Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Maintenance Pembrolizumab at Usual or Low doSE in non-squamous lung cancer: a non-inferiority study - PULSE |
| Participants (P) | Non-operable / non-irradiable stage III and stage IV non-squamous non-small cell lung cancer patients without progression to induction treatment with 3 or 4 cycles of pembrolizumab and platinum-pemetrexed chemotherapy. |
| Intervention (I) | Pembrolizumab 200 mg will be administered to patients as 30-minutes IV infusion every 6 weeks (Q6W) plus, In the absence of contra-indication pemetrexed 500 mg/m2 will be administered to patients as 10-minutes IV infusion every 3 weeks (Q3W). Treatment will be administered until disease progression by RECIST 1.1 criteria or as a maximum of 35 cycles every 3 weeks or 17 cycles every 6 weeks (maximum 2 years, taking into account induction phase) |
| Control (C) | Pembrolizumab 200 mg will be administered to patients as 30-minutes IV infusion every 3 weeks (Q3W) or 400 mg as 30-minutes IV infusion every 6 weeks plus, In the absence of contra-indication pemetrexed 500 mg/m2 will be administered to patients as 10-minutes IV infusion every 3 weeks (Q3W). Treatment will be continued until disease progression by RECIST 1.1 criteria or as a maximum of 35 cycles every 3 weeks or 17 cycles every 6 weeks (maximum 2 years, taking into account induction phase). |
| Outcome (O) | Overall survival |
| Trial Design | A randomized non-inferiority phase III clinical trial. |
| Sample Size | For the study 664 events are required. This number of events corresponds to inclusion of 1108 patients. Taking into account for 5% patients with non-usable data, 1166 patients should be randomized. |
| Trial duration | 54 months from FPI-BE to CSR |
| Budget | € 1,430,000 |
Trial team
| Sponsor / Belgian Coordinating Centre | Gustave Roussy, Villejuif, France / Cliniques Universitaire St Luc |
| Chief Investigator / National Investigator | Prof Benjamin Besse MD, PhD / Prof Frank Aboubakar Nana MD, PhD |
| External partners | Spain and Luxembourg |
| Number of participating sites in Belgium | 12 |
DOCUMENTS
References
Clinicaltrials.gov: https://classic.clinicaltrials.gov/ct2/show/NCT05692999
Webpage:
Funding scheme
