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A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer

NCT04351555 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2025-05-23

No results posted yet for this study

Summary

This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer

Conditions

Interventions

DRUG

Osimertinib

Oral

DRUG

Cisplatin

Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.

DRUG

Carboplatin

Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles

DRUG

Placebo

Oral

DRUG

Pemetrexed

Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles

Sponsors & Collaborators

Principal Investigators

  • Jamie Chaft, MD · Memorial Sloan Kettering, USA

  • Masahiro Tsuboi, MD · National Cancer Center Hospital East, Japan

  • Walter Weder, MD · Thoraxchirurgie Bethanien, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2024-10-15
Completion
2029-06-13
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • China
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

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 NCT04351555 on ClinicalTrials.gov