Study Comparing ZL-1310 to Other Treatments for Relapsed Small Cell Lung Cancer

Sponsor: Zai Lab (Shanghai) Co., Ltd.

Sponsor score: 0

ClinicalTrials ID:NCT07218146

This clinical trial is testing a new drug, ZL-1310, to see if it is safe and effective compared to other treatments chosen by doctors for patients with small cell lung cancer that has returned after initial treatment.

Patient Parameters

Program Overview

The aim of this study is to find out if the new drug ZL-1310 works better and is safer than other treatments chosen by doctors for patients whose small cell lung cancer has come back after previous treatment. Participants will receive either ZL-1310 or a treatment selected by their doctor, and researchers will monitor their health and the cancer's response to the treatment.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older, or considered an adult by local standards.
  • Have signed a consent form agreeing to participate.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Have received initial treatment with platinum-based chemotherapy and experienced cancer progression during or after this treatment, or have received a second-line treatment called tarlatamab.
  • Have measurable cancer according to specific medical criteria.
  • Have a history of treated and stable, or untreated and symptom-free, cancer spread to the brain or spinal cord.
  • Have good organ and bone marrow function.
  • 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.
  • Have a life expectancy of at least 3 months.
  • Be willing to undergo a tumor biopsy or provide a previous tumor sample.
  • Be willing and able to follow the study procedures for its duration.

Exclusion Criteria

  • Have received more than one line of treatment for extensive-stage small cell lung cancer.
  • Have previously received a specific type of drug called ADC with topoisomerase 1 inhibitor.
  • Have another type of cancer, with some exceptions.
  • Have a history or suspicion of lung diseases like interstitial lung disease or pneumonitis.
  • Have severe lung problems due to other lung illnesses.
  • Have received any cancer treatment within 3 weeks before starting the study treatment.
  • Have had prior radiation therapy before starting the study treatment, based on specific criteria.
  • Have unresolved side effects from previous cancer treatments, except for hair loss and skin color changes.
  • Have a known or active infection.
  • Have significant heart disease or a history of blood clots in the arteries within 6 months before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
Zai Lab Site 0204534711ClermontFlorida
Zai Lab Site 0203132763Orange CityFlorida
Zai Lab Site 0202634232SarasotaFlorida
Zai Lab Site 0201961615PeoriaIllinois
Zai Lab Site 0204961637PeoriaIllinois
Zai Lab Site 0204140202LouisvilleKentucky
Zai Lab Site 0200320817BethesdaMaryland
Zai Lab Site 0202365201ColumbiaMissouri
Zai Lab Site 0201919063MediaPennsylvania

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