OncoMatch/Clinical Trials/NCT04410796
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Is NCT04410796 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Osimertinib and Carboplatin for metastatic non-small cell lung cancer.
Treatment: Osimertinib · Carboplatin · Pemetrexed — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR
Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA
Required: EGFR
Patients with detectable plasma EGFR mutations at C2D1
Disease stage
Required: Stage IV
Metastatic disease required
metastatic non-small cell lung cancer; measurable (RECIST 1.1) indicator lesion not previously irradiated
Prior therapy
Cannot have received: chemotherapy
Exception: adjuvant therapy > 6 months prior to study start is acceptable
no prior chemotherapy for treatment of metastatic disease (adjuvant therapy > 6 months prior to study start is acceptable)
Lab requirements
Blood counts
Hemoglobin ≥ 9 g/dL; Platelets ≥ 150,000mm^3 (initial) or ≥ 100,000mm^3 (randomization); Absolute neutrophil count (ANC) ≥ 1500 cells/mm^3
Kidney function
Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault equation
Liver function
AST, ALT ≤ 2.5 x ULN with no liver metastases or < 5x ULN with the presence of liver metastases (initial); AST, ALT ≤ 3x ULN with no liver metastases or ≤ 5x ULN with the presence of liver metastases (randomization); Total bilirubin ≤ 1.5 x ULN if no liver metastases or < 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases
Cardiac function
Mean resting corrected QT interval (QTc) > 470 msec (QTcF) excluded; clinically important ECG abnormalities excluded; factors increasing risk of QTc prolongation or arrhythmic events excluded
Adequate organ function (see detailed criteria); cardiac criteria: QTc > 470 msec, ECG abnormalities, risk factors for QTc prolongation/arrhythmia excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UC Davis Cancer Center (Data Collection Only) · Sacramento, California
- University of California San Francisco · San Francisco, California
- Moffitt Cancer Center · Tampa, Florida
- John Hopkins Medical Center · Baltimore, Maryland
- Massachusetts General Hospital (Data Collection Only) · Boston, Massachusetts
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04410796 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required (metastatic disease required).
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify