The study focuses on Small Cell Lung Cancer, a fast‑growing type of lung cancer that often comes back after initial treatment. The main goal is to see whether a new medicine can control the tumor better and help patients live longer.
Participants will receive either the experimental drug ZL-1310, which is designed to attach to a protein called DLL3 and deliver a cell‑killing agent (known as an ADC), or a standard chemotherapy called topotecan hydrochloride. The new drug is given by intravenous infusion, while the standard therapy can be taken by mouth (oral) or also given intravenously, depending on the doctor’s choice. This is a phase 3 trial, meaning it is testing the treatment in a larger group of patients to confirm its benefits and safety.
During the study, patients will receive their assigned treatment in repeated cycles, typically every few weeks, with regular hospital visits for medication administration, safety checks, and imaging scans to monitor the cancer. The study will continue until the disease progresses, unacceptable side effects occur, or the patient chooses to stop.
1registration and baseline assessment
after joining the study you will be assigned a study identification number and your medical information will be recorded.
baseline assessments will include physical examination, blood tests, and imaging studies to document the extent of small cell lung cancer.
2randomization to treatment group
the study will randomly assign you to receive either the test drug z l-1310 or the comparator therapy topotecan hydrochloride chosen by the investigator.
3initial treatment administration
if you are assigned to the test drug, you will receive z l-1310 as an intravenous infusion at a dose of 1.60 mg per kilogram of body weight on the first day of the treatment cycle.
if you are assigned to the comparator, you may receive topotecan hydrochloride either orally at 2.30 mg per square meter of body surface area or intravenously at 1.50 mg per square meter, according to the investigator’s choice.
4treatment cycles
treatment will be given in repeated cycles as directed by the investigator.
each cycle will include the administration of the assigned medication followed by a period of observation during which you will be monitored for side effects and disease status.
5regular monitoring visits
during each cycle you will attend clinic visits for blood tests, physical examinations, and questionnaires about symptoms and quality of life.
imaging studies will be performed at scheduled intervals to evaluate tumor response.
6response assessment
tumor response will be measured using standardized criteria (recist version 1.1) by an independent review.
the primary outcomes are the confirmed objective response rate and overall survival.
7dose adjustments and safety evaluation
if side effects of grade 3 or higher occur, the investigator may adjust the dose or temporarily pause treatment.
all adverse events will be recorded and graded according to standard criteria.
8continuation or discontinuation of treatment
treatment will continue until disease progression, unacceptable toxicity, or completion of the planned number of cycles as defined in the protocol.
9end of treatment and follow‑up
after stopping the study medication you will enter a follow‑up period during which periodic assessments will be performed to monitor survival and long‑term safety.
Who Can Join the Study?
Have Small Cell Lung Cancer that has been confirmed by looking at tissue under a microscope (histologically) or by examining cells (cytologically).
Have already received a first‑line (1L) chemotherapy that contains a platinum drug (platinum‑based) and may include a special immune medicine called an anti‑PD‑(L)1 agent. The cancer must have gotten worse during or after this treatment. If you cannot receive the immune medicine, that is allowed. Ongoing maintenance therapy with these drugs does not count as a new line of treatment. For limited‑stage disease, the first‑line treatment is counted if the cancer progressed within 6 months after finishing the platinum chemo. No second‑line therapy is allowed except for a drug named tarlatamab.
Have tumors that can be measured on scans using the standard criteria called RECIST v1.1.
If you have cancer that spread to the brain or nervous system (CNS metastases) and it has already been treated and is now stable, you are eligible.
If you have untreated brain spread that causes no symptoms, you must not need steroids, seizure medicines (anti‑convulsants), or local treatment such as radiation or surgery.
Have an ECOG performance status of 0 or 1, which means you are fully active (0) or able to carry out light work (1) despite your illness.
Be expected to live at least 3 months.
Show adequate function of major organs (like liver and kidneys) and bone‑marrow health, as shown by blood tests.
Be willing to have a new tumor sample taken (tumor biopsy) or to give a previously stored tumor tissue sample for the study.
Who Cannot Join the Study?
Have received more than one line of systemic therapy (treatment that travels throughout the whole body) for small cell lung cancer, except for the drug tarlatamab.
Have taken any prior ADC (antibody‑drug conjugate, a special type of cancer medicine) that contains a topoisomerase I inhibitor (a drug that blocks the copying of DNA).
Have a history of non‑infectious ILD/pneumonitis (lung inflammation not caused by infection) that required corticosteroids (steroid medicines), currently have ILD/pneumonitis of any severity, or have suspected ILD/pneumonitis that cannot be ruled out by imaging scans.
Have severe lung problems, such as an oxygen saturation below 90% on room air, caused by other lung diseases, autoimmune or inflammatory disorders, have had a lung removal (pneumonectomy) that leaves them with severe lung limitation, or need continuous supplemental oxygen.
Have received radiotherapy (radiation treatment) to any non‑chest area within the past 2 weeks, or to the chest (thoracic area) within the past 4 weeks, or have received more than 30 Gy (a unit measuring radiation dose) to the chest before the first study dose.
ZL-1310 is an experimental medicine that combines an antibody targeting a protein called DLL3 with a chemotherapy payload. In the study it is given through a vein (IV) as an infusion. The goal of ZL‑1310 is to deliver the chemotherapy directly to cancer cells that have DLL3, hoping to kill the tumor while reducing side effects to normal tissue.
Topotecan hydrochloride is a chemotherapy drug that is already used to treat small cell lung cancer. In the trial it can be given either as a pill you swallow (oral) or through a vein (IV), depending on the doctor’s choice. It works by stopping cancer cells from copying their DNA, which slows or stops tumor growth. In this study it serves as the standard treatment against which the new drug ZL‑1310 is compared.
Small Cell Lung Cancer (SCLC) – Small Cell Lung Cancer (SCLC) is a fast‑growing type of lung cancer that begins in cells lining the airways. It often spreads quickly to nearby lymph nodes and other organs such as the brain, liver, and bones. The disease may start with a small tumor that enlarges rapidly, causing coughing, shortness of breath, or chest pain. As it progresses, cancer cells can invade surrounding tissues and enter the bloodstream, leading to new tumor sites. The rapid growth and early spread are characteristic features of this disease.
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