Non Small Cell Lung CancerNCT07174388
An External Control Arm Study in Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by N-Power Medicine at 11 sites in United States.
Trial summary
A study to create control arms using current and future information in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 650 participants
- Where
- 11 sitesUnited States
- Study dates
- 7 Jan 2026to Apr 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic NSCLC receiving first, second or third line NCCN recommended therapies
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
Research Operations Director, 505-842-8171, valeriet@nmohc.com
Robert Lin, MD
- Recruiting
Northwest Oncology and Hematology
Barrington, Illinois, 60010
Nowsheen Azeemuddin, 847-577-0620, nowsheena@northwestoncology.com
Roberto Montoya, MD
- Recruiting
Bayhealth Medical Center, Kent Campus
Dover, Delaware, 19901
Ruby Davis, 302-744-7795, Ruby_Davis@bayhealth.org
Iftekhar Khan, MD
- Recruiting
Northwest Oncology and Hematology
Elk Grove, Illinois, 60008
Nowsheen Azeemuddin, 847-577-0620, nowsheena@northwestoncology.com
Roberto Montoya, MD
- Recruiting
Northwest Oncology and Hematology
Hoffman Estates, Illinois, 60169
Nowsheen Azeemuddin, 847-577-0620, nowsheena@northwestoncology.com
Roberto Montoya, MD
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Research Office, 713-600-0913, support@npowermedicine.com
Luis Campos, MD
- Recruiting
Bayhealth Medical Center- Sussex Campus
Milford, Delaware, 19963
Ruby Davis, Ruby_Davis@bayhealth.org, ruby_davis@bayhealth.org
Iftekhar Khan, MD
- Recruiting
Pacific Cancer Care
Monterey, California, 93940
Alexander Baskoro, 831-375-4105, alexanderbaskoro@npowermedicine.com
Anushi Bulumulle, MD
- Recruiting
New York Cancer and Blood Specialists
New York, New York, 10033
Megan Stahl, 212-396-1174, mstahl@nycancer.com
Richard Zuniga, MD
- Recruiting
Northwest Oncology and Hematology
Rolling Meadows, Illinois, 60008
Nowsheen Azeemuddin, 847-577-0620, nowsheena@northwestoncology.com
Roberto Montoya, MD
- Recruiting
Main Line Health
Wynnewood, Pennsylvania, 19096
Jessica Burrell, 484-829-6003, burrellje@mlhs.org
Paul Gilman, MD
About this study
Official title: A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients
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
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies
Measured: 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.
Measured: September 2025-April2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start7 Jan 2026
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- N-Power Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174388
- Sponsor's protocol ID
- NPM-004
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT07174388
- Acronym / sponsor ID
- NPM-004
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, External Control Arm, Non-Interventional, N-Power Medicine, Registry, Prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- N-Power MedicineIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to create control arms using current and future information in patients with lung cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic NSCLC receiving first, second or third line NCCN recommended therapies
Key inclusion criteria (7 listed)
- > 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bayhealth Medical Center- Sussex Campus
Milford, United States
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by N-Power Medicine at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.