Overview
Sponsor-declared trial summary
Stage III non-small cell lung cancer
-to assess the safety of surgery in patients with initially unresectable stage III NSCLC who are considered resectable by the multidisciplinary team within 12 weeks after finishing high-dose CRT -to assess the ability to proceed to durvalumab consolidation therapy after surgery
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 16 Dec 2024 → ongoing
- Decision date (initial)
- 2024-06-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
-to assess the safety of surgery in patients with initially unresectable stage III NSCLC who are considered resectable by the multidisciplinary team within 12 weeks after finishing high-dose CRT
-to assess the ability to proceed to durvalumab consolidation therapy after surgery
Secondary objectives 2
- to assess the rate of complete surgical resection (R0)
- To assess disease free survival (DFS) at 2 years
Conditions and MedDRA coding
Stage III non-small cell lung cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Histologically or cytologically confirmed stage III (non-N3) NSCLC (TNM 8th edition), before start of chemoradiotherapy
- In case of suspected N2-disease, mediastinal invasive staging (EUS, EBUS and/or mediastinoscopy) to prove N2 involvement before start of concurrent CRT is mandatory.
- Initial MDT recommendation for a non-surgical treatment comprising CRT followed by durvalumab
Exclusion criteria 4
- Patients with TxN3 or M1 disease
- The use of any CRT schemes other than those in ESMO recommendations (platinum doublet, 30 once-daily fractions of 2 Gy)
- Patients deemed inoperable based on cardiopulmonary function tests or comorbidity
- Patients with known actionable genomic alterations.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Safety defined as the rates of severe surgical morbidity and mortality (Clavien-Dindo grade 3-5) and the percentage of patients with treatment-related adverse events (Gr III-V) within 90-days of surgery
- Number of patients able to proceed to durvalumab consolidation after surgery
Secondary endpoints 2
- Rate of complete surgical resection (R0)
- DFS in 2 years, defined from the day of surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
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
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XC28 — -
- 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Chris Dickhoff
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Chris Dickhoff
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 38 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-12-16 | 2024-12-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_CROWD Clinical Trial Protocol_2024-511711-21-00 | 5 |
| Protocol (for publication) | D1_CROWD Clinical Trial Protocol_2024-511711-21-00_TC | 5 |
| Recruitment arrangements (for publication) | K1_recruitment procedure NL_CROWD | 2 |
| Recruitment arrangements (for publication) | K1_recruitment procedure NL_CROWD_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_participants_CROWD | 5 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_participants_CROWD_TC | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_durvalumab | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Dutch | 5 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Dutch_TC | 5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-15 | Netherlands | Acceptable with conditions 2024-06-07
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-06 | Netherlands | Acceptable 2024-12-11
|
2024-12-12 |