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A Study of ZL-1310 in Combination With a Checkpoint Inhibitor Versus Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer

26 augustus 2026 bijgewerkt door: Zai Lab (Shanghai) Co., Ltd.

A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody-drug Conjugate (ADC) in Combination With a Checkpoint Inhibitor Compared to Standard of Care Platinum Based Chemotherapy With a Checkpoint Inhibitor as First-line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of ZL-1310 in combination with a checkpoint inhibitor compared to standard first-line therapy in participants with Extensive-Stage Small Cell Lung Cancer.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

530

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Histologically or cytologically confirmed ES-SCLC
  • No prior systemic therapy has been received
  • Medically eligible to receive standard platinum-based chemotherapy with atezolizumab or durvalumab as first-line therapy
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Adequate organ and marrow function

Exclusion Criteria:

  • Has a contraindication to receive atezolizumab or durvalumab according to local drug label or local treatment guideline
  • Participants with symptomatic CNS metastases (require initiation or dose change of steroids or anti-convulsant within 7 days prior to randomization; require steroid dose higher that prednisone 10 mg/day or equivalent within 14 days prior to randomization
  • History of ILD/pnuemonitis (non-infectious) that required corticosteroids, current ILD/pnuemonitis of any grade, or suspected ILD/pnuemonitis that cannot be ruled out by imaging at screening
  • Received radiotherapy within 2 weeks to the non-thoracic and within 4 weeks to the thoracic area prior to the first dose of study treatment or received more than 30 Gy of thoracic radiotherapy
  • Clinically significant active cardiovascular disease or history of any arterial thromboembolic event within 6 months prior to the first dose of study treatment
  • Clinically severe pulmonary compromise (including but not limited to baseline oxygen saturation of <90% on room air) resulting from intercurrent pulmonary illnesses
  • Major surgery within 4 weeks prior to the first dose of study treatment.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: ZL-1310 in Combination with Checkpoint Inhibitor
ZL-1310 ADC in combination with checkpoint inhibitor
Actieve vergelijker: Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor
Platinum-based chemotherapy in combination with a checkpoint inhibitor
Standard of Care Platinum-based chemotherapy in combination

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Overall survival of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Confirmed objective response rate (ORR) assessed by BICR and by investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Time to response (TTR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Confirmed central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Duration of central nervous system response assessed by BICR and by the investigator per modified Response Assessment in Neuro-Oncology for Brain Metastases in participants with brain metastases at baseline of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ-5D-5L index)
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EQ-5D (EQ visual analog scale [VAS]).
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13
Tijdsspanne: up to approximately 3 years
up to approximately 3 years
Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30
Tijdsspanne: up to approximately 3 years
up to approximately 3 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 december 2026

Primaire voltooiing (Geschat)

30 juni 2030

Studie voltooiing (Geschat)

30 juni 2031

Studieregistratiedata

Eerst ingediend

24 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 augustus 2026

Eerst geplaatst (Werkelijk)

31 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

26 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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