Status:
RECRUITING
NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
North-Eastern German Society of Gynecological Oncology (NOGGO e.V.)
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-130 years
Brief Summary
This is a German multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and patient-reported outcome (PRO) data in patients with primary advanced (FIGO stage III or I...
Detailed Description
This is a multi-center, prospective, non-interventional study (NIS) to collect real-world clinical and PRO data in patients with primary advanced (FIGO stage III or IV) or recurrent EC receiving 1L CP...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06890273
Start Date
May 20 2025
End Date
September 30 2028
Last Update
December 16 2025
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Berlin, Germany
2
Research Site
Bielefeld, Germany
3
Research Site
Borna, Germany
4
Research Site
Bottrop, Germany