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:

To join the radiation (first) phase, people generally need to meet these criteria:

• A confirmed diagnosis of non-small cell lung cancer (NSCLC), based on tissue or cell testing
• Cancer that is at a stage where surgery or combined chemotherapy-and-radiotherapy treatment is not suitable
• Stage IIB or Stage III lung cancer (using the TNM 8th edition staging system)
• A planned course of radiotherapy aimed at curing the cancer, at a dose of 60Gy, with or without prior chemotherapy
• The local lung cancer specialist team and a cancer radiation doctor have agreed that radical radiotherapy is appropriate
• If chemotherapy was given before, it must have finished no more than 10 weeks before radiotherapy is due to start
• Aged 18 or older
• Life expectancy estimated to be more than 6 months
• A functional ability score (Karnofsky scale) of 70 or above, meaning the person is reasonably able to carry out normal daily activities
• Breathlessness rated below level 3 on the MRC breathlessness scale (confirm with trial site)
• Lung function test results meeting minimum thresholds: FEV1 at or above 35% of the expected value, and DLCO/TLCO at or above 35% of the expected value
• Fully informed about the trial and having signed a consent form
• Willing and able to follow the trial requirements, with the mental capacity to do so; people who can become pregnant must use effective contraception during treatment and for 4 months after the last treatment dose, and men must use effective contraception for 6 months after the last treatment dose
• Blood and organ function results meeting the levels set out in the trial's main protocol
• Body weight above 30kg

To join the consolidation (second) phase, people generally also need to meet these criteria:

• At least 4 weeks and no more than 8 weeks have passed since finishing radiotherapy
• Any side effects from radiotherapy have settled to a mild level (grade 1 or lower); if there is any lung inflammation (pneumonitis) after radiotherapy, it must be causing no symptoms (grade 1), and must not require steroid treatment
• Karnofsky performance score of 70 or above
• Blood test results meeting the levels set out in the trial's main protocol
• No known allergy to the ingredients of the drug durvalumab
• Body weight above 30kg

Who may not be able to join:

During the radiation phase, people may not be eligible if they have:

• A tumour that is a mix of non-small cell and small cell lung cancer
• Cancer that has continued to grow during earlier chemotherapy
• Taken part in another clinical trial or used an experimental device in the 4 weeks before treatment is due to start
• Another current or previous cancer that may affect life expectancy (other than NSCLC)
• A history of a lung condition called interstitial pneumonitis (scarring or inflammation of the lung tissue)
• Previously had radiotherapy to the chest
• Been treated with certain drugs known to harm the lungs (such as busulfan or bleomycin) within the past year, or at any point in the past if lung damage occurred as a result; people who received nitrosourea drugs (such as carmustine or lomustine) in the past year without developing lung problems may still be eligible
• An abnormal heart rhythm reading (QTcF above 470 milliseconds) on three separate heart trace (ECG) tests
• Previously had an organ or tissue transplant (either from their own body or from a donor)
• Difficulty swallowing tablets, or a long-term gut condition that would likely stop the trial medication from being properly absorbed
• Moderate or severe nerve damage causing numbness or tingling in the hands or feet (grade 2 or higher peripheral sensory neuropathy)
• A confirmed positive test for HIV, or an active hepatitis B or C infection
• A positive pregnancy test at the time of eligibility assessment, or who are currently breastfeeding
• Ongoing significant side effects (above grade 2) from previous cancer treatment, apart from hair loss
• A blood or bone marrow disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML), or test results suggesting these conditions
• Had major surgery within 2 weeks before being confirmed as eligible
• A serious, uncontrolled medical condition, uncontrolled infection, or a mental health condition that prevents giving informed consent — examples include uncontrolled heart rhythm problems, uncontrolled high blood pressure, active bleeding, a heart attack in the past 3 months, a recent major seizure, or active COVID-19
• An active or previously diagnosed autoimmune or inflammatory condition, such as inflammatory bowel disease (including ulcerative colitis or Crohn's disease), lupus, sarcoidosis, Wegener's disease, Graves' disease, rheumatoid arthritis, or similar conditions

During the consolidation phase, people may not be eligible if they have:

• Cancer that grew or spread during or after radiotherapy
• Decided they do not wish to continue with the consolidation treatment
• Previously been treated with anti-PD-1 or anti-PD-L1 drugs (a type of immunotherapy)
• Had major surgery within 4 weeks before being confirmed as eligible for the consolidation phase
• Used immunosuppressive medication (drugs that reduce the immune system's activity) within the 14 days before the first dose of durvalumab
• A serious uncontrolled medical condition, active gut infection, or other active uncontrolled infection
• An active or previously diagnosed autoimmune or inflammatory condition, such as those listed above under the radiation phase

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