A Study in Non-Small Cell Lung Cancer

NCT07174388 | Recruiting

• 1 other identifier: NPM-004
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 7

Brief Summary

A study to create control arms using current and future information in patients with lung cancer that has spread who have already received chemotherapy.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; External Control Arm; Non-Interventional; N-Power Medicine; Registry; Prospective

Outcome Measures

Primary Outcomes (1)

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

  September 2025-April 2029

Secondary Outcomes (1)

• 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.

  September 2025-April2029

Study Arms (9)

Cohort 1

Patients starting first line pembrolizumab or pembrolizumab in combination with a platinum doublet

Cohort 2

Patients with KRASG12D mutation starting first or later line of therapy

Cohort 3

Patients planned to have second line docetaxel or docetaxel in combination with ramucirumab with tumor without alterations in KRAS, EGFR, ALK, or ROS1

Cohort 4

Patients with PD-L1 \> 50% treated with single agent immuno-oncology therapy (IO) or dual IO agents as first line treatment.

Cohort 5

Patients with PD-L1 \< 50% without alterations in KRAS, EGFR, ALK, or ROS1

Cohort 6

Patients with documented KRAS G12C mutation

Cohort 7

Patients with non-G12C and non-G12D KRAS mutations

Cohort 8

Patients with EGFR mutations with prior treatment with osimertinib in combination with chemotherapy or lazertinib in combination with amivantamab

Cohort 9

Patients initiating single agent docetaxel or docetaxel and ramucirumab as third line of therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic NSCLC receiving first, second or third line NCCN recommended therapies

You may not qualify if:

• Unable to provide informed consent
• Actively on a clinical trial of an investigational agent

Sponsors & Collaborators

• N-Power Medicine: lead

Study Sites (7)

Pacific Cancer Care

Monterey, California, 93940, United States

RECRUITING

Bayhealth Medical Center, Kent Campus

Dover, Delaware, 19901, United States

RECRUITING

Bayhealth Medical Center- Sussex Campus

Milford, Delaware, 19963, United States

RECRUITING

Northwest Oncology and Hematology

Barrington, Illinois, 60010, United States

RECRUITING

Northwest Oncology and Hematology

Elk Grove, Illinois, 60008, United States

RECRUITING

Northwest Oncology and Hematology

Hoffman Estates, Illinois, 60169, United States

RECRUITING

Northwest Oncology and Hematology

Rolling Meadows, Illinois, 60008, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Optional submission of archived tissue when available. Should originate from a prior diagnostic biopsy or surgical resection. Provision of archived tissue is optional and not required for study eligibility, enrollment, or continued participation.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 15, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

US (7)