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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

ConditionExtensive-Stage Small Cell Lung Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorZai Lab (Shanghai) Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

530 Participants
are divided into 2 treatment groups
Group A: ZL-1310 in Combination with Checkpoint InhibitorExperimental treatment 1 intervention
Group B: Standard of Care Platinum-based Chemotherapy with a Checkpoint InhibitorActive comparator 2 interventions

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zai Lab (Shanghai) Co., Ltd.

Lead sponsor

Zai Lab (US) LLC

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: