Spanish Real World Data on Unresectable Stage III NSCLC Patients Treated With Durvalumab After Chemoradiotherapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 245
- Locations
- 39
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
Brief Summary
This is a non-interventional, observational, multicentre, one-arm, non-comparative, and retrospective study.
The study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival.
Detailed Description
Lung Cancer represent approximately 13% of total cancer diagnoses worldwide and continues to be the leading cause of cancer-related mortality. Stage III represents between 25-30% of NSCLC and the majority of them are unresectable. The standard treatment in unresectable patients was chemoradiotherapy consurrently if possible.
The PACIFIC study is a phase III study to evaluate the efficacy and safety of durvalumab as a sequential therapy concurrent platinum-based chemotherapy and thoracic RT. The study was positive for both primary endpoints progression-free survival and overall survival. After that, it was decided to open an early acces programme ti provide acces to durvalumab for patients with locally advanced, unresectable NSCLC (stage III) tho have not progressed following chemoradiation.
This observational study is based on the collection of data about the patients treated with Durvalumab after chemoraditherapy in the real world.
The study will include all patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.
The primary objective is to assess affectiveness of durvalumab in patients treated in real-life settings by evaluating Progression Free Survival. Other secondary objectives are:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent, unresectable (stage III) disease (according to American Joint Committee on Cancer [AJCC] lung cancer edition 7 or 8).
- •Age ≥ 18 years at time of study Entry
- •Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
- •Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December
- •Patients must have been treated with at least one dose of durvalumab within the EAP
- •Alive patients must have signed, dated and IRB/EC-approved written informed consent* form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.
Exclusion Criteria
- •Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
- •Patients who were accepted in the EAP, but did not receive treatment.
- •Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP
Arms & Interventions
Durvalumab Group
Patients who have participated in the EAP between 1 September 2017 up to 21 December 2018 and have received at least 1 dose of durvalumab.
Intervention: Durvalumab (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months
To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating PFS
Secondary Outcomes
- 1-year survival rate(1 year)
- Time and site of disease progression or relapse(From date of the first dose of durvalumab received to the date of disease progression, assessed up to 60 months)
- To describe adverse events of special interest (AESIs)(From date of the first dose of durvalumab received (within the EAP) to the date of disease progression, death, or the end of follow-up, assessed up to 60 months)