A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin: Randomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin
Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin: Randomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin
Study summary
The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — From date of first dose (Day 1) until date of progression at local site or death due to any cause or data cut-off date whichever occurred first (up to 3 years 1 month)
Progression free survival is defined as time from randomization until progression (intracranial or extracranial, whichever occurs first) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (for extracranial progression) and Central nervous system (CNS) RECIST 1.1 (for intracranial progression) as assessed by the Investigator at local site or death due to any cause.
Trial sites (40)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Silver Spring | Maryland | |
| Research Site | Boston | Massachusetts | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Ganzhou | China | |
| Research Site | Guangzhou | China | |
| Research Site | Jinan | China | |
| Research Site | Shenyang | China | |
| Research Site | Tianjin | China | |
| Research Site | Zhengzhou | China | |
| Research Site | Berlin | Germany | |
| Research Site | Cologne | Germany | |
| Research Site | Cologne | Germany | |
| Research Site | Hanover | Germany | |
| Research Site | München | Germany | |
| Research Site | Beersheba | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Jerusalem | Israel | |
| Research Site | Kfar Saba | Israel | |
| Research Site | Tel Aviv | Israel | |
| Research Site | Tel HaShomer | Israel | |
| Research Site | Florence | Italy | |
| Research Site | Meldola | Italy | |
| Research Site | Messina | Italy | |
| Research Site | Naples | Italy | |
| Research Site | Padova | Italy | |
| Research Site | Roma | Italy | |
| Research Site | Terni | Italy | |
| Research Site | Verona | Italy | |
| Research Site | Alicante | Spain | |
| Research Site | Barcelona | Spain | |
| Research Site | Córdoba | Spain | |
| Research Site | León | Spain | |
| Research Site | Madrid | Spain | |
| Research Site | Málaga | Spain | |
| Research Site | Murcia | Spain | |
| Research Site | Oviedo | Spain | |
| Research Site | Palma de Mallorca | Spain | |
| Research Site | Seville | Spain | |
| Research Site | Valencia | Spain |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04765059 on ClinicalTrials.gov ↗ ← All trials in the USA