Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
43
Countries
1
Sites
10
extensive stage small cell lung cancer (SCLC)
1. To prove feasibility of a treatment scheme consisting of thoracic radiotherapy concomitant to platinum/etoposide/durvalumab therapy followed by stereotactic radiotherapy concomitant to durvalumab maintenance. 2. To study the efficacy of this treatment scheme to improve the PFS rate at 12 months.
Key facts
- Sponsor
- Universitaet Des Saarlandes
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517937-41-00
- EudraCT number
- 2022-001822-31
- ClinicalTrials.gov
- NCT06223711
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
1. To prove feasibility of a treatment scheme consisting of thoracic radiotherapy concomitant to platinum/etoposide/durvalumab therapy followed by stereotactic radiotherapy concomitant to durvalumab maintenance.
2. To study the efficacy of this treatment scheme to improve the PFS rate at 12 months.
Conditions and MedDRA coding
extensive stage small cell lung cancer (SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
| 27.0 | PT | 10059514 | Small cell lung cancer metastatic | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 1. Histologically confirmed first diagnosis of ES-SCLC according to the Veterans Administration Lung Study Group (VALG) Staging System for SCLC.
- Oligometastatic disease defined as follows: Primary tumor with or without mediastinal or supraclavicular lymph node metastases. Up to four distant tumor lesions/metastases that can be treated with stereotactic radiotherapy. No cytologically confirmed malignant pleural effusion.
- Stable disease (SD) or partial response (PR) according to RECIST 1.1 criteria after previous treatment with two cycles of platinum/etoposide/durvalumab.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Must have a life expectancy of at least 12 weeks.
Exclusion criteria 7
- Prior systemic anticancer therapy (chemotherapy, immunotherapy, targeted therapy), apart from two cycles of etoposide/platinum + durvalumab
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous chemo-immunotherapy
- Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
- Major surgical procedure within 28 days prior to the first dose of IP.
- Active or prior documented autoimmune or inflammatory disorders
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- One-year progression-free survival (PFS) rate using investigator assessments according to RECIST 1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Cisplatin NeoCorp 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
PRD759858 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 150 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 39021.01.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 19500 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carbomedac 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD11563618 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVASCULAR USE
- Max daily dose
- 5 Other
- Max total dose
- 10 Other
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 39079.02.00
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Eto-GRY® 20 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD3108091 · Product
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 540 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- 45891.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaet Des Saarlandes
- Sponsor organisation
- Universitaet Des Saarlandes
- Address
- Kirrberger Strasse 100
- City
- Homburg
- Postcode
- 66421
- Country
- Germany
Scientific contact point
- Organisation
- Universitaet Des Saarlandes
- Contact name
- Prof. Dr. Markus Hecht
Public contact point
- Organisation
- Universitaet Des Saarlandes
- Contact name
- Prof. Dr. Markus Hecht
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Interdisziplinaeres Zentrum Klinische Studien (IZKS) ORG-100029409
|
Mainz, Germany | Code 8 |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruitment pending | 43 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaet Des Saarlandes
Klinik für Strahlentherapie und Radioonkologie, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Augsburg
Klinik für Strahlentherapie, Stenglinstrasse 2, Kriegshaber, Augsburg
Kliniken Maria Hilf GmbH Moenchengladbach
Klinik für Strahlentherapie, Viersener Strasse 450, Windberg, Moenchengladbach
Universitaetsklinikum Erlangen AöR
Strahlenklinik, Universitaetsstrasse 27, Innenstadt, Erlangen
Johannes Gutenberg University Mainz
Klinik und Poliklinik für Radioonkologie und Strahlentherapie, Langenbeckstrasse 1, 55101, Mainz
Universitaetsklinikum Regensburg AöR
Klinik und Poliklinik für Strahlentherapie, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Giessen und Marburg GmbH
Klinik für Strahlentherapie, Klinikstrasse 33, 35392, Giessen
Julius-Maximilians-Universitaet Wuerzburg
Klinik und Poliklinik für Strahlentherapie, Josef-Schneider-Strasse 11, Grombuehl, Wuerzburg
Rostock University Medical Center
Klinik und Poliklinik für Strahlentherapie, Nr. 05, Suedring 75, Rostock
Krankenhaus Nordwest GmbH
Klinik für Radioonkologie, Steinbacher Hohl 2-26, Praunheim, Frankfurt Am Main
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_DuCoRa-SCLC_Protocol_2024-517937-41-00_redacted | 1.4 |
| Recruitment arrangements (for publication) | DuCoRa-SCLC_CTIS_placeholder_doc_for_transitional_trials | 1 |
| Subject information and informed consent form (for publication) | L1_DuCoRa-SCLC_SIS_ICF_redacted | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin_Jun2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cisplatin_Jun2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etoposid_Dez2023 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_IMFINZI_Jun2024 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Germany | Acceptable 2024-10-25
|
2024-10-29 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-06 | Germany | Acceptable 2024-10-25
|
2025-10-06 |