Badanie bezpieczeństwa i skuteczności Rinatabart Sesutecan i pegfilgrastim u pacjentów z zaawansowanym niedrobnokomórkowym rakiem płuca

Initial visit and consent

You attend the first study visit after being accepted into the trial.

The study staff explains the purpose of the trial and obtains your written agreement to participate.

Baseline examinations

A complete medical history is recorded, including previous treatments for lung cancer.

Physical Examination, blood tests, and imaging studies (such as CT scans) are performed to document the current status of the disease.

These results form the reference point for later comparisons.

First administration of rinatabart sesutecan

The investigational drug rinatabart sesutecan is given by intravenous infusion (medicine delivered through a vein).

The dose specified in the protocol is 0.00 mg per square meter of body‑surface area (mg/m²).

The infusion is performed in a clinical setting under medical supervision.

Repeated infusion cycles

Subsequent doses of rinatabart sesutecan are administered at regular intervals defined by the study protocol.

Each dose uses the same amount (0.00 mg/m²) and is given as an intravenous infusion.

The schedule continues until disease progression, unacceptable side effects, or completion of the planned treatment period.

Supportive medication (pegfilgrastim)

If required, a supportive drug named pegfilgrastim may be given by subcutaneous injection (injection under the skin).

The dose listed in the protocol is 0.00 mg.

This medication is intended to help maintain normal white‑blood‑cell counts during treatment.

Regular safety and laboratory monitoring

Blood tests and physical examinations are performed before each infusion to check organ function and detect possible side effects.

Any adverse events (unwanted medical occurrences) are recorded throughout the trial, with a monitoring period of approximately four years.

Tumor response assessments

Imaging studies are repeated at predefined intervals to evaluate changes in tumor size.

The primary measurement, objective response rate (ORR), is assessed according to the RECIST v1.1 criteria (standard rules for measuring solid tumors) over an estimated period of three years.

Secondary measurements such as duration of response, disease‑control rate, progression‑free survival, and overall survival are followed for up to four years.

Pharmacokinetic sampling

Blood samples are taken at specific times to determine the highest concentration of the drug in the bloodstream (Cmax) and the time to reach that concentration (Tmax).

These measurements are collected for approximately twelve months.

Immunogenicity testing

Samples are analyzed to detect the presence of antidrug antibodies (ADAs), which may affect how the body responds to the medication.

Testing is performed during the first twelve months of the study.

Treatment discontinuation and end‑of‑treatment visit

Treatment stops when the disease shows progression, side effects become unacceptable, or the planned number of cycles is completed.

A final Assessment is performed to record the status of the disease and any lasting side effects.

Long‑term follow‑up

After treatment ends, periodic visits continue to monitor overall survival and any late side effects.

This follow‑up extends for up to four years from the start of the study.