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 who are willing to volunteer to take part in a clinical study.
• People aged 18 to 75 years old at the time of signing the consent form.
• People who can provide a pathology report and genetic test report from before their cancer changed type, clearly showing they had non-small cell lung cancer with an EGFR mutation before the change.
• People who can provide a pathology report from after their cancer changed type, along with 10 unstained tissue samples, showing the cancer changed to small cell lung cancer, high-grade neuroendocrine carcinoma, or a cancer containing small cell lung cancer components.
• People who have not received systemic cancer treatment or certain immunotherapy drugs (anti-PD-1/L1 or CTLA-4 therapies) after their cancer changed type. Immunotherapy received before the cancer changed type may be acceptable, but the most recent treatment before joining cannot have included immunotherapy.
• People whose previous cancer treatment ended more than 2 weeks before starting this trial, and whose treatment side effects have largely resolved (confirm with trial site for specific grading details), except for a certain level of hair loss.
• People who have at least one measurable area of cancer, as identified by scans within the four weeks before starting treatment.
• People with a good general health and activity level, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of at least 12 weeks.
• People whose liver, kidneys, and other organs are functioning well enough to meet the trial's requirements (confirm with trial site for specific lab values).
• Female patients whose pregnancy test is negative within 14 days before treatment, and who agree to use effective contraception during treatment and for 6 months after, and who are not breastfeeding during treatment.
• Male patients who agree to either abstain from heterosexual intercourse or use contraception during the trial.

Who may not be able to join:

• People who cannot provide a pathology report showing their cancer changed type.
• People with a known history of severe allergic reactions to any monoclonal antibody treatment, or a known allergy to carboplatin or etoposide.
• People with active cancer spread to the brain or spinal fluid lining, unless their brain metastases have no symptoms or have been stable for at least 4 weeks after treatment.
• People who have received systemic cancer treatment or other immune checkpoint therapies after their cancer changed type, or who have previously had or are planning an organ or bone marrow transplant.
• People who have had an active infection requiring treatment with antibiotics or antiviral medication within 14 days before starting the trial.
• People who have had a heart attack within the past 6 months, or who have poorly controlled heart rhythm problems, significant heart failure, a weakened heart pump function (ejection fraction below 50%), or fluid build-up around the lungs, heart, or abdomen that requires medical treatment.
• People with uncontrolled high calcium levels in the blood, poorly controlled blood pressure, blood clots in deep veins, people currently taking blood thinners or platelet-affecting medications, people who have previously had serious bleeding linked to certain cancer treatments, or people with known active or suspected autoimmune diseases that require ongoing immune-suppressing treatment.
• People whose investigators believe may be unlikely to show clear signs of drug-related lung side effects, or people whom the investigator considers unsuitable for any other reason.
• People with active hepatitis B or hepatitis C, a positive syphilis test, known or newly detected HIV infection, or a known history of substance or drug abuse.
• People who have had another active cancer in the past 5 years or who currently have another cancer.
• People who received a live or weakened live vaccine within 28 days before starting the trial, who plan to receive such a vaccine during the study, or who had major surgery within that same period. (Inactivated flu vaccines are permitted.)
• People with spinal cord compression that has not been fully treated with surgery or radiotherapy, or people who received intensive radiotherapy within 3 months before starting the trial.
• People who are currently in another clinical trial, or who took part in another clinical trial and received a study treatment within the past 3 months or within 5 half-lives of that treatment, whichever is longer.

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