A Study of Osimertinib With or Without Chemotherapy Versus Chemotherapy Alone as Neoadjuvant Therapy for Patients With EGFRm Positive Resectable Non-Small Cell Lung Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Osimertinib: Oral
Cisplatin: Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
Carboplatin: Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
Placebo: Oral
Pemetrexed: Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
Study summary
This is a Phase III, randomised, controlled, 3-arm, multi-centre study of neoadjuvant osimertinib as monotherapy or in combination with chemotherapy, versus SoC chemotherapy alone, for the treatment of patients with resectable EGFRm Non-Small Cell Lung Cancer
Eligibility
Primary outcome measure(s)
- Major Pathological Response (MPR) - IASLC Method — From date of randomization to an average of 12 weeks after the first dose
Defined as ≤10% viable cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery (IASLC method). Patients will only be considered to have an MPR if they also have an R0 margin result. - Major Pathological Response (MPR) - Chemotherapy Method — From date of randomization to an average of 12 weeks after the first dose
Defined as ≤10% viable cancer cells in the surgical specimen, as assessed per central pathology laboratory post-surgery (chemotherapy method). Patients will only be considered to have an MPR if they also have an R0 margin result.
Trial sites (158)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Duarte | California | |
| Research Site | Irvine | California | |
| Research Site | San Francisco | California | |
| Research Site | Santa Monica | California | |
| Research Site | Santa Rosa | California | |
| Research Site | Boston | Massachusetts | |
| Research Site | Lebanon | New Hampshire | |
| Research Site | Commack | New York | |
| Research Site | New York | New York | |
| Research Site | Houston | Texas | |
| Research Site | Fairfax | Virginia | |
| Research Site | Seattle | Washington | |
| Research Site | Graz | Austria | |
| Research Site | Vienna | Austria | |
| Research Site | Barretos | Brazil | |
| Research Site | Fortaleza | Brazil | |
| Research Site | Jaú | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Porto Alegre | Brazil | |
| Research Site | Recife | Brazil | |
| Research Site | Rio de Janeiro | Brazil | |
| Research Site | Santa Maria | Brazil | |
| Research Site | São José do Rio Preto | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | São Paulo | Brazil | |
| Research Site | Panagyurishte | Bulgaria | |
| Research Site | Pleven | Bulgaria | |
| Research Site | Sofia | Bulgaria | |
| Research Site | Toronto | Ontario | |
| Research Site | Montreal | Quebec | |
| Research Site | Las Condes | Chile | |
| Research Site | Santiago | Chile | |
| Research Site | Santiago | Chile | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Beijing | China | |
| Research Site | Changsha | China | |
| Research Site | Changsha | China | |
| Research Site | Chengdu | China |
+ 118 more sites — see the full list on the official registry below.
On this site
📄 Tagrisso (osimertinib) drug profile →More AstraZeneca trials in Turkey
Other trials for the same condition
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 NCT04351555 on ClinicalTrials.gov ↗ ← All trials in Turkey