NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)

Launched by ASTRAZENECA · Mar 17, 2025

Keywords

ClinConnect Summary

The DUOLife clinical trial is looking at how effective and safe a combination of two medications, Durvalumab and Olaparib, are for women with advanced or recurrent endometrial cancer (a type of cancer that starts in the lining of the uterus). This study is being conducted in Germany and aims to gather real-life information about how these treatments work for patients who are receiving them as part of their first line of therapy. Participants will be women aged 18 and older who have been diagnosed with advanced stage endometrial cancer or recurrent disease that cannot be cured and are starting treatment with a specific combination of chemotherapy and these medications.

To join the trial, women must meet certain criteria, such as having a confirmed diagnosis of endometrial cancer and being able to complete patient-reported questionnaires in languages like German or English. Participants can expect to receive standard treatment and will be asked to share their experiences and health information throughout the study. It’s important to note that the trial is not yet recruiting participants, and women who are pregnant, breastfeeding, or have certain medical conditions may not be eligible. This trial will help researchers understand how these medications perform in the real world, which can lead to better care for future patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged ≥ 18 years at the time of screening.
• * Patient has pathologically documented:
• • Primary advanced (FIGO III and IV) epithelial EC OR
• • Recurrent disease that is unlikely to be cured and where the multidisciplinary tumor board decision is systemic therapy. Carcinosarcomas are allowed,
• • Patient is intended or initiated to receive 1L CPD followed by maintenance therapy with durvalumab (dMMR cohort) or with durvalumab and olaparib (pMMR cohort) according to the SmPC of IMFINZI® and Lynparza®\* prior to enrollment. Recruitment of patients that already started and may have received up to 2 cycles of CPD is allowed but will be capped to 25% of the study population.
• • Patient is eligible for treatment with durvalumab and/or olaparib as specified in the IMFINZI® and Lynparza® SmPC. The prescription of the medicinal product is clearly separated from the decision to include the patient in the study.
• • MMR-testing results of the patient's tumor are known.
• • Patient is willing and able to complete PRO questionnaires.
• • Patient can read and understand German, English, Arab, Russian or Turkish.
• • Signed written informed consent.
• Exclusion Criteria:
• • Patient has already received ≥2 cycles of 1L CPD
• • Known hypersensitivity to carboplatin, paclitaxel, durvalumab and/or olaparib or any of the excipients of the drug.
• • Pregnancy or breast-feeding.
• • Unable to swallow orally administered medication.
• • Current or planned participation in an interventional clinical trial.
• • Current or planned systemic treatment of any tumor other than primary advanced or recurrent EC.
• • Patient has pathologically documented sarcoma