MedTrace Logo

Plasma-Adapted First-Line Pembro In NSCLC

NCT04166487 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-21

No results posted yet for this study

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.)

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Inivata

    collaborator INDUSTRY

  • Julia K. Rotow, MD

    lead OTHER

Principal Investigators

  • Julia K Rotow, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2025-06-01
Completion
2026-12-01
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166487 on ClinicalTrials.gov