Ivonescimab: ivonescimab iv at 20 mg/kg every 3 weeks
Carboplatin: For adenocarcinoma : Carboplatin area under the curve of 5 mg/mL/min (AUC 5) IV with pemetrexed 500 mg/m2 IV on day 1 every 21 days (Q3W) for 4 cycles
Pemetrexed: For adenocarcinoma : Carboplatin area under the curve of 5 mg/mL/min (AUC 5) IV with pemetrexed 500 mg/m2 IV on day 1 every 21 days (Q3W) for 4 cycles
Paclitaxel: For squamous cell carcinoma: Carboplatin AUC 6 mg/mL/min IV/ paclitaxel IV 200 mg/m2 on day 1 every 21 days (Q3W) for 4 cycles (or 175 mg/m2 on D1 for Asian participant) Q3W for 4 cycles
Paclitaxel-albumin: For squamous cell carcinoma: Carboplatin AUC 6 mg/mL/min IV/ albumin-bound paclitaxel 100 mg/m2 on D1, 8 and 15 Q3W for 4 cycles
Stereotactic Radiosurgery (SRS) or Fractionated Stereotactic Radiotherapy (FSRT): Patients will receive SRS/FSRT for all BM within ≤14 days from randomization, followed by 4 cycles of platinum-based chemotherapy combined with ivonescimab at 20 mg/kg every 3 weeks (Q3W). The systemic therapy should be initiated within 7 to 10 days after the end of SRS/FSRT but no earlier than 3 days after its completion. This will be followed by maintenance therapy with ivonescimab at 20 mg/kg plus pemetrexed (for patients with non-squamous NSCLC only) Q3W, for up to 2 years.
Study summary
This is a randomized, two-arm, comparative Phase II clinical trial designed to evaluate the difference in intracranial progression-free survival (iPFS) between two treatment strategies, assessed locally.
Approximately 158 patients will be randomized in a 1:1 ratio. Will be included patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment available and active asymptomatic brain metastasis (newly diagnosed or progressive).
The primary objective is to compare iPFS between the two arms.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age 18 years or older
* ECOG PS \<= 2
* Patients with pathology proven metastatic NSCLC without an actionable genomic alteration for which there is first line targeted treatment approved by EMA and recommended by the ESMO guidelines.
* Asymptomatic or clinically symptomatic brain metastases defined as requiring a dose of steroids of maximum 4 mg equivalent dexamethasone per day for the last 7 days to control neurological symptoms. With the clinically oligosymptomatic further defined as having no indication for immediate localized brain therapy, including neurosurgery or radiotherapy. Patients with controlled seizures can be enrolled.
* Newly diagnosed brain metastasis with the following characteristics:
* 1-10 newly diagnosed and untreated (except resected) brain metastases Note: if the neuronavigation MRI in the upfront SRS/FSRT arms shows \> 10 metastases, but the MRI used for enrolment showed 1-10 metastases, the patient will be still considered eligible.
* At least one metastasis should be at least 5x5 mm. In case of doubt on the diagnosis of brain metastasis, the lesion should not be irradiated but followed up.
* The largest metastasis must be \<10 mL in volume and \<30 mm in longest diameter (resected lesions would not count).
* The maximum cumulative volume of brain metastases must be \<30 mL (resected lesions would not count)
* Adequate Organ Function
Exclusion Criteria:
* Patients with oligometastatic NSCLC who are scheduled to receive radical local treatment to extra-cranial sites.
* Patients with contra-indications to brain MRI with gadolinium-based contrast agent.
* Active auto-immune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Patients with \>30 Gy of chest radiation therapy within 6 months prior to randomization; non-thoracic radiation therapy \>30Gy within 4 weeks prior to randomization, or palliative radiation therapy of ≤30 Gy within 7 days prior to randomization.
* Prior brain irradiation (including whole brain radiotherapy and SRS).
* Prior systemic treatment for metastatic NSCLC. Patients having received adjuvant or neoadjuvant chemotherapy or curative-intent chemoradiotherapy with or without PD-1/L1 inhibitors can be enrolled if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the development of metastatic disease.
* Major surgical procedures or serious trauma within 4 weeks prior to randomization or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to randomization.
* History of coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization
* Poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy
* History of serious cardiovascular, gastronintestinal, thromboembolic, neurological, or pulmonary conditions before randomization.
* History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization
Primary outcome measure(s)
Intracranial progression-free survival based on local assessment using RANO-BM criteria — First at week 6 and week 12 (±1 week) post-randomization. Then every 12 weeks (±2 weeks) until intracranial progression or study discontinuation. Time interval between the date of randomization and the date of intracranial progression or neurological related death, whichever occurs first
Trial sites (26)
Facility
City
Region
Status
Kepler University Hospital
Linz
Austria
Medical University of Vienna
Vienna
Austria
CLCC-Jean Perrin
Clermont-Ferrand
France
Centre Leon Berard
Lyon
France
Centre Antoine Lacassagne
Nice
France
Institut Godinot
Reims
France
Gustave Roussy
Villejuif
France
University Hospital Frankfurt -Senckenberg Institute of Neurooncology
Frankfurt am Main
Germany
Universitaetsklinikum Jena
Jena
Germany
Univ. Rostock-Zentrum für Radiologie mit Klinik und Poliklinik für Strahlentherapi
Rostock
Germany
General hospital of Athens 'Alexandra'
Athens
Greece
Diagnostic & Therapeutic Center of Athens Hygeia Hospital S.A.
Athens
Greece
Metropolitan Hospital
Athens
Greece
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia
Italy
RCCS Ospedale San Raffaele
Milan
Italy
Policlinico Universitario Campus Bio-Medico- Oncology Center
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.
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