NCT03656094

Chemotherapy With Pembrolizumab Continuation After Progression to PD-1/L1 Inhibitors

Chemotherapy Plus Pembrolizumab After Progression With Previous PD-1/PD-L1 Inhibitors in Patients With Advanced Non-small Cell Lung Cancer: Placebo-controlled Randomized Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

After progression to previous PD-1/L1 inhibitors (pembrolizumab, nivolumab, or atezolizumab), physicians' choice chemotherapy plus pembolizumab (or placebo) will be administered (3 weeks per cycle) until disease progression or unacceptable toxicity.

Detailed description

Previous PD-1/PD-L1 inhibitors should be 2nd or 3rd line therapy for advanced NSCLC. There should be no systemic therapy after previous PD-1/PD-L1 therapy, before the enrollment to this study.

Conditions

• Non-small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Pembrolizumab plus chemotherapy	Pembrolizumab plus chemotherapy
DRUG	Placebo plus chemotherapy	Placebo plus chemotherapy

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-11-01
• Completion: 2021-11-01
• First posted: 2018-09-04
• Last updated: 2019-12-09

Locations

1 site across 1 country: South Korea