

• Adults aged 18 or older (or the legal age of consent in their country, if higher) who have agreed to take part by signing a consent form.
• People with a laboratory-confirmed diagnosis of one of the following cancer types: small cell lung cancer (SCLC), a type of cancer called extra-pulmonary neuroendocrine carcinoma (epNEC, excluding certain subtypes), or large cell neuroendocrine carcinoma of the lung (LCNEC). For tumours with mixed cell types, the neuroendocrine or small cell component must make up at least 50% of the tumour.
• People whose cancer has come back or continued to grow after standard treatments — for SCLC, this means after at least two prior treatment regimens including at least one platinum-based chemotherapy (and a PD-L1 immunotherapy combination, where that is standard care); for epNEC or LCNEC, after at least one platinum-based chemotherapy.
• People in Parts 2 and 3 of the trial whose epNEC cancer has been confirmed to have high levels of a protein called DLL3, as assessed by a central laboratory, and whose cancer progressed after at least one platinum-based chemotherapy.
• People who are reasonably well and able to carry out daily activities, as measured by a standard performance scale (score of 0 or 1 on the ECOG scale).
• People who have at least one measurable area of cancer, assessed within 21 days before the first dose of the trial drug.
• People who can provide a stored tumour tissue sample from a previous biopsy or surgery (for Parts 2 and 3, this must be a specific type of preserved tissue sample — certain sample types such as fine needle aspirations or bone samples are not accepted).
• People whose organs (such as liver, kidneys, and bone marrow) are functioning adequately, as defined in the trial protocol.
• People whose side effects from previous cancer treatments have largely resolved to a mild level before starting the trial drug, with some specific exceptions allowed at a slightly higher level (confirm with trial site).
• People who are able and willing to use highly effective contraception during the trial, as specified in the trial guidelines — this applies to women who could become pregnant and to men who could father a child.
• For Part 3 only (at a specific screening stage): people who are willing to stay within one hour's drive of the trial site for 48 hours after receiving the trial drug, and who have a carer available during that time. People who are considered by the trial doctor to be capable of following home-monitoring instructions, such as taking their own temperature and taking oral medicines at home if needed.

Who may not be able to join:

• People with untreated or currently symptomatic brain metastases (cancer that has spread to the brain). People with brain metastases that have been treated and are stable may still be considered, provided treatment finished at least 2 weeks before the trial drug, and steroid or anti-epileptic medicines have been stopped or stabilised for at least 7 days (confirm with trial site).
• People with cancer that has spread to the lining around the brain or spinal cord (leptomeningeal disease), or — in Parts 2 and 3 — cancer pressing on the spinal cord or surrounding it.
• People with a current or past history of certain lung conditions, including scarring of the lung tissue or non-infection-related lung inflammation (for Parts 2 and 3, this also includes pulmonary fibrosis and organising pneumonia). People whose lung inflammation was caused by a previous therapy and is considered fully resolved may still be considered (confirm with trial site).
• People who have previously had a severe or life-threatening immune reaction, or a serious reaction to an infusion, while receiving an immunotherapy (immuno-oncology) treatment — particularly if that reaction led to permanently stopping the treatment.
• People who have received any other anti-cancer treatment within 4 weeks (or within 5 half-lives of that drug, whichever is shorter) before the first dose of the trial drug.
• People who have received wide-field radiotherapy (including whole-brain radiation) within 2 weeks before the first dose of the trial drug.
• People who have previously been treated with a therapy that targets the DLL3 protein using T cell engager drugs or cell-based therapies.
• People who have a condition that weakens the immune system, or who have received steroid or immunosuppressive treatment within 7 days before the first dose (normal replacement doses of steroids are permitted).
• People who still have unresolved significant side effects from previous cancer treatments (as described in the inclusion criteria above).
• Additional exclusion criteria apply that are not listed here — the trial site can provide the full list.

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