RecruitingPhase 2NCT05832827

First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)

First-line Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas

Sponsor

National Cancer Center, Japan

Enrollment

35 participants

Start Date

Sep 4, 2023

Study Type

INTERVENTIONAL

Conditions

Untreated Advanced or Recurrent Thymic Carcinomas

Summary

A phase II, investigator-initiated, non-randomized, open-label, single-arm, multicenter study to evaluate the efficacy and safety of Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab combination for previously untreated advanced or recurrent thymic carcinomas

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of four treatments — carboplatin (chemo), paclitaxel (chemo), lenvatinib (a targeted drug), and pembrolizumab (an immunotherapy drug) — as a first-line treatment for people with advanced or recurring thymic carcinoma, a rare cancer of the thymus gland in the chest. Researchers want to see how effective and safe this combination is. **You may be eligible if...** - You have been diagnosed with unresectable or metastatic thymic carcinoma (a rare type of chest cancer) - You have not yet received chemotherapy for this cancer - You do not have active brain metastases or spinal cord involvement requiring urgent treatment - You have not previously received anti-angiogenic drugs targeting VEGFR **You may NOT be eligible if...** - You have already received chemotherapy for this disease - Your cancer has spread to the brain or spinal cord in a way that requires immediate treatment - You recently received radiotherapy (within the past 14 days) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-3475

Pembrolizumab will be administered at a dose of 200 mg by intravenous infusion every 21 days (3 weeks) for up to 35 cycles.

DRUGLenvatinib

Lenvatinib will be administered at a dose of 8 mg orally QD every 21 days (3 weeks) for up to 4 cycles in the induction phase, followed by 20 mg QD for up to 31 cycles in the maintenance phase. Then, further maintenance therapy with lenvatinib will be allowed until progression or unacceptable adverse events.

DRUGCarboplatin

Carboplatin will be administered at a dose of AUC 5 intravenously every 21 days (3 weeks) for up to 4 cycles in the induction phase.

DRUGPaclitaxel

Paclitaxel will be administered at a dose of 175 mg/m\^2 intravenously every 21 days (3 weeks) for up to 4 cycles in the induction phase.

Locations(1)

National Cancer Center Hospital

Chūō, Tokyo, Japan

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NCT05832827