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:

• People who have been diagnosed with stage IB to IIIA non-small cell lung cancer (a specific type and stage of lung cancer), confirmed by a laboratory, regardless of a certain protein marker level on the tumour.
• People whose lung cancer is considered removable by surgery according to standard medical guidelines, and who are willing to have that surgery after an initial course of treatment.
• People whose tumour can be safely reached for a biopsy using a tube through the airways, a small camera through the chest wall, or a needle through the skin — and who are willing to have that biopsy before treatment begins.
• People who have not had any previous treatment for their lung cancer.
• People whose cancer can be measured on scans according to a standard set of rules (called RECIST 1.1).
• People aged 18 years or older.
• People weighing more than 30 kilograms.
• People who are generally well enough to carry out daily activities with little to no limitation (as measured by a standard medical scale called ECOG, scoring 0 or 1).
• People whose lungs have enough reserve function, as shown by specific breathing tests done before any surgery.
• People whose blood oxygen and carbon dioxide levels meet required thresholds, if their oxygen levels measured by a finger monitor are at or below a certain level at the screening visit (confirm with trial site).
• People whose blood counts, liver, kidney, and other organ functions meet specific minimum levels as measured by blood tests (confirm with trial site for exact values).
• People who are able to become pregnant must be willing to use a highly effective form of contraception (such as hormonal methods, an intrauterine device, surgical sterilisation, or abstinence) throughout treatment and for up to 6 months after the last dose — or up to 14 months if cisplatin is part of the chemotherapy.
• People who are able to father a child must be willing to use an effective form of contraception (such as a barrier method, surgical sterilisation, or abstinence) throughout treatment and for up to 3 months after the last dose — or up to 11 months if cisplatin is part of the chemotherapy.
• People who are breastfeeding must be willing to stop breastfeeding from the start of treatment through to 3 months after the last dose.
• People living with HIV or a history of AIDS-related illness may be eligible if they are on appropriate antiviral treatment and their HIV viral load is below 400 copies/mL.
• People who are willing to not donate blood from the time they join the study until 3 months after the last dose.
• People who are willing to be enrolled in a related research study that looks at genetic and other biological changes in thoracic (chest) cancers (protocol 06C0014).
• People who understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose other health conditions make surgery medically too risky.
• People whose tumour has grown into nearby structures such as the diaphragm, heart, major blood vessels, windpipe, oesophagus, or spine (T4 tumours).
• People who previously had to stop an immune checkpoint inhibitor treatment for a different cancer due to a serious immune-related side effect.
• People whose tumour has known changes in the EGFR or ALK genes.
• People with a history of active autoimmune disease such as colitis (bowel inflammation), nephritis (kidney inflammation), hypophysitis (pituitary gland inflammation), or neuropathy (nerve damage) — with some exceptions such as type 1 diabetes, vitiligo, alopecia, psoriasis, or thyroid conditions not needing immune-suppressing treatment.
• People with a history of lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease).
• People with significant heart or blood vessel problems, including a stroke or heart attack in the past 6 months, unstable chest pain, moderate-to-severe heart failure, serious heart rhythm problems, significant bleeding, or a significant blood clot in the lungs at the screening visit.
• People with active Hepatitis A, Hepatitis B, or Hepatitis C infection at the time of screening.
• People with other active infections that require systemic (whole-body) treatment at the time of screening.
• People who test positive on a pregnancy test at screening (for those who could become pregnant).
• People taking corticosteroid medications (such as prednisone) at higher than a low background dose, or inhaled corticosteroids, within 14 days before starting treatment — though low-dose topical, eye-drop, or joint-injection forms may be allowed.
• People who have had a major surgical procedure within 28 days before starting treatment.
• People who have had an organ transplant from another person.
• People with a history of another cancer, unless that cancer was treated with the intent to cure and there has been no known active disease for at least 5 years before starting treatment.
• People who have received a live vaccine within 30 days before starting treatment (inactivated vaccines such as the flu shot are generally permitted).
• People who have taken an experimental drug in another clinical trial within 14 days before starting treatment.
• People with a known allergy to mannitol (a substance that may be used in the study).
• People who have used herbal or natural remedies that may affect the immune system within 7 days before starting treatment.
• People with ongoing or uncontrolled illness, or any situation that would make it difficult to follow the study requirements.

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