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 non-small cell lung cancer (a common type of lung cancer), confirmed by a laboratory tissue test.
• People whose cancer has been classified after surgery as stage IB, IIA, IIB, IIIA, or IIIB (with a specific type of lymph node involvement called N2), based on the 8th edition of an internationally recognised staging system.
• People whose surgery successfully removed all visible cancer (called a complete or R0 resection), with lymph node samples taken as required by surgical guidelines.
• People who had a lobectomy, sleeve resection, bilobectomy, or pneumonectomy (types of lung surgery); those who had smaller procedures such as segmentectomy or wedge resection may be considered only if complete removal of cancer can be confirmed.
• People whose cancer did not completely disappear (i.e., did not achieve a full pathological response) in the surgical sample after pre-surgery treatment.
• People who received pre-surgery (neoadjuvant) treatment with platinum-based chemotherapy combined with an immunotherapy drug (anti PD-1).
• People who have not received radiation therapy before or after surgery, and are not scheduled to receive it — including those with N2 disease who would otherwise require post-operative radiotherapy (those patients would not be eligible).
• People for whom at least 3 weeks have passed since their lung surgery before joining the trial, and who are able to start adjuvant (post-surgery) treatment between 3 and 10 weeks after surgery.
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity (confirm with trial site).
• People aged 18 years or older.
• People whose hospital has already measured and can provide their PDL1 value (a marker measured on cancer cells) before joining the trial.
• People who have had a PET-CT scan and a brain CT scan before joining the trial, confirming the cancer has not spread to distant parts of the body.
• People with adequate blood counts and organ function as assessed by the trial site.
• People who have read and signed an informed consent form agreeing to take part in the trial.
• Women who could become pregnant, and their partners, who agree to use highly effective contraception during the trial — oral contraception must be used alongside an additional contraceptive method due to possible interactions with the study drugs.
• Men with female partners who could become pregnant, who agree to use highly effective contraception during the trial.
• Women who have not gone through menopause and have not had surgery to prevent pregnancy must have a negative blood pregnancy test within 14 days before starting the study treatment.
• People who are able to follow the treatment plan and attend required follow-up visits.
• People with a life expectancy of more than 12 weeks.

Who may not be able to join:

• People with a history of another cancer, unless it was: non-melanoma skin cancer that was properly treated; or a cancer treated with curative intent that has shown no signs of returning for more than 3 years, and the treating doctor considers the risk of it returning to be low.
• People whose tumour (T4) has grown into the heart, major blood vessels, the airway junction (carina), trachea, oesophagus, or spine.
• People known to have specific genetic changes in their cancer (ALK translocation, STK11 or KEAP1 mutations) before entering the trial.
• People with a type of lung cancer called adenocarcinoma who have not yet been tested for common EGFR gene mutations — and anyone found to have any known EGFR mutation cannot be enrolled.
• People whose lung cancer is a mix of small cell and non-small cell types, a carcinoid tumour, or large cell neuroendocrine carcinoma.
• People with active chronic inflammatory bowel disease (such as ulcerative colitis or Crohn's disease), or who have had a gastrointestinal perforation (a hole in the gut) within the past 6 months.
• People who received a live attenuated vaccine (a type of vaccine using a weakened live virus) within 30 days before joining the trial.
• People with a history of a primary immune system disorder, a history of having received an organ transplant, use of immune-suppressing medications within 28 days before joining, or a history of severe immune-related side effects (grade 3 or 4) from previous immunotherapy.
• People with active or uncontrolled infections, or serious medical conditions that may prevent safe participation as outlined in the trial protocol.
• People with untreated or uncontrolled heart or cardiovascular problems, or who have symptoms of heart dysfunction.
• Women who are pregnant or breastfeeding.
• People for whom complete surgical removal of the cancer (R0 resection) cannot be confirmed.
• People with an active, known, or suspected autoimmune disease — though some conditions such as type 1 diabetes, thyroid hormone deficiency requiring only replacement therapy, certain skin conditions not needing systemic treatment, or conditions not expected to return without a trigger may still be considered (confirm with trial site).
• People who require ongoing systemic treatment with corticosteroids or other immune-suppressing medications within 14 days of joining the trial — though inhaled or topical steroids and low-dose replacement steroids may be permitted in the absence of active autoimmune disease (confirm with trial site).
• People with active hepatitis B or hepatitis C virus infection, or a history of either with a detectable viral load.
• People with a known allergy or hypersensitivity to any component of the study drugs.
• People with fluid around the lung (pleural effusion) or around the heart (pericardial effusion), which would be considered signs of cancer spread unless proven otherwise — though very small pleural effusions that cannot be safely sampled may still be considered (confirm with trial site).
• People with a known history of HIV-1 or HIV-2 with a detectable viral load, or who are taking medications that may interfere with how a study drug called SN-38 is processed by the body.
• People who had a severe infection within 4 weeks before joining, including hospitalisation for infection complications, bacteria in the bloodstream, or severe pneumonia.
• People with a medical, mental, neurological, or psychological condition that, in the opinion of the trial doctor, would prevent them from understanding the study information or following the study procedures.
• People with serious lung problems caused by other existing lung conditions, autoimmune or inflammatory conditions affecting the lungs, or those who have had a full lung removal (pneumonectomy).
• People receiving systemic immune-suppressing medications.
• People with uncontrolled health conditions that may affect their ability to comply with the trial requirements.
• Sexually active men and women who could become pregnant who are not willing to use effective contraception throughout the study.

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