Phase 1 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 are able to give written, documented consent to participate.
• People aged 18 or older.
• People who have been diagnosed with non-small cell lung cancer (NSCLC) that has spread locally or to other parts of the body, and where curative treatment is not an option.
• People who have a confirmed EGFR gene mutation, tested by an approved laboratory. For certain parts of the trial, the mutation must be a specific type (called Exon19del and/or L858R).
• People who can provide a tumour tissue sample taken after their cancer stopped responding to their last EGFR-targeted treatment (for those previously treated), or before starting the study (for those not yet treated).
• People who, depending on which part of the trial they are entering, have either: stopped responding to or could not tolerate at least one prior EGFR-targeted therapy; stopped responding to one prior third-generation EGFR-targeted therapy; or have not yet received any treatment for this cancer.
• People who are in good general health (able to carry out light activity) with a life expectancy of at least 12 weeks.
• People who have cancer that has spread to the brain, provided that the brain metastases are stable.
• People whose cancer can be measured by standard imaging criteria (RECIST 1.1).
• People whose blood counts and organ functions (such as liver and kidneys) are at adequate levels.
• Male participants with female partners who could become pregnant must use barrier contraception and must not donate sperm during the trial and for 3 months after the last dose.

Who may not be able to join:

• People whose EGFR mutation is a type other than T790M or C797X (such as G719X, S768I, L861Q, or exon 20 insertions), for certain parts of the trial (confirm with trial site).
• People whose lung cancer has features of both NSCLC and small cell lung cancer, or whose cancer has transformed into small cell lung cancer.
• People who have recently received certain treatments, including: immunotherapy or antibody-based therapy within the past 4 weeks; chemotherapy, investigational drugs, or other anti-cancer drugs within the past 14 days; radiation therapy within certain timeframes depending on the extent of treatment; certain medications that strongly affect how the body processes drugs (CYP3A4 inhibitors or inducers), unless a required washout period has passed; certain other medications with a narrow safe dosing range; proton pump inhibitor medications (used for acid reflux) within the past 7 days; or major surgery within the past 4 weeks or planned during the study.
• People who still have significant side effects (above a mild level) from previous cancer treatment that have not resolved.
• People who have cancer pressing on the spinal cord, or cancer that has spread to the membranes surrounding the brain and spinal cord.
• People who have had another type of cancer within the past 2 years.
• People with severe or uncontrolled conditions such as very high blood pressure or active uncontrolled bleeding.
• People with an active infection, including hepatitis B, hepatitis C, HIV, or active COVID-19.
• People with certain heart rhythm or electrical abnormalities, including a specific measurement on a heart tracing (QTcF) above 470 milliseconds.
• People who have a history of, or currently have, a lung condition called interstitial lung disease (ILD).
• People with conditions that would prevent the study drug from being properly absorbed by the body.
• People who have received a live vaccine within 2 weeks before starting the study.
• People who are pregnant or breastfeeding.
• People who have a known allergy to the study drugs (DZD6008 or sunvozertinib) or any of their ingredients.
• People who are involved in planning or running this trial.
• People who, in the judgement of the trial doctor, are unlikely to be able to follow the study requirements.

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