An External Control Arm Study in Non-Sm… | Clinical Trial

Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Cancer Care, Monterey, California, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

> 18 years of age at the time of informed consent
Pathologically confirmed locally advanced or metastatic NSCLC
ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.
Life expectancy of more than 3 months
Able to understand and sign informed consent
Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)

*see protocol for cohort specific inclusion criteria*

Exclusion criteria

Actively on a clinical trial of an investigational agent
Currently receiving active systemic therapy for another malignancy
Eligible for treatment with curative intent

*see protocol for cohort specific exclusion criteria*

Treatment and study plan

Primary outcomes

Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies

Time frame: September 2025-April 2029

Secondary outcomes

Assess Progression Free Survival (PFS), Overall Survival (OS), and Time to Next Treatment (TTNT) by cohort in patients with metastatic NSCLC initiating second or third line treatment with NCCN recommended therapies.

Time frame: September 2025-April2029

Sponsors and collaborators

Lead sponsor

N-Power Medicine

Industry

Registry information

Official study title

A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Sep 15, 2025
Registry last updated: Aug 10, 2026

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.

Published trials that share one or more normalized conditions with this study.

Recruiting