Study on DRP-104 for Patients with Specific Genetic Changes in Non-Small Cell Lung Cancer

Inclusion Criteria

• Must be 18 years or older.
• Have advanced or recurrent non-small cell lung cancer with specific genetic changes (NFE2L2 or KEAP1 alterations).
• Cancer must be measurable by standard criteria.
• Cancer must have progressed after standard chemotherapy and immunotherapy.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Agree to provide a tumor sample for research, either from existing tissue or a new biopsy if safe.
• Have adequate organ function, including:
  • Neutrophil count of at least 1500/uL without recent growth factor support.
  • Hemoglobin level of at least 9 g/dL, stable without recent transfusions.
  • Platelet count above 75,000/uL without recent transfusions.
  • Liver and kidney function within specified limits.
  • Heart's electrical activity within normal range.
• Women and men must agree to use effective contraception during the study and for a specified period after the last dose of DRP-104.
• Women must not be pregnant or breastfeeding during the study and for a specified period after.

Exclusion Criteria

• Have untreated or unstable brain metastases.
• Have leptomeningeal disease or untreated spinal cord compression.
• Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
• Have not recovered from side effects of previous cancer treatments to a mild level, except for certain conditions like hair loss.
• Have used a similar type of drug (glutaminase inhibitor) before.
• Have had recent major surgery or certain cancer treatments within a specified time before starting the study.
• Have a history of other cancers, except for certain non-threatening types.
• Have a known history of HIV or active hepatitis B or C infections.
• Have significant digestive issues that could affect the study.
• Have uncontrolled illnesses or psychiatric conditions that could interfere with the study.
• Have significant heart problems or abnormal heart rhythms.
• Have any other medical condition that could make the study unsafe or difficult to follow.