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Completed

NCT Number: NCT04180176

Prospective Clinicogenomic Program

The main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mNSCLC) or extensive-stage small-cell lung cancer (ES-SCLC) planning to start standard-of-care (SOC) systemic anti-cancer treatment. The study will also examine ctDNA status over the course of treatment as a predictor of response to therapy.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Small-Cell Lung Cancer (SCLC) Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alabama Oncology, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of mNSCLC or ES-SCLC
  • Planned initiation of SOC systemic anti-cancer treatment
  • Front-Line Immunotherapy Cohort: Received front-line treatment of an immune blockade therapy including anti-CTLA-4, anti-PD-1, or anti-PD-L1 therapeutic antibody on Protocol GX41563

Exclusion criteria

  • Participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent

Treatment and study plan

Blood Draw

Other

Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.

Primary outcomes

  1. Proportion of Potential Eligible Participant Enrollment

    Time frame: Up to 5 years

  2. Proportion of Enrolled Participants Submitting Sufficient Blood Samples

    Time frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Secondary outcomes

  1. Blood Level of ctDNA

    Time frame: At enrollment, then at pre-defined intervals from the first tumor assessment until disease assessment or end of therapy, whichever comes first, for up to 5 years.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Collaborators

  • Flatiron Health, Inc.; Foundation Medicine, Inc.

Registry information

Official study title

A Multicenter, Low-Interventional Study to Evaluate the Feasibility of a Prospective Clinicogenomic Program

Acronym: PCG

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 27, 2019
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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