First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent… (NCT05832827) | Clinical Trial Compass
RecruitingPhase 2
First-line CBDCA/PTX/LEN/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas (Artemis)
Japan35 participantsStarted 2023-09-04
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients aged 18 years or older at the time of informed consent, who are pathologically (histologically or cytologically) diagnosed with thymic carcinoma for primary or metastatic thymic lesions, are included. They are preferred to be positive for CD5 or c-KIT by immunohistochemical staining. For those with non-squamous epithelial carcinoma negative for p40 or p63, non-primary cases should be excluded based on their clinical and pathological findings. In addition, those with thymoma are excluded.
✓. Patients with unresectable advanced thymic carcinoma (equivalent to stage IVa or IVb of Masaoka-Koga classification), metastatic or recurrent, who have not been treated with systemic cancer chemotherapy.
✓. No symptomatic brain metastases, carcinomatous meningitis, or spinal metastases requiring radiotherapy or surgery
✓. No prior history of an antiangiogenetic agent targeting VEGFR for thymic carcinoma
✓. Not receiving radiotherapy within 14 days before registration Male participants
✓. A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 135 days after the last dose of study treatment and refrain from donating sperm during this period.
✓. A female participant is eligible to participate if she is not pregnant (see Appendix 3), not breastfeeding, and at least one of the following conditions applies:
✓. Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 OR
Exclusion criteria
✕
What they're measuring
1
Response Rate (RR) by the Blinded independent review committee
✕. Has related immune-related complications such as myasthenia gravis, pure red cell aplasia, or hypogammaglobulinemia
✕. Patients with ECG QT correction interval prolongation or history of such prolongation (patients with QTcF \> 480 ms)
✕. Has a LVEF below the institutional normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO)
✕. A WOCBP who has a positive urine pregnancy test within 72 hours prior to registration (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
✕. Has urine protein ≥1 g/24 hours Note: Participants with proteinuria ≥2+ (≥100 mg/dL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria
✕. Has had major surgery within 3 weeks prior to the first dose of study interventions
✕. Has clinically significant cardiovascular disease within 12 months from the first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability