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Clinical Trials in the EU / 2026-526043-36-00
Authorised, not yet recruiting Phase II

SAKK 18/25: Overcoming Resistance to Immunotherapy combining Gemcitabine with Ivonescimab in advanced NSCLC progressing on immune checkpoint inhibitors: A multicenter, single-arm, open-label phase II trial (ORIGIN2)

2026-526043-36-00 · tracked via the Priya Life Science EU tracker
Sponsor
Swiss Cancer Institute, Cancer Trials Ireland
Sponsor type
Patient organisation/association, Patient organisation/association
Therapeutic area
Neoplasms
Decision date
30/10/2026
Enrollment target
12
Sites
Ireland

Condition studied

advanced NSCLC

Investigational medicinal product(s)

ivonescimabGemcitabine 100 mg/ml Concentrate for Solution for Infusion

Every trial of Ivonescimab and Gemcitabine across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.4 The primary analysis will be based on the results from the independent response review.

Endpoint detail

Duration of response (DoR) according to RECIST v1.1, Progression-free survival (PFS) according to RECIST v1.1., ORR according to iRECIST (iORR)., DoR according to iRECIST (iDoR)., PFS according to iRECIST (iPFS)., Overall survival (OS)., Adverse events (AEs) are graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-526043-36-00 on CTIS ↗ ← All trials in the EU