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:

• You must be able to give written consent to take part in the study.
• You must be 18 years old or older.
• You must have been diagnosed with non-small cell lung cancer (NSCLC) that has spread or cannot be treated with the aim of a cure, confirmed by a lab test on a tissue or cell sample.
• You must have a specific gene change (mutation) in a gene called EGFR — specifically the type known as Exon 19 deletion and/or L858R — confirmed by an approved laboratory.
• You must be able to provide a stored tumor sample so the study lab can confirm your EGFR mutation.
• Depending on which part of the trial you join: you may need to have already tried at least one EGFR-targeted treatment and platinum-based chemotherapy that stopped working or caused intolerable side effects; or have tried one specific type of EGFR-targeted treatment (a third-generation EGFR TKI) that stopped working; or have never received treatment before (confirm which group applies to you with the trial site).
• You must be in relatively good general health, able to carry out daily activities with little or no difficulty (ECOG score of 0 or 1), and expected to live at least 12 weeks.
• If you have cancer that has spread to the brain, it must be stable (not actively getting worse).
• You must have at least one area of cancer that can be measured on a scan, following standard measurement rules.
• Your blood counts and organ functions (such as liver and kidneys) must be at an acceptable level.
• Male patients whose female partners could become pregnant must use barrier contraception (such as condoms) and must not donate sperm during the study and for 3 months after the last dose.

Who may not be able to join:

• You have certain other types of less common EGFR gene changes (such as G719X, S768I, L861Q, or exon 20 insertions) — this applies to Part B of the trial (confirm with trial site).
• Your lung cancer has features of another type of lung cancer called small cell lung cancer (SCLC), or has changed into that type.
• You have received certain treatments too recently, including: immunotherapy or antibody-based treatments within the past 4 weeks; chemotherapy or other anti-cancer drugs within the past 14 days; certain radiotherapy within the past 7 to 28 days depending on the type; or certain medications that interfere with how the study drug is processed by the body, unless you have stopped them long enough in advance (confirm specific timeframes with the trial site).
• You still have significant side effects from previous cancer treatments that have not resolved.
• You have cancer that is pressing on your spinal cord, or cancer that has spread to the lining around your brain and spinal cord.
• You have had another type of cancer within the past 2 years.
• You have serious uncontrolled health conditions, such as very high blood pressure or uncontrolled bleeding problems.
• You have an active infection, including hepatitis B, hepatitis C, HIV, or active COVID-19.
• You have certain heart rhythm or electrical problems, including a specific measurement on a heart tracing (ECG) that is too high, or other factors that raise your risk of heart rhythm issues.
• You have a history of, or currently have, a lung condition called interstitial lung disease (ILD).
• You have a condition that would stop you from properly absorbing the study drug through your digestive system (confirm with trial site).
• You are pregnant or breastfeeding.
• You are allergic to any ingredients in the study drug (DZD6008).
• You were involved in planning or running this study.
• The study doctor does not think you would be able to follow the study procedures.

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