Spanish Real World Data on Patients Treated With Durvalumab After Chemoradiotherapy. (S-REAL)

Fundación GECP

Status: Completed

Conditions: Small Cell Lung Cancer (SCLC)

Treatments: Drug: Durvalumab

Study type: Observational

Funder types: Other

Identifiers

NCT04285866

GECP 19/02_S-REAL

Details and patient eligibility

About

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.

Full 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:

To assess effectiveness of durvalumab in patients treated in real-life settings by evaluating 1-year survival rate, to describe adverse events of special interests, to stimate time and sites of disease progression or relapse in metastatic setting, to describe details on durvalumab treatment, to describe demographic and clinical characteristics of stage III unresectable NSCLC patients treated with Durvalumab, to describe previous chemoradiotherapy strategy, to describe the baseline staging status, to further assess subsequent treatments pattern at the time of disease progression including duration of therapy and type of therapy, and to explore healthcare resource utilization while on durvalumab treatment.

Enrollment: 245 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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).
2. Age ≥ 18 years at time of study Entry
3. Patients must have been treated with chemotherapy and radiotherapy concurrently or sequentially and shown no progressive disease following chemoradiation
4. Patients must have been enrolled in durvalumab EAPs between 1 September 2017 and 21 December 2018.
5. Patients must have been treated with at least one dose of durvalumab within the EAP
6. 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

1. Alive patients who do not want to sign and date an IRB/IEC-approved written informed consent form.
2. Patients who were accepted in the EAP, but did not receive treatment.
3. Patients treated with durvalumab in clinical studies prior to the index date (first dose of durvalumab received within the EAP

Trial design

245 participants in 1 patient group

Durvalumab Group

Description:

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.

Treatment:

Drug: Durvalumab