WCLC 2025 - Posters & ePosters-P3.18.83 Efficacy and Safety of Ivonescimab Plus Chemotherapy for Recurrent/Metastatic Thymic Carcinoma: A Phase II Study (iThyme)

P3.18.83 Efficacy and Safety of Ivonescimab Plus Chemotherapy for Recurrent/Metastatic Thymic Carcinoma: A Phase II Study (iThyme)

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This phase II, single-arm, Simon’s two-stage study (NCT06750952) conducted at Sun Yat-sen University Cancer Center evaluates the efficacy and safety of ivonescimab combined with chemotherapy in patients with recurrent or metastatic thymic cancer (TC). TC is a rare malignancy with limited treatment options, especially in advanced stages where platinum-based chemotherapy yields a modest ~30% response rate. Ivonescimab is a novel bispecific antibody targeting PD-1 and VEGF, previously showing promise in non-small cell lung cancer by simultaneously inhibiting immune checkpoints and angiogenesis.<br /><br />Eligible patients are adults with histologically confirmed, untreated, unresectable thymic cancer, ECOG performance status 0-1, measurable disease per iRECIST, and adequate organ function. The treatment regimen consists of induction therapy with ivonescimab (20 mg/kg, every 3 weeks) plus paclitaxel (175 mg/m²) or albumin-bound paclitaxel (260 mg/m²) and carboplatin (AUC5) for 4-6 cycles, followed by maintenance ivonescimab until disease progression or unacceptable toxicity.<br /><br />The primary endpoint is the 6-month progression-free survival rate (PFS6m). Secondary endpoints include progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. Biomarker analyses on tumor tissue and blood samples are exploratory.<br /><br />Using Simon’s optimal design, 8 patients are enrolled in Stage I; if fewer than 3 progressions occur by 6 months, Stage II will enroll an additional 16 patients (total 24). Success is defined as fewer than or equal to 10 progressions at 6 months in the full cohort. Patient enrollment is ongoing.<br /><br />This study seeks to establish whether ivonescimab plus chemotherapy can improve outcomes in this difficult-to-treat population by leveraging dual targeting of immune checkpoints and angiogenesis, potentially offering a new first-line treatment option for recurrent/metastatic thymic cancer.

Asset Subtitle

Xue Hou

Meta Tag

Speaker Xue Hou

Topic Clinical Trials in Progress

Keywords

ivonescimab

thymic cancer

phase II clinical trial

Simon’s two-stage design

PD-1 inhibitor

VEGF inhibitor

chemotherapy

progression-free survival

immune checkpoint blockade

angiogenesis inhibition