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Study of Osimertinib With and Without Ramucirumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03909334 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-17

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the efficacy of osimertinib plus ramucirumab versus osimertinib alone using progression free survival (PFS). Events associated with PFS include: disease progression per RECIST 1.1 and death due to any cause. A total of 150 patients will be enrolled and randomized in a 2:1 fashion (osimertinib plus ramucirumab vs. osimertinib) to the two treatment arms according to the following stratification factors: types of epidermal growth factor receptor (EGFR) mutations and presence of brain metastasis.

Conditions

Interventions

DRUG

Osimertinib

Osimertinib 80 mg orally on Day 1

DRUG

Ramucirumab

Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Eli Lilly and Company

    collaborator INDUSTRY

  • Xiuning Le

    lead OTHER

Principal Investigators

  • Xiuning Le, MD PhD · MD Anderson

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2026-12-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909334 on ClinicalTrials.gov