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Phase II Study of Upfront SRT Plus Ivonescimab/Chemotherapy vs Ivonescimab/Chemotherapy in NSCLC Brain Mets

NCT07234877 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2026-06-04

No results posted yet for this 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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

DRUG

Ivonescimab

ivonescimab iv at 20 mg/kg every 3 weeks

DRUG

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

DRUG

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

DRUG

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

DRUG

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

RADIATION

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.

Sponsors & Collaborators

  • Summit Therapeutics

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Lizza Hendriks, MD, PhD · Maastricht UMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2032-01-31
Completion
2032-04-30

Countries

  • Austria
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Slovenia
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234877 on ClinicalTrials.gov