NCT02934503

Study of Pembrolizumab and Chemotherapy With or Without Radiation in Small Cell Lung Cancer (SCLC)

A Phase II Study of Pembrolizumab and Dynamic PD-L1 Expression in Extensive Stage Small Cell Lung Cancer (SCLC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This trial is to assess the efficacy of pembrolizumab added to concurrent chemotherapy with or without radiation therapy in patients with small cell lung cancer (SCLC).

Detailed description

SCLC provides an opportune setting to evaluate the potential importance of variability in PD-L1 expression and its influence on optimizing timing and efficacy of checkpoint inhibition. All extensive stage SCLC patients are treated with chemotherapy and recent data suggests added benefit to consolidation thoracic radiation. A prior study of patients with known PD-L1 expression showed a 35% response rate. That study used archival specimens and found a 29% PD-L1 positivity rate (at 1% level) suggesting that the expression level and prevalence could be higher (and response rate/outcome therefore potentially better) in patients who have previously had chemotherapy or radiation. The proposed study seeks to evaluate pembrolizumab therapy initiated at different times during the course of SCLC treatment: a) up front, in conjunction with initiation of chemotherapy, b) starting after one cycle of chemotherapy, c) starting after completion of 1st line chemotherapy (4-6 cycles), d) starting after completion of consolidation thoracic radiation therapy and/or prophylactic cranial irradiation (PCI). Treatment with pembrolizumab will be preceded by biopsy for evaluation of PD-L1 expression with correlative evaluation of changes in PD-L1 expression (relative to diagnostic biopsy) and changes in other tissue- and blood-based biomarkers and immune markers.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab	200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.
DRUG	Cisplatin	75 mg/m2
DRUG	Carboplatin	AUC 6
DRUG	Etoposide	IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).
RADIATION	Radiation therapy	Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants).

Timeline

• Start date: 2017-01-23
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2016-10-17
• Last updated: 2021-11-16
• Results posted: 2021-11-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study