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NCT Number: 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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZL-1310 in combination with Atezolizumab or Durvalumab

Combination Product

ZL-1310 ADC in combination with checkpoint inhibitor

Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin

Combination Product

Platinum-based chemotherapy in combination with a checkpoint inhibitor

Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance

Combination Product

Standard of Care Platinum-based chemotherapy in combination

Primary outcomes

  1. Overall survival of ZL-1310 with IO compared to chemo with IO

    Time frame: up to approximately 3 years

Secondary outcomes

  1. 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

    Time frame: up to approximately 3 years

  2. 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

    Time frame: up to approximately 3 years

  3. Duration of response (DoR) assessed by BICR and by the investigator per RECIST v1.1 of ZL-1310with IO compared to chemo with IO

    Time frame: up to approximately 3 years

  4. 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

    Time frame: up to approximately 3 years

  5. 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

    Time frame: up to approximately 3 years

  6. 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

    Time frame: up to approximately 3 years

  7. Incidence rate of new brain metastases in participants without baseline brain metastases of ZL-1310 with IO compared to chemo with IO

    Time frame: up to approximately 3 years

  8. Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130

    Time frame: up to approximately 3 years

  9. 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)

    Time frame: up to approximately 3 years

  10. 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]).

    Time frame: up to approximately 3 years

  11. Changes from baseline in quality of life related parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-LC13

    Time frame: up to approximately 3 years

  12. Changes from baseline in quality of life parameters of ZL-1310 with IO compared to chemo with IO using EORTC-QLQ-C30

    Time frame: up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

ZL-1310-005 Study Team

CONTACT

[email protected]

650-360-1601

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Collaborators

  • Zai Lab (US) LLC

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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