Phase 3 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 II to IIIB non-small cell lung cancer (a type of lung cancer), confirmed by a laboratory test of tissue or cells, but not including cases where cancer has spread to lymph nodes on the opposite side of the chest from the tumour.
• People who have had a complete surgical removal of their lung cancer — meaning no cancer was left behind — within the past 12 weeks before joining the trial, using one of these surgery types: removal of one lobe of the lung, removal of two lobes, a sleeve resection, or removal of an entire lung. Wedge resection (removal of a small wedge-shaped piece of lung) does not meet this requirement.
• People whose surgical specimen showed a complete response — meaning no living cancer cells were found in the removed tissue or nearby lymph nodes when examined by a pathologist.
• People who have had their tumour tested for a protein called PD-L1, with a result available (even if the result is unknown or unclear).
• People who do not have certain specific gene changes in their cancer (specifically, no EGFR mutations and no ALK gene fusion).
• People who received at least two cycles of pre-surgery chemotherapy (platinum-based) combined with an immunotherapy drug (anti-PD-1 or anti-PD-L1), where that treatment is FDA-approved and listed as a standard option in recognised cancer care guidelines.
• People who are 18 years of age or older at the time of joining the study.
• People who weigh more than 30 kg (approximately 66 pounds).
• People who are well enough to carry out some daily activities, as rated on a standard scale from 0 to 2 (where 0 means fully active and 2 means able to care for oneself but unable to do work activities).
• People who have had a full medical check-up and physical examination within the 28 days before joining the trial.
• People whose blood test results within 28 days before joining meet all of the following: haemoglobin above 9.0 g/dL, neutrophil count at or above 1.5 x 10³/µL, and platelet count at or above 100 x 10³/µL.
• People whose liver function blood tests are within acceptable ranges within 28 days before joining (specific limits apply; confirm with trial site), with a special allowance for people with a condition called Gilbert's disease.
• People whose kidney function, measured by a calculation called creatinine clearance, is at or above 40 mL/min within 28 days before joining.
• People who have fully recovered from their surgery, in the opinion of their treating doctor.
• People with a known history of HIV who are on effective HIV treatment and have had an undetectable viral load within the past 6 months.
• People with a known history of chronic hepatitis B who have an undetectable viral load while on suppressive treatment, based on results from the past 6 months.
• People with a known history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load within the past 6 months.
• People who have not had an organ transplant.
• People who do not have another cancer (past or current) that their doctor believes could interfere with the safety or results of this trial.
• People who are not pregnant, not breastfeeding, and — if they could potentially have or father a child — have agreed to use effective contraception during treatment and for 6 months after treatment ends.
• People who have not received a live or live-attenuated vaccine (such as measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid, or nasal flu spray) in the 28 days before joining. Standard flu shots and COVID-19 vaccines are allowed.
• People who are willing to have biological samples (such as blood or tissue) stored for research purposes.
• People who are able to complete quality-of-life and symptom questionnaires in English or Spanish, and are willing to do so as part of the study.
• People who have been fully informed about the research nature of this trial and have signed a consent form agreeing to participate. If a person is unable to make their own decisions, a legally authorised representative may provide consent on their behalf in line with applicable regulations.

Who may not be able to join:

• People who are planning to receive any other chemotherapy, immunotherapy, biological therapy, or hormonal therapy for their lung cancer at the same time as the trial treatment.
• People who have received any systemic treatment (chemotherapy, immunotherapy, or an investigational drug) within the 28 days before joining.
• People who have had a serious reaction or medical reason preventing them from receiving immunotherapy drugs (anti-PD-1 or anti-PD-L1).
• People who have received radiation therapy to the chest after their surgery.
• People who still have unresolved side effects rated as moderate or severe (grade 2 or higher on a standard scale) from previous cancer treatment, with the exception of hair loss and skin colour changes. People with nerve-related side effects or certain long-lasting irreversible side effects may still be considered at the treating doctor's discretion (confirm with trial site).
• People who have a history of lung inflammation (pneumonitis) not caused by infection that required steroid treatment, or who have an active autoimmune condition that has required systemic treatment with immune-suppressing or disease-modifying medications in the past two years. Note: hormone replacement therapies (such as thyroid hormone, insulin, or corticosteroids for adrenal or pituitary conditions) are not counted as systemic treatment for this purpose, and steroid injections into joints are also allowed.
• People who have received a live or live-attenuated vaccine within 28 days before joining (see above for examples).
• People who have had a prior organ transplant.

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