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Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers

NCT04410796 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 571

Last updated 2025-11-06

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic Non-small Cell Lung Cancer

Interventions

DRUG

Osimertinib

80mg orally daily

DRUG

Carboplatin

Carboplatin (AUC 5 IV q 3 weeks)

DRUG

Pemetrexed

Pemetrexed (500mg/m2 IV q 3 weeks) for a total of 4 cycles

Sponsors & Collaborators

Principal Investigators

  • Helena Yu, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-28
Primary Completion
2026-05-31
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT04410796 on ClinicalTrials.gov