Recruiting

Observational Study

Sponsor:

N-Power Medicine

Code:

NCT07174388

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Non Small Cell Lung Cancer

Study ID

NCT07174388

Start date

Jan 7, 2026

Status verified date

Aug, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. > 18 years of age at the time of informed consent
2. Pathologically confirmed locally advanced or metastatic NSCLC
3. ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.
4. Life expectancy of more than 3 months
5. Able to understand and sign informed consent
6. 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:

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

\*see protocol for cohort specific exclusion criteria\*

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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, 2024, or later, irrespective of line of therapy or current treatment.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Pacific Cancer Care

Recruiting

Monterey, California, United States, 93940

Contacts

Alexander Baskoro

831-375-4105alexanderbaskoro@npowermedicine.com

Principal Investigator:

Anushi Bulumulle, MD

Bayhealth Medical Center, Kent Campus

Recruiting

Dover, Delaware, United States, 19901

Contacts

Ruby Davis

302-744-7795Ruby_Davis@bayhealth.org

Principal Investigator:

Iftekhar Khan, MD

Bayhealth Medical Center- Sussex Campus

Recruiting

Milford, Delaware, United States, 19963

Contacts

Ruby Davis

Ruby_Davis@bayhealth.orgruby_davis@bayhealth.org

Principal Investigator:

Iftekhar Khan, MD

Northwest Oncology and Hematology

Recruiting

Barrington, Illinois, United States, 60010

Contacts

Nowsheen Azeemuddin

847-577-0620nowsheena@northwestoncology.com

Principal Investigator:

Roberto Montoya, MD

Northwest Oncology and Hematology

Recruiting

Elk Grove, Illinois, United States, 60008

Contacts

Nowsheen Azeemuddin

847-577-0620nowsheena@northwestoncology.com

Principal Investigator:

Roberto Montoya, MD

Northwest Oncology and Hematology

Recruiting

Hoffman Estates, Illinois, United States, 60169

Contacts

Nowsheen Azeemuddin

847-577-0620nowsheena@northwestoncology.com

Principal Investigator:

Roberto Montoya, MD

Northwest Oncology and Hematology

Recruiting

Rolling Meadows, Illinois, United States, 60008

Contacts

Nowsheen Azeemuddin

847-577-0620nowsheena@northwestoncology.com

Principal Investigator:

Roberto Montoya, MD

Oncology Consultants

Recruiting

Houston, Texas, United States, 77030

Contacts

Research Office

713-600-0913support@npowermedicine.com

Principal Investigator:

Luis Campos, MD

More Information

Sponsor

N-Power Medicine

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by N-Power Medicine on 2026-08-10.