A Phase II, open label, single arm, multicentre study on THOracic Radiotherapy in Extensive Stage SCLC patients submitted to first line CHT-RT plus Durvalumab (MEDI4736)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Azienda Ospedaliero Universitaria Di Modena

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

completed 27 Jan 2025

Decision date (initial)

2024-11-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AstraZeneca S.p.A.

External identifiers

EU CT number

2024-517445-13-00

EudraCT number

2021-006578-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To assess the efficacy of first line chemo-immunotherapy with cisplatin/carboplatin, etoposide plus durvalumab followed by consolidation durvalumab monotherapy and concomitant thoracic radiation therapy by assessment of 12-Months progression-free survival (PFS, defined as time from enrollment to the date of objective disease progression both locoregionally and/or systemically) or death for any cause in the absence of progression of disease) in extensive stage SCLC patients.

Secondary objectives 1

1. •To evaluate the long-term clinical outcomes of : -overall survival and metastasis free survival of chemo-immunotherapy followed by consolidation durvalumab monotherapy plus consolidation thoracic radiation therapy -loco- regional control of chemo-immunotherapy followed by consolidation durvalumab monotherapy plus consolidation thoracic radiation therapy -lung cancer mortality of chemo-immunotherapy followed by consolidation durvalumab monotherapy plus consolidation thoracic radiation therapy •To further assess the efficacy of chemo-immunotherapy followed by consolidation durvalumab monotherapy plus consolidation thoracic radiation therapy in terms of ORR according to RECIST 1.1 as assessed by the Investigator •To assess the safety and tolerability profile of chemo-immunotherapy followed by consolidation durvalumab monotherapy plus consolidation thoracic radiation therapy vs chemo-immunotherapy alone

Conditions and MedDRA coding

Extended stage small cell lung cancer patients confirmed histologically in full, partial or stable response after platinum-etoposide chemo-immunotherapy candidate to maintenance immunotherapy with Durvalumab.

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Large-stage small cell lung cancer confirmed by histology • Imaging at diagnosis: chest/abdominal CT + bone scan (or 18 FDG PET CT) + brain MRI, • CR, PR, or SD after first-line platinum-based chemotherapy plus Durvalumab for up to 4 cycles • Candidate for maintenance immunotherapy with Durvalumab • ECOG Performance Status 0-2 • Normal lung functions • Planning target volume < 600 cc • Body weight >30 kg • Able to sign informed consent • Age >18 years but < 80 years • No previous thoracic radiotherapy • Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use a highly effective method of contraception during the study.

Exclusion criteria 1

1. • Histology of non-small cell lung cancer • Limited-stage SCLC • Previous immunotherapy of any type • Contraindication for immunotherapy (active or previous autoimmune or inflammatory disorders) • Primary immunodeficiency • Acute/chronic respiratory failure • Presence of symptomatic or progressive brain metastases • Other contraindications that do not allow radiotherapy (inflammatory interstitial lung disease, etc.)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The assessment of 12-Months progression-free survival (PFS, defined as time from enrollment to the date of objective disease progression both locoregionally and/or systemically) or death for any cause in absence of progression of disease) in extensive stage SCLC patients

Secondary endpoints 1

1. Overall survival, Loco-regional control, Metastasis-free survival, Overall response rate, Acute toxicity, Late toxicity, General security profile, Quality of life

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Azienda Ospedaliero Universitaria Di Modena

Sponsor organisation

Azienda Ospedaliero Universitaria Di Modena

Address

Largo Del Pozzo 71

City

Modena

Postcode

41124

Country

Italy

Scientific contact point

Organisation

Azienda Ospedaliero Universitaria Di Modena

Contact name

Alessio Bruni

Public contact point

Organisation

Azienda Ospedaliero Universitaria Di Modena

Contact name

Alessio Bruni

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications