Osimertinib, Surgery, and Radiation Therapy in Treating Patients With Stage IIIB or IV Non-small Cell Lung Cancer With EGFR Mutations, NORTHSTAR Study

Part of paid clinical trials in San Francisco, California.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03410043
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lung Non-Small Cell Carcinoma
  • Recurrent Lung Non-Small Cell Carcinoma
  • Stage IIIB Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Given PO
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo surgery

Study Details

This phase II trial studies how well osimertinib, surgery, and radiation therapy work in treating patients with stage IIIB or IV non-small cell lung cancer with EGFR mutations. Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving osimertinib, surgery, and radiation therapy may work better at treating non-small cell lung cancer with EGFR mutations.

Key Dates

Start date
Jan 17, 2018
Status verified
Apr 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
173 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (LCT)
    Patients receive osimertinib PO QD for 6-12 weeks. Patients then undergo surgery and/or radiation therapy daily for 5 consecutive days every week for up to 8 weeks. Patients continue osimertinib during and after radiation therapy. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
  • Experimental: Group II (no LCT)
    Patients receive osimertinib PO QD. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From the start date of osimertinib assessed up to 4 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
UCSF Medical Center-Mount ZionSan FranciscoCalifornia94115-
University of ColoradoDenverColorado80217-3364-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in San Francisco, CA

By research site
UCSF Medical Center-Mount Zion· San Francisco, CAUniversity of Colorado· Denver, COMemorial Sloan Kettering Cancer Center· New York, NYM D Anderson Cancer Center· Houston, TX

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