Extensive-Stage Small Cell Lung Cancer
Conditions
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.
Interventions
COMBINATION_PRODUCTZL-1310 in combination with Atezolizumab or Durvalumab
ZL-1310 ADC in combination with checkpoint inhibitor
COMBINATION_PRODUCTCarboplatin/Etoposide in Combination with Atezolizumab followed by maintenance Atezolizumab with Lurbinectedin
Platinum-based chemotherapy in combination with a checkpoint inhibitor
COMBINATION_PRODUCTCarboplatin/Etoposide or Cistplatin/Etoposide in Combination with Durvalumab induction followed by Durvalumab maintenance
Standard of Care Platinum-based chemotherapy in combination
Sponsors
Zai Lab (Shanghai) Co., Ltd.
Zai Lab (US) LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of ZL-1310 with IO compared to chemo with IO | up to approximately 3 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 | 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 | up to approximately 3 years |
| Time to first onset of new brain metastases in participants without baseline brain metastases of ZL-130 | 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) | 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]). | 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 | 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 | up to approximately 3 years |
Contacts
CONTACTZL-1310-005 Study Team
Outcome results
None listed