Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC
Protocol 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)
Sponsor: Swiss Cancer Institute
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective response rate (ORR) according to RECIST v1.1
Time frame: At the end of trial treatment, up to 2 years from registration.
Secondary Endpoints
Duration of response (DoR) according to RECIST v1.1
Progression-free Survival (PFS) according to RECIST v1.1
Eligibility Criteria
Inclusion Criteria: * Patients fulfilling all of the following inclusion criteria are eligible for the trial: * Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures including patient screening. * Confirmed squamous or non-squamous mNSCLC stage IIIB-IV (based on 9th edition Tumor-Node-Metastasis (TNM) classification of lung cancers with disease recurrence or progression during or after one or more prior immunotherapy or CIT regimens for metastatic disease. * Patients with treated and stable central nervous system (CNS) metastases are eligible, if: * Previous CNS-directed therapy has been completed at least 4 weeks prior to treatment start. * No evidence of progression after completion of CNS-directed therapy as ascertained by clinical examination and brain imaging with Magnetic Resonance Imaging (MRI) or CT.25 * Patients with known HIV-infection are eligible, if: * CD4+ T-cell counts are ≥ 350 …
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Expert commentary on why this trial matters and what to watch for.
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