OncoMatch/Clinical Trials/NCT04335292
Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer with Osimertinib Third-line Rechallenge
Is NCT04335292 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Osimertinib First-Line and Platinum + Pemetrexed Chemotherapy Second-Line for non-small cell lung cancer.
Treatment: Osimertinib First-Line · Platinum + Pemetrexed Chemotherapy Second-Line · Osimertinib Third-Line — This phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy. The repeat of osimertinib following previous treatment failure is investigational, although supported by scientific rationale. The dosing and scheduling of osimertinib follows its use in approved settings. The investigators examine its tolerability and efficacy in this setting to ensure osimertinib is a safe third-line option for patients with Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer(aNSCLC).
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR activating mutation
Patients must have a known activating Epidermal Growth Factor Receptor (EGFR) mutation. Atypical Epidermal Growth Factor Receptor (EGRF) mutations are allowed. Atypical mutations may require sponsor approval. Exon 20 insertions will not be allowed.
Performance status
ECOG/WHO 0–3
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, cisplatin) — second-line
Patients must have received platinum/ pemetrexed chemotherapy in the second-line chemotherapy
Must have received: pemetrexed (pemetrexed) — second-line
Patients must have received platinum/ pemetrexed chemotherapy in the second-line chemotherapy
Cannot have received: adjuvant cytotoxic chemotherapy
Previous adjuvant cytotoxic chemotherapy within the 6 months prior to enrollment.
Cannot have received: anti-PD-1 therapy
Previous adjuvant anti programmed cell death protein 1(anti-PD-1) or anti programmed death-ligand 1 (anti-PD-L1) therapy within 90 days prior to enrollment.
Cannot have received: anti-PD-L1 therapy
Previous adjuvant anti programmed cell death protein 1(anti-PD-1) or anti programmed death-ligand 1 (anti-PD-L1) therapy within 90 days prior to enrollment.
Cannot have received: systemic therapy for EGFR+ advanced NSCLC
Any previous systemic therapy for Epidermal Growth Factor Receptor mutated (EGFR+) advanced Non-Small Cell Lung Cancer (aNSCLC).
Lab requirements
Blood counts
absolute neutrophil count less than1.5 x 10^9/L, platelet count less than 100 x 10^9/L, haemoglobin less than 90 g/L
Kidney function
serum creatinine greater than 1.5 times ULN concurrent with creatinine clearance less than 50 mL/min [measured or calculated by Cockcroft and Gault equation]-confirmation of creatinine clearance is only required when creatinine is greater than 1.5 times ULN.
Liver function
alanine aminotransferase greater than 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases; aspartate aminotransferase greater than 2.5 times ULN if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases; total bilirubin greater than 1.5 times ULN if no liver metastases or greater than 3 times ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinaemia] or liver metastases
Cardiac function
Mean resting corrected QT interval (QTc) greater than 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value; Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG; Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities [including serum/plasma potassium less than the Lower Limit of Normal (LLN), serum/plasma magnesium greater than the Lower Limit of Normal (LLN), serum/plasma calcium less than the Lower Limit of Normal (LLN)], congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
Inadequate bone marrow reserve or organ function (as demonstrated by any of the following laboratory values: absolute neutrophil count less than1.5 x 10 to the power of 9/L, platelet count less than 100 x 10 to the power of 9/L, haemoglobin less than 90 g/L), alanine aminotransferase greater than 2.5 times upper limit of normal (ULN) if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases; aspartate aminotransferase greater than 2.5 times ULN if no demonstrable liver metastases or greater than 5 times ULN in the presence of liver metastases; total bilirubin greater than 1.5 times ULN if no liver metastases or greater than 3 times ULN in the presence of documented Gilbert's Syndrome [unconjugated hyperbilirubinaemia] or liver metastases; serum creatinine greater than 1.5 times ULN concurrent with creatinine clearance less than 50 mL/min [measured or calculated by Cockcroft and Gault equation]-confirmation of creatinine clearance is only required when creatinine is greater than 1.5 times ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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