NCT04166487

Plasma-Adapted First-Line Pembro In NSCLC

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Julia K. Rotow, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.)

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pembrolizumab	predetermined dose, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
DRUG	PEMETREXED	administered per standard practice, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
DRUG	CARBOPLATIN	administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
DRUG	PACLITAXEL	administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
DIAGNOSTIC_TEST	InVision	Plasma draw for clinical test performed at C1D1 and C2D1; plasma draw for research testing performed at other timepoints per protocol.

Timeline

• Start date: 2020-01-13
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2019-11-18
• Last updated: 2026-01-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study