- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07796100
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
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
- Kombinationsprodukt: ZL-1310 in combination with Atezolizumab or Durvalumab
- Kombinationsprodukt: Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin
- Kombinationsprodukt: Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance
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
- Namn: ZL-1310-005 Study Team
- Telefonnummer: 650-360-1601
- E-post: Study-ZL-1310-005@zailaboratory.com
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.
Sponsor
Samarbetspartners
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
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Luftvägssjukdomar
- Lungsjukdomar
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Småcelligt lungkarcinom
- Organiska kemikalier
- Kolväten
- Kolväten, cykliska
- Kolhydrater
- Podofyllotoxin
- Tetrahydronaftaler
- Naftalar
- Polycykliska aromatiska kolväten
- Kolväten, aromatisk
- Polycykliska föreningar
- Glukosider
- Glykosider
- Koordinationskomplex
- Etoposid
- Karboplatin
- PM 01183
- durvalumab
- atezolizumab
Andra studie-ID-nummer
- ZL-1310-005
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
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