NCT03775486CompletedPhase 2
A Phase II trial find out the effectiveness and safety of durvalumab combined with olaparib compared to durvalumab alone, in treating patients with metastatic non-small cell lung cancer who have not had worsening of their cancer after treatment with durvalumab and chemotherapy.
A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab plus Olaparib Combination Therapy Compared with Durvalumab Monotherapy as Maintenance Therapy in Patients whose Disease has not Progressed Following Standard of Care Platinum-Based Chemotherapy with Durvalumab in First Line Stage IV NonSmall Cell Lung Cancer (ORION)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 7 Oct 2024
Brief summary (registry, in English)
To assess the efficacy of durvalumab plus olaparib combination therapy compared with durvalumab monotherapy in terms of PFS (Investigator-assessed).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 27 Aug 2024
- Start date
- 14 Nov 2018
- Lead sponsor
- AstraZeneca AB
- Diseases
- Lung cancer
- NCT number
- NCT03775486
- EU CT number
- 2024-512769-16-00
- EudraCT number
- 2018-003460-30
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), PARP therapy, or immune-mediated therapy
- Active or prior documented autoimmune or inflammatory disorders
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of IP
Other illness
- Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology
- Active infection
Other
- untreated (CNS) metastases and/or carcinomatous meningitis
Who the study is looking for
- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation (according to version 8 of the IASLC Staging Manual in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology 2016)
- Patients must have tumors that lack activating EGFR mutations and ALK fusions.
- (WHO)/(ECOG)performance status of 0 or 1
- No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
- Adequate organ and marrow function without blood transfusions in the past 28 days
- At least 1 tumor lesion, not previously irradiated, that can be accurately measured as perRECIST 1.1. Key Inclusion criteria for randomization to maintenance treatment
- Documented radiographic evidence of CR, PR, or SD as per Investigator-assessed RECIST1.1 following 4 cycles of platinum-based chemotherapy.
- CrCl ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection.
- Ability to swallow whole oral medications. Patients not having GI illnesses Please refer to the protocol for rest of inclusion criteria
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instytut MSF Sp. z o.o. Coordinator of this site? Confirm its status | Lodz | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.