Phase 3 Lung Cancer Trial, Active, Not 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 are in generally good physical condition and able to carry out normal daily activities, with little or no limitation (rated 0 or 1 on a standard oncology performance scale)
• People who have been diagnosed with a specific type and stage of non-small cell lung cancer (NSCLC), confirmed by tissue or cell testing, ranging from Stage IB (tumours 4 cm or larger) to Stage IIIA, according to a specific international staging system
• People who have had complete surgical removal of their NSCLC between 4 and 12 weeks before joining the trial, and who have sufficiently recovered from that surgery
• People whose surgery included either a procedure to examine lymph nodes in the chest before the operation, or a required level of lymph node sampling or removal during surgery (confirm with trial site for full details on what qualifies)
• People whose doctors consider them suitable to receive a cisplatin-based chemotherapy treatment
• People with adequate blood counts and organ function as determined by testing
• Women who could become pregnant must have a negative blood pregnancy test within 14 days before starting the cisplatin-based chemotherapy phase, and again within 14 days before starting the next phase of the trial

Who may not be able to join:

• People with an illness or condition that may make it difficult to understand or follow the study procedures
• People who are pregnant or breastfeeding
• People who have previously received systemic chemotherapy, unless the last dose was more than 5 years ago and was given with the aim of curing an early-stage cancer (exceptions may be considered by the trial's medical monitor)
• People who have received hormonal cancer therapy or radiation therapy as a cancer treatment within the last 5 years
• People who have taken part in another clinical trial involving an experimental treatment within the past 28 days
• People who have a hearing impairment
• People with a known allergy or sensitivity to any component of the chemotherapy they would be assigned, or to mannitol
• People who have previously been treated with certain types of immune-activating or immune checkpoint therapies (including anti-PD-1 or anti-PD-L1 antibody treatments)
• People who have had another cancer within the past 5 years, except for certain low-risk cancers that were treated with the expectation of a cure (such as some skin cancers, early cervical changes, or certain localised prostate or breast cancers — confirm with trial site)
• People with a history of severe allergic reactions, including anaphylaxis, to certain types of laboratory-produced antibody treatments
• People with a known allergy to the specific drug atezolizumab or to biological medicines produced using a particular laboratory cell process (Chinese hamster ovary cells)
• People with a history of autoimmune diseases — conditions where the immune system attacks the body — such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or a range of similar conditions
• People who test positive for HIV
• People with active hepatitis B or hepatitis C infection
• People with active tuberculosis
• People with significant heart or cardiovascular disease, including a heart attack or stroke in the past 3 months, certain irregular heart rhythms, unstable chest pain, or a heart condition classified as moderate or severe by standard medical criteria
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, a type of lung inflammation called organising pneumonia, drug-related lung inflammation, or unexplained lung inflammation — or who show signs of active lung inflammation on a chest scan at screening
• People who have previously had a bone marrow transplant from a donor, or a transplant of a solid organ
• People with any other disease, physical finding, or test result that raises concern about their safety in the trial or could affect the reliability of the trial results
• People whose lung cancer tissue has already been tested for a specific protein marker (PD-L1) as part of screening for a different study involving immune checkpoint treatments
• People with a specific type of lung cancer called squamous cell carcinoma are not eligible for the pemetrexed chemotherapy option within this trial
• People showing signs of active infection in the 14 days before the randomisation stage of the trial, or who had a serious infection in the 28 days before randomisation
• People who have taken antibiotic treatment by mouth or by drip in the 14 days before randomisation
• People who have had a major surgical procedure within 28 days before randomisation, or who are expected to need one during the trial
• People who have received a live vaccine within 4 weeks before starting the trial treatment, or who are expected to need one during the trial
• People who have taken certain immune-stimulating medicines (such as interferons or interleukin-2) within 4 weeks before randomisation (or within 5 half-lives of the drug, whichever is longer)
• People who have taken systemic corticosteroids or other medicines that suppress the immune system (such as prednisone, methotrexate, or similar drugs) within 14 days before randomisation

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