Study of Osimertinib With and Without Ramucirumab in Advanced Non-Small Cell Lung Cancer

Sponsor: Xiuning Le

Sponsor score: 0

ClinicalTrials ID:NCT03909334

This clinical trial is testing whether adding the drug ramucirumab to osimertinib can improve outcomes for patients with advanced non-small cell lung cancer (NSCLC). The study will compare the effectiveness of the combination treatment against osimertinib alone in slowing down the progression of the disease.

Patient Parameters

Program Overview

The main goal of this study is to see if combining two drugs, osimertinib and ramucirumab, is more effective than using osimertinib alone in treating advanced non-small cell lung cancer (NSCLC). Researchers will measure how long patients live without the cancer getting worse. A total of 150 patients will participate, with two-thirds receiving both drugs and one-third receiving only osimertinib. The study will consider factors like specific genetic mutations and whether the cancer has spread to the brain.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and authorization to use personal health information.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of non-squamous, non-small cell lung cancer.
  • Cancer must be advanced or has spread and cannot be treated with surgery or radiation.
  • Must have specific genetic mutations in the EGFR gene.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have measurable cancer according to specific criteria.
  • If cancer has spread to the brain, it must be stable and not causing symptoms.
  • Must be able to swallow pills.
  • Previous chemotherapy or immunotherapy is allowed.
  • Must have adequate blood, liver, and kidney function based on recent lab tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Men must agree to use contraception if sexually active with a woman of childbearing potential.

Exclusion Criteria

  • Cannot take certain medications that affect heart rhythm or liver enzymes.
  • Cannot have had another cancer in the past two years, except for certain skin cancers and other specific conditions.
  • Cannot have been treated with certain cancer drugs before.
  • Cannot have unresolved side effects from previous treatments.
  • Cannot have uncontrolled health conditions, including high blood pressure or active infections.
  • Cannot have severe nausea, vomiting, or digestive issues that prevent taking medication by mouth.
  • Cannot have a history of lung disease or severe allergic reactions to study drugs.
  • Cannot have certain heart conditions or recent heart-related events.
  • Cannot have had significant bleeding or blood clots recently.
  • Cannot have severe liver disease or recent major surgery.

Locations

FACILITYZIPCITYSTATE
Georgetown University20057Washington D.C.District of Columbia
Moffitt Cancer Center33612TampaFlorida
Northwestern University Feinberg School of Medicine60611ChicagoIllinois
Rush University Medical Center60612ChicagoIllinois
Indiana Univesity Melvin and Bren Simon Cancer Center46202IndianapolisIndiana
Summit Medical Group, PA07922Berkeley HeightsNew Jersey
New York University Cancer Center10016New YorkNew York
Columbia University Irving Medical Center10032New YorkNew York
Providence Portland Medical Center97213PortlandOregon
MD Anderson Cancer Center77030HoustonTexas

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