NCT02748889

Carboplatin Plus Etoposide With or Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer

An Open Label, Randomized Phase I/II Trial of Carboplatin Plus Etoposide With ot Without MPDL3280A in Untreated Extensive Stage Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Giuseppe Giaccone · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study with two parts, a Phase I study and a randomized Phase II study. This study will be conducted at approximately ten sites in the United States. Approximately 178 patients will be enrolled in this trial.

Detailed description

Combining standard chemotherapy with a PD-1/PD-L1 inhibitor holds great appeal in the treatment of SCLC. While this approach may be appropriate for many cancer types, SCLC may be particularly vulnerable to this treatment strategy. Early studies have suggested greater efficacy with agents targeting PD-1/PD-L1 in tumors that are more mutationally complex, such as those associated with tobacco use. SCLC has a strong association with tobacco use and indeed, genome-wide sequencing studies have consistently shown that SCLC carries one of the highest rates of non-synonymous mutations. In addition, MPDL3280A has been safely combined with platinum based chemotherapy doublets in the treatment of NSCLC. Thus, a combination of carboplatin, etoposide and MPDL3280A may significantly improve outcomes in the treatment of SCLC.

Conditions

• Small Cell Lung Cancer ( SCLC )

Interventions

Type	Name	Description
DRUG	Carboplatin	Standard chemotherapy
DRUG	Etoposide	Standard chemotherapy
BIOLOGICAL	MPDL3280A	Experimental biologic

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-09
• Completion: 2017-05-09
• First posted: 2016-04-22
• Last updated: 2018-07-02
• Results posted: 2018-07-02

Locations

1 site across 1 country: United States