An External Control Arm Study in Non-Small Cell Lung Cancer

NCT07174388 | Recruiting

• 1 other identifier: NPM-004
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 8

Brief Summary

A study to create control arms using current and future information in patients with lung cancer.

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 (11)

Cohort 1

Patients starting first line therapy with ICI single/doublet or ICI in combination with a platinum doublet

Cohort 2

Patients with actionable EGFR mutations starting first line therapy

Cohort 3

Patients with KRAS G12D mutations (excluding KRAS G12C) starting any line of therapy

Cohort 4

Patients with PD-L1 (TPS) greater than or equal to 50% starting second line therapy, after previously being treated with single/doublet ICI or ICI in combination with a platinum doublet as first line treatment.

Cohort 5

Patients with PD-L1 (TPS) \< 50% starting second line therapy, after previously being treated with a platinum doublet in combination with ICI as first line treatment

Cohort 6

Patients without actionable tumor alterations in EGFR, ALK, or ROS 1 where PD-L1 status (TPS) is unknown, starting 2L therapy according to physician's choice

Cohort 7

Patients with KRAS G12C mutation starting second line therapy

Cohort 8

Patients with non-G12 KRAS mutations starting 2L therapy

Cohort 9

Patients with EGFR mutations starting second line or later line of therapy, after previously being treated with osimertinib monotherapy, osimertinib in combination with chemotherapy or lazertinib in combination with amivantamab

Cohort 10

Patients starting 3 line or later line anti-cancer therapy (and not eligible for any other cohort)

Cohort 11

Patients with EGFR exon 19del or EGFR exon 21 L858R locally advanced or metastatic NSCLC diagnosed on Jan 1st, 2025, or later, irrespective of line of therapy or current treatment.

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 qualify if:

• \> 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)

You may not qualify if:

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

Sponsors & Collaborators

• N-Power Medicine: lead

Study Sites (8)

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

Oncology Consultants

Houston, Texas, 77030, 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: June 16, 2026

Record last verified: 2026-06

Locations

US (8)