Actively Recruiting
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-11-06
571
Participants Needed
18
Research Sites
309 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Biopsy-proven metastatic non-small cell lung cancer confirmed at enrolling institution
- Somatic activating EGFR mutation in tumor biopsy, pleural fluid cytology, or circulating tumor DNA
- No prior chemotherapy for metastatic disease; may have started osimertinib within 3 weeks of enrollment
- Measurable disease per RECIST 1.1 with at least one lesion not previously irradiated
- Karnofsky performance status 70% or higher
- Ability to swallow oral medications
- Adequate organ function with hemoglobin ≥ 9 g/dL, platelets ≥ 150,000/mm3, AST and ALT ≤ 2.5x upper limit of normal without liver metastases (or ≤ 5x with metastases), total bilirubin ≤ 1.5x upper limit of normal (or ≤ 3x with Gilbert's Syndrome or liver metastases), absolute neutrophil count ≥ 1500 cells/mm3, and creatinine clearance ≥ 60 mL/min
- Willingness to use effective contraception if of child-bearing potential
- Negative pregnancy test and not breastfeeding if female and of child-bearing potential
- Post-menopausal status or surgical sterilization if applicable
- Male subjects willing to use barrier contraception and avoid sperm donation during and after treatment
- Detectable EGFR mutations in plasma at cycle 2 day 1 for randomization phase
- Stable disease per RECIST 1.1 prior to starting chemotherapy
- Karnofsky performance status 70% or higher at randomization
- Adequate organ function at randomization with hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/mm3, creatinine clearance ≥ 60 mL/min, AST and ALT ≤ 3x upper limit of normal without liver metastases (or ≤ 5x with metastases), total bilirubin ≤ 1.5x upper limit of normal (or ≤ 3x with Gilbert's Syndrome or liver metastases), and absolute neutrophil count ≥ 1500 cells/mm3
You will not qualify if you...
- Pregnant or lactating women
- Radiotherapy within 1 week before starting treatment (if not yet on osimertinib)
- Major surgery within 2 weeks before starting treatment (if not yet on osimertinib)
- Clinically significant interstitial lung disease
- Treatment with investigational drug within five half-lives or 3 months before study
- Use of medications or supplements that strongly induce CYP3A4 and cannot be stopped
- Unresolved toxicity from prior therapy greater than grade 1, except alopecia and grade 2 neuropathy from prior platinum therapy
- Severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding disorders
- Active infections including hepatitis B, hepatitis C, or HIV
- History of interstitial lung disease or radiation pneumonitis requiring steroids
- Hypersensitivity to osimertinib or similar drugs
- QTc interval > 470 msec or significant heart rhythm abnormalities
- Factors increasing risk of QT prolongation or arrhythmias
- Inability to comply with study procedures or restrictions
- Refractory nausea, vomiting, chronic gastrointestinal diseases, or significant bowel surgery preventing absorption of osimertinib
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
UC Davis Cancer Center (Data Collection Only)
Sacramento, California, United States, 95817
Actively Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94143
Active, Not Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
John Hopkins Medical Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Massachusetts General Hospital (Data Collection Only)
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
7
Hackensack Meridian Health
Hackensack, New Jersey, United States, 07601
Actively Recruiting
8
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
9
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
10
Memorial Sloan Kettering Commack (Limited protocol activities)
Commack, New York, United States, 11725
Actively Recruiting
11
Memorial Sloan Kettering Westchester (Limited protocol activities)
Harrison, New York, United States, 10604
Actively Recruiting
12
New York University
New York, New York, United States, 10010
Actively Recruiting
13
Columbia University (Data Collection Only)
New York, New York, United States, 10032
Active, Not Recruiting
14
Memorial Sloan Kettering Cancer Center (All protocol activities)
New York, New York, United States, 10065
Actively Recruiting
15
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
16
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
17
MD ANDERSON CANCER CENTER (Data Collection Only)
Houston, Texas, United States, 77030
Actively Recruiting
18
University of Washington (Data Collection Only)
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
H
Helena Yu, MD
CONTACT
G
Gregory Riely, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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