Phase 1 Lung Cancer Trial, Recruiting

Written by an AI model from the 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 aged 18 or older at the time of joining the study
• People with a general health and activity level rated as fully active or with only minor limitations (ECOG score of 0 or 1)
• People who have been diagnosed with non-small cell lung cancer (NSCLC) at stage II through IIIC(N3), confirmed by laboratory analysis of tumour tissue, where the cancer is considered "borderline resectable" — meaning surgery may be possible but is uncertain — before any radiation or systemic treatment has started
• People whose cancer, if it has spread to lymph nodes on the opposite side of the chest (contralateral N3 disease), does not involve the scalene or supraclavicular lymph nodes in the neck area
• People whose case has been reviewed by a team of specialists at a multidisciplinary thoracic tumour board before joining
• People who have a tumour tissue sample available for specialised genetic testing, including testing to determine EGFR and ALK gene status — this may come from a previously stored tissue sample or a new biopsy if needed
• People without major health conditions that would make surgery too risky
• People whose lung function is assessed by the surgeon as adequate to tolerate the planned lung surgery
• People whose blood counts and organ function meet the required levels, including platelets, haemoglobin, white blood cells, kidney function, liver function, and bilirubin levels (confirm specific values with the trial site)
• People who are able to understand the study and have signed a written consent form approved by an ethics review board, before any study-related procedures begin
• Women who could become pregnant must have a negative pregnancy test within 30 days of starting the study

Who may not be able to join:

• People whose cancer has spread to other parts of the body (Stage IV disease), including cancer-related fluid around the lungs
• People whose cancer has spread to the scalene or supraclavicular lymph nodes (located in the neck/collarbone area) — in cases where this is suspected, a biopsy may be done to confirm eligibility
• People whose tumour has specific gene changes known as EGFR mutations (L858R or Exon 19 deletion) or ALK translocation
• People who have cancer that has spread to the brain
• People with an active autoimmune disease that would prevent the use of immunotherapy — though some conditions such as type 1 diabetes, thyroid conditions requiring only hormone replacement, or certain skin conditions not needing systemic treatment may still be eligible (confirm with trial site)
• People who are currently taking steroid medications (above a certain dose) or other immune-suppressing medications within 14 days of joining — with some exceptions for inhaled or topical steroids
• People with serious or poorly controlled medical conditions
• People whose lung cancer is of a specific type called large-cell neuroendocrine carcinoma
• People who have previously received chemotherapy or any other cancer treatment for early-stage NSCLC
• People who have previously received certain immunotherapy treatments that target pathways involving PD-1, PD-L1, CTLA-4, or similar immune checkpoint proteins
• People with active hepatitis B or hepatitis C infection — those with past resolved hepatitis B or negative hepatitis C RNA tests may still be eligible (confirm with trial site)
• People with poorly controlled or untreated HIV or AIDS — people with well-controlled HIV meeting all specified criteria may be eligible (confirm with trial site)
• People who have had another active cancer in the past 3 years, with some exceptions for certain easily treated skin cancers, superficial bladder cancer, or non-invasive cancers of the prostate, cervix, or breast
• People with a known allergy or sensitivity to nivolumab or any of the chemotherapy agents used in the study
• People who have received an organ transplant from another person
• Women who are pregnant or breastfeeding
• People of reproductive capacity who are not willing to use effective contraception from the time of screening until 90 days after surgery is completed

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