A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This study is a Phase III, international, multicenter, randomized, controlled, open-label clinical trial. The primary objective is to evaluate the efficacy and safety of furmonertinib plus platinum-based doublet chemotherapy (Arm A) versus osimertinib monotherapy (Arm B) in patients with EGFR sensitizing mutation-positive non-squamous non-small cell lung cancer (NSCLC) and brain metastases. Additionally, a proportion of subjects will receive furmonertinib monotherapy (Arm C) to further explore its efficacy and safety profile. Stage 1 is the safety run-in phase, planned to enroll approximately 30 subjects who will be randomized at a 1:1 ratio to receive either furmonertinib 80 mg QD plus platinum-based chemotherapy or furmonertinib 160 mg QD plus platinum-based chemotherapy, aiming to evaluate the safety and tolerability of different furmonertinib doses in combination with platinum-based chemotherapy. Stage 2 is the randomized controlled phase, in which approximately 350 subjects will be randomized in a 3:3:1 ratio (Arm A : Arm B : Arm C) to receive the investigational treatments.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat
- •Potwierdzony histologicznie lub cytologicznie rak płuca typu niedrobnokomórkowego bez komórek płaskonabłonkowych
- •Przerzuty raka do mózgu potwierdzone badaniem obrazowym
- •Mutacja EGFR w komórkach nowotworu (ex19del lub L858R)
- •Brak wcześniejszego leczenia systemowego (chemioterapia, terapia celowana) zaawansowanego raka płuca
- •Co najmniej jeden mierzalny guz w mózgu i co najmniej jeden poza mózgiem
- •Ogólny stan zdrowia pozwalający na leczenie (ECOG 0-1)
- •Prawidłowa funkcja szpiku kostnego i narządów wewnętrznych
✗ Disqualifies
- •Obecność komórek neuroendokrynnych, mięsaka lub raka płaskonabłonkowego stanowiącej więcej niż 10% nowotworu
- •Dodatkowe mutacje generujące oporność na leczenie
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 13, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Guangdong Provincial People's Hospital
Guangdong, China
Trial contact
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/14/2026.
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