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 aged 18 years or older who weigh at least 50 kg (about 110 pounds)
• People who have been diagnosed with extensive-stage small cell lung cancer (a type of lung cancer that has spread widely), confirmed by a tissue sample examined in a laboratory
• People whose cancer has come back or gotten worse after receiving at least one treatment that included platinum-based chemotherapy, or whose cancer only stabilised (did not shrink) after completing one round of platinum-based chemotherapy
• People previously diagnosed with an earlier, less-spread form of small cell lung cancer who received chemotherapy and radiation together and have now developed widespread recurrent disease
• People who have previously received certain immune-based cancer treatments (checkpoint inhibitors such as anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies)
• People whose general health and ability to function falls within an acceptable range, as rated by their doctor on a standard scale (ECOG score of 0, 1, or 2 — meaning fully active to capable of limited self-care)
• People who have at least one tumour that can be treated with a focused, high-dose form of radiation called SBRT
• People who have at least one additional separate tumour site that a doctor can safely take a tissue sample (biopsy) from — participants must be willing to have biopsies taken before treatment starts and about two weeks after the radiation treatment is completed
• People with brain tumours from the cancer (metastases) that are not causing symptoms, or that have already been treated, provided they are not taking corticosteroid medications at a dose of prednisone 10 mg per day or more, and provided radiation to the brain was completed at least 7 days (focused radiation) or 2 weeks (whole-brain radiation) before starting the trial
• People who have at least one measurable area of cancer that can be tracked using standard imaging measurements
• People who agree to provide blood samples for research purposes at set timepoints during the study
• People who have finished any previous palliative (symptom-relief) radiotherapy at least one week before starting the trial treatment
• People taking anti-seizure medications (anticonvulsants) are permitted to participate
• People who are willing and able to follow the study's requirements around contraception and reproductive precautions during treatment and for at least five months after the last dose of study drugs

Who may not be able to join:

• People whose cancer has spread to the lining surrounding the brain or spinal cord (leptomeningeal disease)
• People with brain metastases that are causing symptoms and have not yet been treated
• People with spinal cord compression that has not been properly treated with surgery and/or radiation, or whose spinal cord compression has been treated but has not been stable for at least one week before enrolment
• People with cancer-related pain that is not well controlled
• People with cancer-related symptoms (such as bone pain or nerve pressure) that have not yet been treated with palliative radiotherapy when it would be appropriate to do so
• People who have untreated tumours likely to cause serious problems with further growth (such as tumours pressing near the spinal cord), where local treatment should be considered first
• People who have fluid build-up around the lungs, heart, or abdomen that cannot be controlled and requires drainage once a month or more often (people with a long-term drainage tube already in place may still be eligible — confirm with trial site)
• People with high blood calcium levels that are not controlled or are causing symptoms
• People with an active autoimmune disease or a history of certain autoimmune conditions (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease), with some exceptions including:
  • People with an underactive thyroid caused by autoimmune disease who are on thyroid hormone replacement
  • People with well-controlled type 1 diabetes on insulin
  • People with certain skin conditions such as eczema, psoriasis, or vitiligo that affect the skin only, are mild, and have not required strong treatments in the past 12 months
• People with a history of certain lung conditions such as idiopathic pulmonary fibrosis, organising pneumonia, or drug-induced lung inflammation, or who have signs of active lung inflammation on a current scan (a history of radiation-related lung scarring in a previously treated area is generally permitted — confirm with trial site)
• People with active tuberculosis
• People who have had a significant heart or blood vessel problem within the past three months, such as a heart attack or stroke, or who have an unstable heart rhythm or unstable chest pain; people with moderate-to-severe heart failure may also be excluded unless a recent heart scan shows the heart is pumping adequately
• People who have had a major surgical procedure (other than for diagnosis) within the four weeks before starting the trial, or who expect to need major surgery during the study
• People who have had another type of cancer within the past year, with some exceptions for certain low-risk cancers that are considered highly unlikely to spread or cause death (confirm with trial site)
• People who have had a serious infection requiring hospitalisation within the past four weeks, or who have an active, uncontrolled infection at the time of enrolment
• People who have taken antibiotic treatment (by mouth or through a drip) within the past two weeks, unless the antibiotics are being used to prevent (not treat) an infection
• People who have previously received a bone marrow or organ transplant from another person
• People who have received a live vaccine within four weeks before starting the trial, or who expect to need one during or shortly after treatment
• People currently receiving antiviral treatment for hepatitis B virus
• People who have received another experimental (investigational) treatment within 28 days before starting the trial
• People who have received any approved systemic cancer treatment within three weeks before starting the trial
• People who have received immune-stimulating medications (such as interferon or interleukin-2) within four weeks or five half-lives of those medications before starting the trial
• People who have received immune-suppressing medications (such as corticosteroids, methotrexate, or similar drugs) within two weeks before starting the trial, with some exceptions for low-dose or short-term use (confirm with trial site)
• People with a history of severe allergic reactions to certain types of laboratory-made antibody treatments
• People with a known allergy to any component of the study drugs atezolizumab or iadademstat
• People with a condition that prevents them from properly absorbing medications taken by mouth
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial or within five months after the last dose of study treatment
• People with a known active infection with HIV, hepatitis B, or hepatitis C (people with past exposure but no active infection may be considered — confirm with trial site)
• People whose recent blood test results show that certain organs such as the liver, kidneys, or blood-forming system are not functioning well enough (specific laboratory thresholds apply — confirm with trial site)
• People with abnormal blood clotting test results, unless they are already on blood-thinning (anticoagulant) medication
• People with uncontrolled high blood pressure (systolic above 180 mmHg or diastolic above 95 mmHg) — blood pressure medication to bring this under control before starting treatment is allowed
• People currently taking certain antidepressant medications called tranylcypromine or phenelzine
• People who have not yet recovered from moderate or severe side effects (grade 2 or higher) from previous cancer treatments, with the exception of hair loss and skin pigment changes
• People with moderate or severe nerve damage (grade 2 or higher neuropathy) — these cases are reviewed individually (confirm with trial site)
• People with a history of serious bleeding, including any previous bleeding in the brain or a bleeding stroke, or who have had gastrointestinal bleeding in the past three months
• People with an uncontrolled blood clotting disorder called disseminated intravascular coagulation
• People who are unwilling or unable to receive blood products if needed
• People with a history of certain immune system deficiencies or autoimmune diseases (a detailed list applies — confirm with trial site)

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