after joining the study, you will be randomly placed into one of three groups: daraxonrasib alone, daraxonrasib together with gemcitabine and nab‑paclitaxel, or gemcitabine plus nab‑paclitaxel alone. the assignment determines which medicines you will receive during the trial.

before any medication is given, a series of tests will be performed. these include a physical examination, blood tests, imaging scans of the pancreas, and questionnaires about your current health and quality of life. the results provide a reference point for later comparisons.

treatment is organized into cycles that last 28 days each. the first cycle begins after the baseline assessments are completed.

if you are in the daraxonrasib monotherapy arm or the combination arm, you will take one tablet containing 300 mg of daraxonrasib by mouth each day. the tablet is taken once daily throughout every 28‑day cycle, continuing until the study ends or your doctor decides to stop the medication.

if you are in the combination arm or the comparator arm, you will receive an infusion through a vein on day 1 of each 28‑day cycle. the infusion contains:

– gemcitabine at a dose of 1000 mg per square meter of body‑surface area,

– nab‑paclitaxel at a dose of 125 mg per square meter of body‑surface area.

both medicines are given together during the same visit. the infusion is administered by trained staff and takes several hours.

you will attend clinic appointments at the beginning of each cycle and may have additional visits as needed. during these visits, blood will be drawn to check organ function, vital signs such as blood pressure and temperature will be measured, and you will be asked about any side effects. questionnaires about pain and overall health may also be completed.

if you receive daraxonrasib, blood samples will be collected before taking the morning tablet (pre‑dose trough) and after the tablet (post‑dose) at specific times up to day 1 of cycle 5. these samples help researchers understand how the drug behaves in the body.

periodic scans, such as CT or MRI, will be performed approximately every 8 weeks to determine whether the cancer is responding to treatment, stable, or progressing. the results are compared with the baseline images.

the 28‑day cycles repeat as long as the cancer does not grow, you do not develop unacceptable side effects, and the study has not reached its maximum follow‑up time of about 2 years. each new cycle follows the same medication schedule described in steps 4 and 5.

when treatment stops—either because of disease progression, side effects, or the end of the study period—you will continue to be monitored for overall survival and long‑term safety. follow‑up visits may occur every few months for up to approximately 2 years after the last dose.