Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer

Part of paid clinical trials in Monterey, California.

Sponsor
N-Power Medicine
Study ID
NCT07028489
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jun 19, 2025
Start date
Jun 5, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Osimertinib plus chemo, or other regimens
    Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024
  • Arm: Osimertinib monotherapy
    Osimertinib monotherapy for newly diagnosed mNSCLC

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) ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Pacific Cancer CareMontereyCalifornia93940
Study Coordinator
[email protected]
831-375-4105
Michael Z Koontz, MD (PRINCIPAL_INVESTIGATOR)
Torrance Memorial Physician Network-Cancer CareTorranceCalifornia90505
Clinical Research Coordinator
[email protected]
310-750-3300
Swati Skiaria, MD (PRINCIPAL_INVESTIGATOR)
John Muir HealthWalnut CreekCalifornia94598
Suzanne Clinical Research Coordinator
[email protected]
925-692-5603
GiGi Chen, MD (PRINCIPAL_INVESTIGATOR)
Bayhealth Cancer Center- KentDoverDelaware19901
Stephanie McClellan
[email protected]
302-744-7995
Iftekar Kahn, MD (PRINCIPAL_INVESTIGATOR)
Bayhealth Cancer Center- SussexMilfordDelaware19963
Stephanie McClellan
[email protected]
302-744-7995
Kootenai Clinic Cancer Services Coeur d'AleneCoeur d'AleneIdaho83814
Clinical Research Coordinator
[email protected]
1-208-725-3522
Jeffrey Allen, MD (PRINCIPAL_INVESTIGATOR)
Northwest Oncology & HematologyElk Grove VillageIllinois60007
Nowsheen Azeemuddin
[email protected]
8474373312
Lankenau Medical CenterPaoliPennsylvania19301
Jessica Burrell
[email protected]
484-476-2649
Paul Gilman, MD (PRINCIPAL_INVESTIGATOR)
Oncology Consultants, P.A.HoustonTexas77030
Research Office
[email protected]
713-600-0913
1-833-4NPM-REG

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