Badanie porównujące skuteczność ZL‑1310 i chlorowodorekiem topotekanu u pacjentów z nawracającym drobnokomórkowym komórkowym rakiem płuca

Enrollment and consent

After joining the study you sign the informed consent form and confirm eligibility Criteria.

Baseline assessments

Initial medical examinations, laboratory tests, and imaging studies are performed to document the status of small cell lung cancer before treatment begins.

Randomization

The study assigns you to either the test arm receiving zl-1310 or the comparator arm receiving topotecan hydrochloride according to the investigator’s choice.

Treatment administration – test arm

You receive zl-1310 by intravenous infusion at a dose of 1.60 mg/kg. the infusion is given as a single administration per treatment cycle as defined in the protocol.

Treatment administration – comparator arm

If assigned to the comparator arm you receive topotecan hydrochloride either orally at a dose of 2.30 mg/m2 or intravenously at a dose of 1.50 mg/m2. the selected route is administered according to the schedule defined in the protocol.

Regular monitoring visits

During treatment you attend scheduled visits for physical Examination, blood tests, and Assessment of side effects.

Imaging studies are repeated at predefined intervals to evaluate tumor response.

Assessment of tumor response

Response is measured using standardized Criteria (RECIST v1.1) by an independent review and by the investigator.

Recording adverse events

Any new symptoms or laboratory changes are documented and graded according to the National cancer Institute common Terminology Criteria for adverse events version 5.0.

Treatment continuation or discontinuation

Treatment continues until disease progression, unacceptable toxicity, or completion of the planned number of cycles as defined in the protocol.

Final study assessments

After the last dose a final set of examinations, imaging, and questionnaires is performed to determine overall survival and quality‑of‑life outcomes.