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

NCT07796100 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: ZL-1310-005
• Study Type: interventional
• Target: 530
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Extensive-Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival of ZL-1310 with IO compared to chemo with IO

  up to approximately 3 years

Secondary Outcomes (12)

• 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

  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

  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

  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

  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

  up to approximately 3 years

Study Arms (2)

ZL-1310 in Combination with Checkpoint Inhibitor

EXPERIMENTAL

Combination Product: ZL-1310 in combination with Atezolizumab or Durvalumab

Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor

ACTIVE COMPARATOR

Combination Product: Carboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin; Combination Product: Carboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance

Interventions

ZL-1310 in combination with Atezolizumab or Durvalumab COMBINATION_PRODUCT

ZL-1310 ADC in combination with checkpoint inhibitor

ZL-1310 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

Standard of Care Platinum-based Chemotherapy 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

Standard of Care Platinum-based Chemotherapy with a Checkpoint Inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zai Lab (Shanghai) Co., Ltd.: lead
• Zai Lab (US) LLC: collaborator

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

atezolizumab; durvalumab; Carboplatin; Etoposide; PM 01183

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Central Study Contacts

ZL-1310-005 Study Team

CONTACT

650-360-1601; Study-ZL-1310-005@zailaboratory.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): December 31, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share