Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
- Registration Number
- NCT06219317
- Brief Summary
This is a multi-center, double-blind, placebo-controlled randomized phase II study to assess whether continuation of cemiplimab treatment (for up to 12 months) increases progression-free survival (PFS) as compared to placebo in patients with a stage IV, synchronous, oligometastatic non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of cemiplimab with our without platinum-based chemotherapy and radical treatment.
Eligible patients are randomized with a 1:1 ratio to either the cemiplimab or placebo group and will undergo disease assessment (e.g. imaging, blood tests) at regular follow-up visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 136
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (saline solution) IV every 3 weeks for up to 12 months or until progression or discontinuation Cemiplimab Cemiplimab Cemiplimab IV 350 mg every 3 weeks for up to 12 months or until progression or discontinuation
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 9 years from first patient randomized PFS is defined as the time from the date of randomization until first occurrence of any of the following events:
* Disease progression at any site: loco-regional progression/recurrence (related to primary tumour); progression/recurrence of oligometastatic lesions initially present at registration
* Development of new metastatic lesions
* Death due to any cause.
Disease progression will be assessed using the RECIST 1.1 criteria.
- Secondary Outcome Measures
Name Time Method Time to disease progression 6 years from first patient randomized Time to disease progression is defined as the time from the date of randomization to the date of first occurrence of any of the following events:
* Disease progression at any site: loco-regional progression/recurrence (related to primary tumour); progression/recurrence of oligometastatic lesions initially present at registration
* Development of new metastatic lesions
* Death due to progressive disease.AEs according to NCI-CTCAE v5.0 and SAEs 9 years from first patient randomized This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, for adverse event reporting
Time to development of new metastatic lesions 6 years from first patient randomized Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:
* Development of new metastatic lesions not initially present at registration,
* Death due to progressive disease.Patient reported QoL as measured by the IL316 questionnaire - questions from EORTC QLQ-LC29 questionnaire 9 weeks from last patient last treatment This questionnaire includes 8 questions from the EORTC lung cancer specific module (QLQ-LC29) were selected: the coughing domain scale (2 questions), the dyspnoea scale (3 questions), chest pain (1 question) and physical capabilities (1 question).
The questions follow the same structure using a 4-point Likert scale with responses from "not at all" to "very much" and are scored according to the scale structure of their respective source questionnaire.Overall survival (OS) 6 years from first patient randomized OS is defined as the time from the date of randomization until date of death, for any reason
Patient reported QoL as measured by the EORTC QLQ-C30 questionnaire 9 weeks from last patient last treatment This questionnaire is composed of 30 individual questions that are scored into 15 multi-item and single-item scales according the EORTC scoring manual. These include five functional scales (physical, role, emotional, social, and cognitive), nine symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties) and a global health status/QoL scale.
The functional and symptom questions follow the same structure using a 4-point Likert scale with responses from "not at all" to "very much".
The questions on global health an QoL use a 7-point Likert scale with responses from "very poor" to "excellent".Patient reported QoL as measured by the IL316 questionnaire - self assessment of treatment side effects 9 weeks from last patient last treatment This questionnaire includes self-assessment of treatment side effects, most notable pneumonitis.
The questions follow the same structure using a 4-point Likert scale with responses from "not at all" to "very much" and are scored according to the scale structure of their respective source questionnaire.Time to progression in oligometastatic lesions initially present at registration 6 years from first patient randomized Time to progression in oligometastatic lesions initially present at registration is the time interval from the date of randomization to the date of first progression/recurrence in at least one of the oligometastatic lesions initially present at registration
Patient reported QoL as measured by the IL316 questionnaire - questions from EORTC QLQ-ELD14 questionnaire 9 weeks from last patient last treatment This questionnaire includes 1 item from the validated QLQ-ELD14 questionnaire to include self-assessment on treatment burden: "How much has your treatment been a burden to you?" The questions follow the same structure using a 4-point Likert scale with responses from "not at all" to "very much" and are scored according to the scale structure of their respective source questionnaire.
Trial Locations
- Locations (17)
Fondazione IRCCS - Policlinico San Matteo
🇮🇹Pavia, Italy
AUSL Della Romagna - Ospedale Santa Maria delle Croci
🇮🇹Ravenna, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Italy
Azienda Ospedaliero - Universitaria "Santa Maria della Misericordia" di Udine
🇮🇹Udine, Italy
Academisch Ziekenhuis Maastricht
🇳🇱Maastricht, Netherlands
Hospital De La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
UOMi Cancer Center
🇪🇸Barcelona, Spain
Hospital Quironsalud Sagrado Corazon
🇪🇸Sevilla, Spain
University Hospital Virgen del Rocio
🇪🇸Sevilla, Spain
Cliniques Universitaires Saint-Luc
🇧🇪Brussels, Belgium
CHU Helora Pole Hospitalier Jolimont
🇧🇪Haine-Saint-Paul, Belgium
CHU Mont Godinne - UCL Namur
🇧🇪Yvoir, Belgium
CH de La Cote Basque - Saint Leon
🇫🇷Bayonne, France
Institut Paoli-Calmettes
🇫🇷Marseille, France
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, France
ASST Ovest Milanese - Legnano
🇮🇹Legnano, Italy
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
🇮🇹Legnano, Italy