Actively Recruiting
A Phase 2 Study Comparing Osimertinib Alone Versus Osimertinib Plus Chemotherapy for Metastatic EGFR-Mutant Lung Cancer with Detectable EGFR Mutations in Plasma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-06-03
571
Participants Needed
18
Research Sites
N/A
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
Researchers are evaluating treatments for metastatic non-small cell lung cancer with EGFR gene mutations. The study compares the usual treatment of osimertinib alone to a combination of osimertinib with chemotherapy drugs carboplatin and pemetrexed. This Phase 2 study aims to see if adding chemotherapy improves the control of cancer growth and spread in patients whose cancer has detectable EGFR mutations in their blood after starting osimertinib. Participants first receive osimertinib at a standard dose of 80mg orally each day during a screening period lasting three 21-day cycles. After this, patients with persistent EGFR mutations detected in their blood are randomly assigned to either continue osimertinib alone or receive osimertinib combined with carboplatin and pemetrexed chemotherapy given intravenously every three weeks for four cycles, followed by maintenance pemetrexed. Osimertinib treatment continues daily in both groups, and patients keep a pill diary starting at cycle 4. During the study, participants undergo regular assessments including tumor measurements and blood tests to monitor cancer and treatment effects. The main outcome measured is progression-free survival over two years. Researchers also track response rates and safety through clinical evaluations. The study includes follow-up to assess ongoing effects, with participation lasting as long as the treatment and monitoring periods extend.
CONDITIONS
Brief 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 confirmed in tumor or fluid samples
- No prior chemotherapy for metastatic disease; osimertinib start allowed within 3 weeks
- Measurable disease by RECIST 1.1 criteria not previously treated with radiation
- Karnofsky performance status of 70% or higher
- Ability to swallow oral medications
- Adequate organ function including hemoglobin ≥ 9 g/dL, platelets ≥ 150,000/mm3, AST and ALT ≤ 2.5x upper limit without liver metastases
- Total bilirubin ≤ 1.5x upper limit without liver metastases
- Absolute neutrophil count ≥ 1500 cells/mm3
- Creatinine clearance ≥ 60 ml/min
- Willingness to use effective contraception if of child-bearing potential
You will not qualify if you...
- Pregnant or breastfeeding 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
- Recent treatment with investigational drugs within 3 months or 5 half-lives
- Use of medications or supplements that strongly induce CYP3A4 enzyme
- Unresolved toxicities from prior therapy greater than grade 1 except alopecia or grade 2 neuropathy
- Severe or uncontrolled systemic diseases including active bleeding or uncontrolled hypertension
- Active infections including hepatitis B, C, or HIV
- History of drug-induced interstitial lung disease or radiation pneumonitis requiring steroids
- Hypersensitivity to osimertinib or similar drugs
- Conditions preventing swallowing of tablets or poor drug absorption
- Abnormal ECG with high risk for arrhythmias
- Investigator judgment that patient is unlikely to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (telemedicine or in-person) at start of osimertinib treatment
Duration - Approximately 9 weeks
Participants receive osimertinib 80mg orally daily for three 21-day cycles as standard care before randomization.
Visits at Cycle 1 Day 1 and Cycle 2 Day 1 to assess treatment and ctDNA status
Duration - Variable; chemotherapy given for 4 cycles (every 3 weeks) with ongoing osimertinib
Participants are randomized to continue osimertinib alone or receive osimertinib plus carboplatin and pemetrexed chemotherapy.
Multiple visits every 3 weeks for chemotherapy infusions and osimertinib monitoring; pill diary starts from Cycle 4
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
G
Gregory Riely, MD, PhD
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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