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 locally advanced (cannot be removed by surgery) or metastatic (spread to other parts of the body) non-small cell lung cancer, confirmed by a biopsy or tissue test, with a specific genetic change called KRAS G12D mutation detected in their tumour tissue or blood.
• People whose cancer has grown or come back after receiving platinum-based chemotherapy together with, or separately from, an immunotherapy drug (called an anti-PD-1 or PD-L1 treatment), in the advanced or metastatic stage of their disease.
• People whose cancer previously came back during or within 6 months of finishing early-stage chemotherapy (given before or after surgery), where that earlier treatment counts as one line of advanced-stage therapy for eligibility purposes (confirm with trial site).
• People whose cancer previously came back during or within 6 months of finishing combined treatment (such as chemotherapy with radiation) for advanced but non-metastatic disease, where that earlier treatment counts as one line of advanced-stage therapy for eligibility purposes (confirm with trial site).
• Women who are not pregnant, not breastfeeding, and either cannot become pregnant or have had a negative pregnancy test at the start of the trial, and who agree to use contraception for at least 6 months after the last dose of the study drug setidegrasib, or at least 2 months after the last dose of docetaxel, whichever applies.
• People who agree to provide a tumour tissue sample and a blood sample before or at the start of the trial.
• People who are considered generally well enough to carry out daily activities with no or only minor limitations, based on a standard medical assessment taken within 7 days before joining the trial.

Who may not be able to join:

• People who have untreated or actively symptomatic cancer that has spread to the brain or central nervous system, including those with untreated brain metastases even if they are causing no symptoms; people with previously treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site).
• People whose lung cancer has features of both small-cell and non-small cell lung cancer types mixed together.
• People whose cancer has spread to the thin layers of tissue surrounding the brain and spinal cord (called leptomeningeal disease).
• People who have another active cancer that has required treatment within the past 2 years, apart from certain minor, apparently cured skin cancers, superficial bladder cancer, or very early-stage cervical or breast cancer.
• People with a known active hepatitis B or hepatitis C viral infection.
• People with HIV infection who have had a serious opportunistic infection in the past 12 months, are not yet stable on HIV medication for at least 4 weeks, or whose immune cell counts or viral levels do not meet specific thresholds (confirm with trial site).
• People who currently have moderate or severe nerve damage causing symptoms such as numbness or tingling in the hands or feet (grade 2 or higher peripheral neuropathy).
• People who have uncontrolled fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once a month.
• People who have received radiation therapy within 14 days before joining the trial, or who have not yet recovered from radiation side effects (except hair loss).
• People whose lung cancer has a different actionable genetic mutation for which an approved targeted treatment is available locally, such as KRAS G12C, certain EGFR mutations, ALK or ROS1 rearrangements, NTRK or NRG1 fusions, BRAF V600E, MET exon 14, RET rearrangements, or HER2 activating mutations.
• People who have previously been treated with docetaxel (a chemotherapy drug) or any treatment specifically targeting the KRAS gene, including KRAS inhibitors, degraders, RNA-based therapies, vaccines, or cell therapies.
• People who need to take certain medications that strongly affect how the body processes specific drugs through liver enzymes or transport proteins (confirm specific medications with trial site).

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