Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
500
Countries
1
Sites
6
Patients with advanced, metastatic NSCLC that have not progressed on a standard of care immunotherapy regimen 6 months after initiation of first line treatment.
To evaluate the efficacy of shorter duration of standard of care treatment ([chemo]immunotherapy) for patients with metastatic NSCLC
Key facts
- Sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2025-09-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
To evaluate the efficacy of shorter duration of standard of care treatment ([chemo]immunotherapy) for patients with metastatic NSCLC
Secondary objectives 4
- Overall survival (Time from randomization to death of any cause with a maximum of 18 months after randomisation of last patient)
- Adverse events (The number and type of adverse events classified by CTCAE 5.0 grading in each arm)
- Quality of Life (EQ-5D-5L, QLQ-C30 and QLQ-LC19 questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation)
- Cost Utility analysis, Budget impact analysis (iMC, EQ-5D-5L questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation)
Conditions and MedDRA coding
Patients with advanced, metastatic NSCLC that have not progressed on a standard of care immunotherapy regimen 6 months after initiation of first line treatment.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Advanced, metastatic non-small cell lung cancer UICC stage IV
- Having received first line immunotherapy or first line (chemo)immunotherapy for 6 months ±2 weeks
- Response or stable disease according to RECIST 1.1 as determined by imaging no older than 3 weeks at moment of randomization
- Signed and dated informed consent.
- ECOG PS 0-2 and fit and willing to continue treatment with first line (chemo-)immunotherapy as deemed by the treating physician
Exclusion criteria 2
- Other systemic anti-cancer treatment for the disease under study other than the first line (chemo-)immunotherapy
- Any contra-indication (as per label) for treatment with immune checkpoint inhibitors
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Time to disease progression as measured by RECIST 1.1 or death due to any cause in each arm, where each patient is followed for progression for a maximum of 18 months after randomization.
Secondary endpoints 4
- Number of patients alive at 18 months after randomization of the last patient in each arm.
- The number and type of adverse events classified by CTCAE 5.0 grading in each arm.
- EQ-5D-5L, QLQ-C30 and QLQ-LC19 questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation.
- iMC, EQ-5D-5L questionnaire measured in each arm at baseline and every 3 months thereafter until progression with a maximum of 18 months after randomisation.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
KEYTRUDA 25 mg/mL concentrate for solution for infusion
PRD4323105 · Product
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF02 — -
- Marketing authorisation
- EU/1/15/1024/002
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALIMTA 500 mg powder for concentrate for solution for infusion
PRD291536 · Product
- Active substance
- Pemetrexed
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 500 mg/m2 milligram(s)/square meter
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BA04 — -
- Marketing authorisation
- EU/1/04/290/001
- MA holder
- ELI LILLY NEDERLAND B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Leids Universitair Medisch Centrum (LUMC)
- Sponsor organisation
- Leids Universitair Medisch Centrum (LUMC)
- Address
- Albinusdreef 2
- City
- Leiden
- Postcode
- 2333 ZA
- Country
- Netherlands
Scientific contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Egbert Smit
Public contact point
- Organisation
- Leids Universitair Medisch Centrum (LUMC)
- Contact name
- Egbert Smit
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 500 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Longziekten, Plesmanlaan 121, 1066 CX, Amsterdam
Haga Hospital
Longziekten, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Het Van Weel-Bethesda Ziekenhuis
Longziekten, Stationsweg 22, 3247 BW, Dirksland
Leids Universitair Medisch Centrum (LUMC)
Longziekten, Albinusdreef 2, 2333 ZA, Leiden
Gelre Hospitals
Longziekten, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
Albert Schweitzer Ziekenhuis
Longziekten, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1 Protocol 2025-520792-67 | 1.1 |
| Protocol (for publication) | D4 NL-NL Patient facing documents_questionnaire_EQ-5D-5L_self-complete | 1 |
| Protocol (for publication) | D4 NL-NL Patient facing documents_questionnaire_iMCQ | 1.1 |
| Protocol (for publication) | D4 NL-NL Patient facing documents_questionnaire_QLQ-C30 | 1 |
| Protocol (for publication) | D4 NL-NL Patient facing documents-questionnaire_QLQ-LC29 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1 NL-NL SIS and ICF redacted | 1.2 |
| Subject information and informed consent form (for publication) | L2 NL-NL Other subject information material text for websites | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Alimta | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2 SmPC Keytruda | 1 |
| Synopsis of the protocol (for publication) | D1 NL-EN Protocol synopsis 2025-520792-67 | 1.1 |
| Synopsis of the protocol (for publication) | D1 NL-NL Protocol synopsis 2025-520792-67 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-09 | Netherlands | Acceptable 2025-09-12
|
2025-09-12 |