Non Small Cell Lung CancerNCT07028489
Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
An observational study of Non Small Cell Lung Cancer, run by N-Power Medicine at 10 sites in United States.
Trial summary
The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. 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
- 130 participants
- Where
- 10 sitesUnited States
- Study dates
- 5 Jun 2025to Apr 2029
- 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: All patients diagnosed with EGFR mutant locally advanced or metastatic NSCLC diagnosed from Jan 1st 2024 until the enrollment period ends.
Who may be able to join
- Be ≥18 years of age at the time of informed consent
- Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.
Who cannot join
- ECOG≥2 at diagnosis of advanced or metastatic NSCLC
- Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109
505-842-8171, valeriet@nmohc.com
Robert Lin, MD
- Recruiting
Kootenai Clinic Cancer Services Coeur d'Alene
Coeur d'Alene, Idaho, 83814
Clinical Research Coordinator, 1-208-725-3522, ebrewer@kh.org
Jeffrey Allen, MD
- Recruiting
Bayhealth Cancer Center- Kent
Dover, Delaware, 19901
Stephanie McClellan, 302-744-7995, Clinical_trials@bayhealth.org
Iftekar Kahn, MD
- Recruiting
Northwest Oncology & Hematology
Elk Grove Village, Illinois, 60007
Nowsheen Azeemuddin, 8474373312, nowsheena@northwestoncology.com
- Recruiting
Oncology Consultants, P.A.
Houston, Texas, 77030
Research Office, 713-600-0913, support@npowermedicine.com
1-833-4NPM-REG
- Recruiting
Bayhealth Cancer Center- Sussex
Milford, Delaware, 19963
Stephanie McClellan, 302-744-7995, Clinical_trials@bayhealth.org
- Recruiting
Pacific Cancer Care
Monterey, California, 93940
Study Coordinator, 831-375-4105, alexanderbaskoro@npowermedicine.com
Michael Z Koontz, MD
- Not yet recruiting
Lankenau Medical Center
Paoli, Pennsylvania, 19301
Jessica Burrell, 484-476-2649, burrellje@mlhs.org
Paul Gilman, MD
- Recruiting
Torrance Memorial Physician Network-Cancer Care
Torrance, California, 90505
Clinical Research Coordinator, 310-750-3300, clinical-trials@tmphysicians.com
Swati Skiaria, MD
- Recruiting
John Muir Health
Walnut Creek, California, 94598
Suzanne Clinical Research Coordinator, 925-692-5603, suzanne.brennan@johnmuirhealth.com
GiGi Chen, MD
About this study
The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (~30%) will undergo imaging with standardized intervals.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- metastatic, advanced
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
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 |
|---|---|---|
| Osimertinib plus chemo, or other regimens | Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024 | |
| Osimertinib monotherapy | Osimertinib monotherapy for newly diagnosed mNSCLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Measured: From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)
Secondary outcomes (2)
Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Measured: From the index date (date of initiation of first line treatment for metastatic disease) until death, as assessed up to 100 months
Assess time to treatment discontinuation in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Measured: From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start5 Jun 2025
- Primary completionDec 2028 (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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N-Power Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028489
- Sponsor's protocol ID
- NPM-002
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 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
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
- Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07028489
- Acronym / sponsor ID
- NPM-002
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- metastatic, advanced
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- N-Power MedicineIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 19 Jun 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.
The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (~30%) will undergo imaging with standardized intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osimertinib plus chemo, or other regimens | – | –Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024 |
| Osimertinib monotherapy | – | –Osimertinib monotherapy for newly diagnosed mNSCLC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with EGFR mutant locally advanced or metastatic NSCLC diagnosed from Jan 1st 2024 until the enrollment period ends.
Key inclusion criteria (2 listed)
- Be ≥18 years of age at the time of informed consent
- Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.
Key exclusion criteria (2 listed)
- ECOG≥2 at diagnosis of advanced or metastatic NSCLC
- Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.
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 real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)
2 secondary outcomes
Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until death, as assessed up to 100 months
Assess time to treatment discontinuation in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
Time frame: From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months
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
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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.
10 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 10 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 2 inclusion and 2 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 10 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?
Contact N-Power Medicine Support (1-833-467-6734, support@npowermedicine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib (time frame: From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)). 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.