Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change (NCT03191149)

🧪 Interventions in This Study

• Osimertinib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)
2. Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria
3. An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay
4. NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports
5. Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration
6. Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed
7. Participants must not have previously received osimertinib
8. Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration
9. Age \>= 18 years
10. Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
11. Hemoglobin \>= 9.0 g/L (within 4 weeks before registration)
12. Leukocytes/white blood cells \>= 3,000/mcL (within 4 weeks before registration)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (344 Sites)

Showing the first 25 of 344 sites.

• Anchorage Associates in Radiation Medicine — Anchorage, Alaska
• Anchorage Radiation Therapy Center — Anchorage, Alaska
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska
• Alaska Oncology and Hematology LLC — Anchorage, Alaska
• Alaska Women's Cancer Care — Anchorage, Alaska
• Anchorage Oncology Centre — Anchorage, Alaska
• Katmai Oncology Group — Anchorage, Alaska
• Providence Alaska Medical Center — Anchorage, Alaska
• Fairbanks Memorial Hospital — Fairbanks, Alaska
• Mercy Hospital Fort Smith — Fort Smith, Arkansas
• CARTI Cancer Center — Little Rock, Arkansas
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia
• Holy Cross Hospital — Fort Lauderdale, Florida
• Emory University Hospital Midtown — Atlanta, Georgia
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Emory Saint Joseph's Hospital — Atlanta, Georgia
• Saint Alphonsus Cancer Care Center-Boise — Boise, Idaho
• Saint Luke's Cancer Institute - Boise — Boise, Idaho
• Saint Alphonsus Cancer Care Center-Caldwell — Caldwell, Idaho
• Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho
• Walter Knox Memorial Hospital — Emmett, Idaho
• Saint Luke's Cancer Institute - Fruitland — Fruitland, Idaho
• Idaho Urologic Institute-Meridian — Meridian, Idaho
• Saint Luke's Cancer Institute - Meridian — Meridian, Idaho

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Advanced Lung Non-Small Cell Carcinoma

• Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer — Duarte, California
• Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy — Atlanta, Georgia
• Telaglenastat Hydrochloride and Osimertinib in Treating Patients With EGFR-Mutated Stage IV Non-small Cell Lung Cancer — Birmingham, Alabama
• GT103 in Combination With Pembrolizumab for the Treatment of Advanced or Metastatic STK11 Mutant Non-Small Cell Lung Cancer — Buffalo, New York
• MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cell Lung Cancer — Atlanta, Georgia

Explore by condition: All Advanced Lung Non-Small Cell Carcinoma clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.