OncoMatch/Clinical Trials/NCT04410796
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
Is NCT04410796 recruiting? Yes, currently enrolling (May 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
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 →
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