Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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 augusti 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

530

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ZL-1310 in Combination with Checkpoint Inhibitor
ZL-1310 ADC in combination with checkpoint inhibitor
Aktiv komparator: 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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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]).
Tidsram: 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
Tidsram: 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
Tidsram: up to approximately 3 years
up to approximately 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

31 december 2026

Primärt slutförande (Beräknad)

30 juni 2030

Avslutad studie (Beräknad)

30 juni 2031

Studieregistreringsdatum

Först inskickad

24 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

26 augusti 2026

Första postat (Faktisk)

31 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera