Who is eligible for clinical trial NCT04410796?

Participants must meet the protocol's inclusion criteria for Metastatic Non-small Cell Lung Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04410796 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers (NCT04410796)

A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (22 items) and avoid the listed exclusions (34 items).

Location: UC Davis Cancer Center (Data Collection Only) — Sacramento, California

Age range: 18 Years

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).

Usually NOT eligible if any of the following apply:

Exclusion Criteria: Initial
Pregnant or lactating women
Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.
Any evidence of clinically significant interstitial lung disease
Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater
Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.
Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy- related neuropathy
Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial
active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
Screening for chronic conditions is not required.
In patients with resolved or chronic hepatitis B infection (inactive carrier state) or active controlled HBV infection on treatment with osimertinib

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

📍 All Participating Trial Locations (18 Sites)

UC Davis Cancer Center (Data Collection Only) — Sacramento, California
University of California San Francisco — San Francisco, California
Moffitt Cancer Center — Tampa, Florida
John Hopkins Medical Center — Baltimore, Maryland
Massachusetts General Hospital (Data Collection Only) — Boston, Massachusetts
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey
Hackensack Meridian Health — Hackensack, New Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
Memorial Sloan Kettering Commack (Limited protocol activities) — Commack, New York
Memorial Sloan Kettering Westchester (Limited protocol activities) — Harrison, New York
New York University — New York, New York
Columbia University (Data Collection Only) — New York, New York
Memorial Sloan Kettering Cancer Center (All protocol activities) — New York, New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York
Sarah Cannon Research Institute — Nashville, Tennessee
MD ANDERSON CANCER CENTER (Data Collection Only) — Houston, Texas
University of Washington (Data Collection Only) — Seattle, Washington

📞 Contact the Study Coordinator

Phone: (646) 608-2252

Email: yuh@mskcc.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗