Plasma-Adapted First-Line Pembro In NSCLC

NSCLC Stage IV Clinical Trial

Official title: Pilot Study of Serial Plasma Genotyping to Guide the Adaptive Treatment of Advanced NSCLC Receiving First-line Pembrolizumab

Status Active, not recruiting

Clinical Trial Summary

This research study is studying to see if a blood test, collected at different times during the treatment of metastatic non-small lung cancer, can be used to detect early response in patients being treated with pembrolizumab and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.

The names of the study drugs involved in this study are:

• Pembrolizumab

• Platinum doublet chemotherapy, which may include the following:

• Carboplatin and pemetrexed

• Carboplatin and paclitaxel

The name of the blood test:

• InVision (Inivata, Ltd.)

Clinical Trial Description

This is an open label, single institution, prospective pilot study.

The purpose of this research study is to determine if a blood test, collected at different times during treatment, can be used to detect early response in patients being treated with pembrolizumab for lung cancer and use that information to determine whether patients should continue treatment with pembrolizumab or switch treatment to pembrolizumab in combination with chemotherapy.

-The research study procedures include screening for eligibility and study treatment including evaluations approximately every 3 weeks.

The names of the study drugs involved in this study are:

• Pembrolizumab

• Platinum doublet chemotherapy, which may include the following:

• Carboplatin and pemetrexed

• Carboplatin and paclitaxel

The name of the blood test:

• InVision- Inivata

• This blood test that will help study how participants respond to the study treatment. ---

• Blood will be collected for this test at a few time points, both before and after participants receive treatment on study.

• Participants will be on the research study for up to 12 months.

• It is expected that about 40 people will take part in this research study. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Metastatic Non-Small Cell Lung Cancer
• NSCLC Stage IV

• NCT number: NCT04166487
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: January 13, 2020
• Completion date: December 1, 2024