Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC
NCT ID: NCT06219317
Last Updated: 2025-07-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE2
Total Enrollment
136 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-01-14
Study Completion Date
2030-01-31
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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NSCLC Stage IV
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Cemiplimab
Cemiplimab IV 350 mg every 3 weeks for up to 12 months or until progression or discontinuation
Group Type
EXPERIMENTAL
Cemiplimab
Intervention Type
DRUG
Cemiplimab is provided in a 10 ml glass vial
Placebo
Placebo (saline solution) IV every 3 weeks for up to 12 months or until progression or discontinuation
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
standard saline solution
Interventions
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Cemiplimab
Cemiplimab is provided in a 10 ml glass vial
Intervention Type
DRUG
Placebo
standard saline solution
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Histologic or cytologic confirmation of NSCLC. If small-cell elements present, participant will be ineligible.
* Synchronous oligometastatic disease at diagnosis - and still oligometastatic at registration into the study - defined as maximum 5 metastases, in maximum 3 organs. Hilar, mediastinal and/or supraclavicular lymph nodes are not considered as metastases.
* Age at registration ≥18 years
* Eastern Cooperative Oncology Group performance status (ECOG PS)/ World Health Organization (WHO) 0-1.
* Hepatic function:
* Serum total bilirubin ≤1.5x upper limit of normal (ULN), or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3x ULN (or ≤5x ULN, if liver metastases)
* Renal function:
* Glomerular filtration rate (GFR) based on the modification of diet in renal disease (MDRD) equation ≥30 mL/min
* Bone marrow function:
* Hemoglobin ≥9.0 g/dL
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* Women of childbearing potential (WOCBP) must have a negative serum or highly sensitive urine pregnancy test within 7 days prior to the first dose of treatment.
Note: Women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression, or other reasons.
* Patients of childbearing / reproductive potential should agree to use adequate birth control measures, as defined by the protocol, during the study treatment period and for:
* At least 6 months after the last dose of pemetrexed-if pemetrexed was administered.
* At least 6 months after the last dose of cemiplimab/placebo. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods are detailed in Appendix Y.
* Women who are breast feeding should discontinue nursing prior to the first dose of study treatment and until:
* At least 6 months after the last dose of pemetrexed, if pemetrexed was administered.
* At least 6 months after the last dose of cemiplimab/placebo.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Stable disease, partial or complete response according to RECIST v.1.1 after 4 cycles of induction treatment and radical treatment of all residual disease (if applicable). Patients with progressive disease will be excluded.
* Anticipated life expectancy \>12 weeks
* Hepatic function:
* Serum total bilirubin ≤1.5x ULN (or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome)
* AST and/or ALT ≤3x ULN (or ≤5x ULN, if liver metastases)
* Renal function:
* GFR based on MDRD equation ≥30 mL/min
* Bone marrow function:
* Hemoglobin ≥9.0 g/dL
* ANC ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* WOCBP must have a negative serum or highly negative urine pregnancy test within 7 days prior to the first dose of consolidation treatment.
* Synchronous oligometastatic disease at diagnosis - and still oligometastatic at registration into the study - defined as maximum 5 metastases, in maximum 3 organs. Hilar, mediastinal and/or supraclavicular lymph nodes are not considered as metastases.
* Age at registration ≥18 years
* Eastern Cooperative Oncology Group performance status (ECOG PS)/ World Health Organization (WHO) 0-1.
* Hepatic function:
* Serum total bilirubin ≤1.5x upper limit of normal (ULN), or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3x ULN (or ≤5x ULN, if liver metastases)
* Renal function:
* Glomerular filtration rate (GFR) based on the modification of diet in renal disease (MDRD) equation ≥30 mL/min
* Bone marrow function:
* Hemoglobin ≥9.0 g/dL
* Absolute neutrophil count (ANC) ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* Women of childbearing potential (WOCBP) must have a negative serum or highly sensitive urine pregnancy test within 7 days prior to the first dose of treatment.
Note: Women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, with the exception of those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, low body weight, ovarian suppression, or other reasons.
* Patients of childbearing / reproductive potential should agree to use adequate birth control measures, as defined by the protocol, during the study treatment period and for:
* At least 6 months after the last dose of pemetrexed-if pemetrexed was administered.
* At least 6 months after the last dose of cemiplimab/placebo. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods are detailed in Appendix Y.
* Women who are breast feeding should discontinue nursing prior to the first dose of study treatment and until:
* At least 6 months after the last dose of pemetrexed, if pemetrexed was administered.
* At least 6 months after the last dose of cemiplimab/placebo.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Stable disease, partial or complete response according to RECIST v.1.1 after 4 cycles of induction treatment and radical treatment of all residual disease (if applicable). Patients with progressive disease will be excluded.
* Anticipated life expectancy \>12 weeks
* Hepatic function:
* Serum total bilirubin ≤1.5x ULN (or ≤3x ULN, if liver metastases or in patients with history of Gilbert syndrome)
* AST and/or ALT ≤3x ULN (or ≤5x ULN, if liver metastases)
* Renal function:
* GFR based on MDRD equation ≥30 mL/min
* Bone marrow function:
* Hemoglobin ≥9.0 g/dL
* ANC ≥1.5 x 109/L
* Platelet count ≥100 x 109/L
* WOCBP must have a negative serum or highly negative urine pregnancy test within 7 days prior to the first dose of consolidation treatment.
Exclusion Criteria
* Presence of malignant pleural, pericardial and/or peritoneal effusion.
* Presence of leptomeningeal carcinomatosis.
* Tumour known to be positive for EGFR exon 19 or 21 mutations, ALK translocations or ROS1 fusions.
* Prior pneumonectomy, radiotherapy (including mediastinal radiotherapy), chemotherapy, immune-check inhibitors or targeted therapy for lung cancer within the last 3 years before registration.
* Previously treated brain metastases that are radiologically non-stable.
Notes:
* Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate. These treated brain metastasis will count as metastasis in the definition of oligometastatic disease.
* Symptomatic brain metastases should be treated with surgery and/or stereotactic radiotherapy/ radiosurgery as soon as possible after diagnosis. If surgery is considered it must be applied before enrolment. Radiotherapy can be performed at any time.
* History of any solid or hematological malignancy in the past 3 years before registration.
Exceptions include patients who underwent successful definitive treatment of basal or squamous cell carcinoma of the skin, or any in-situ carcinoma(s).
* Any uncontrolled, intercurrent illness or clinical situation that would, in the judgment of investigator, limit compliance with study requirements.
* Any uncontrolled active infection, defined as an infection ≥ grade 3 according to CTCAE version 5.0.
* Any autoimmune disease that has required systemic treatment in the past 2 years (defined as any use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (e.g., thyroxine for hypothyroidism or insulin for type I diabetes) is not considered a form of systemic treatment.
The following treatments are allowed:
* Intranasal, inhaled and topical steroids as well as local steroid injections (e.g., intra articular injection).
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
* Systemic corticosteroid replacement therapy for adrenal or pituitary insufficiency.
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* Known active hepatitis B or C, defined as a positive HBV surface antigen (HBsAg) result or positive HCV RNA.
* Known active HIV infection, defined as \>200 copies of HIV per ml of blood.
* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or history of non-infectious pneumonitis that required systemic glucocorticoids to assist with management.
A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥12 months prior to registration.
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab.
Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included.
* Participation in any other clinical study involving an investigational drug or device within 4 weeks before registration.
* History of documented allergic reaction or acute hypersensitivity reaction attributed to antibody treatments.
* Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
2. At randomization Prior to treatment allocation for the consolidation phase an additional set of selection criteria need to be met and stratification factors provided.
• Use of immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab/placebo. Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included.
* Presence of leptomeningeal carcinomatosis.
* Tumour known to be positive for EGFR exon 19 or 21 mutations, ALK translocations or ROS1 fusions.
* Prior pneumonectomy, radiotherapy (including mediastinal radiotherapy), chemotherapy, immune-check inhibitors or targeted therapy for lung cancer within the last 3 years before registration.
* Previously treated brain metastases that are radiologically non-stable.
Notes:
* Patients with previously treated brain metastases, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention, can participate. These treated brain metastasis will count as metastasis in the definition of oligometastatic disease.
* Symptomatic brain metastases should be treated with surgery and/or stereotactic radiotherapy/ radiosurgery as soon as possible after diagnosis. If surgery is considered it must be applied before enrolment. Radiotherapy can be performed at any time.
* History of any solid or hematological malignancy in the past 3 years before registration.
Exceptions include patients who underwent successful definitive treatment of basal or squamous cell carcinoma of the skin, or any in-situ carcinoma(s).
* Any uncontrolled, intercurrent illness or clinical situation that would, in the judgment of investigator, limit compliance with study requirements.
* Any uncontrolled active infection, defined as an infection ≥ grade 3 according to CTCAE version 5.0.
* Any autoimmune disease that has required systemic treatment in the past 2 years (defined as any use of disease modifying agents, corticosteroids or immunosuppressive drugs).
Replacement therapy (e.g., thyroxine for hypothyroidism or insulin for type I diabetes) is not considered a form of systemic treatment.
The following treatments are allowed:
* Intranasal, inhaled and topical steroids as well as local steroid injections (e.g., intra articular injection).
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent.
* Systemic corticosteroid replacement therapy for adrenal or pituitary insufficiency.
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* Known active hepatitis B or C, defined as a positive HBV surface antigen (HBsAg) result or positive HCV RNA.
* Known active HIV infection, defined as \>200 copies of HIV per ml of blood.
* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or history of non-infectious pneumonitis that required systemic glucocorticoids to assist with management.
A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥12 months prior to registration.
• Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab.
Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included.
* Participation in any other clinical study involving an investigational drug or device within 4 weeks before registration.
* History of documented allergic reaction or acute hypersensitivity reaction attributed to antibody treatments.
* Sensitivity to any of the study interventions, or components thereof, or other allergy that, in the opinion of the investigator, contraindicates participation in the study.
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial
2. At randomization Prior to treatment allocation for the consolidation phase an additional set of selection criteria need to be met and stratification factors provided.
• Use of immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 2 weeks prior to the first dose of cemiplimab/placebo. Patients who require brief courses of steroids (e.g., as prophylaxis for imaging studies due to hypersensitivity to contrast agents) can be included.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Dirk de Ruysscher, MD
Role: STUDY_CHAIR
Maastro Clinic - Maastricht Radiation Oncology, Maastricht, Netherlands
Frank Aboubakar Nana, MD
Role: STUDY_CHAIR
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Locations
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Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Site Status
RECRUITING
CHU Helora Pole Hospitalier Jolimont
Haine-Saint-Paul, , Belgium
Site Status
RECRUITING
CHU Mont Godinne - UCL Namur
Yvoir, , Belgium
Site Status
NOT_YET_RECRUITING
CH de La Cote Basque - Saint Leon
Bayonne, , France
Site Status
RECRUITING
Institut Paoli-Calmettes
Marseille, , France
Site Status
NOT_YET_RECRUITING
Groupe Hospitalier Paris Saint Joseph
Paris, , France
Site Status
NOT_YET_RECRUITING
ASST Ovest Milanese - Legnano
Legnano, , Italy
Site Status
NOT_YET_RECRUITING
Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital
Legnano, , Italy
Site Status
RECRUITING
Fondazione IRCCS - Policlinico San Matteo
Pavia, , Italy
Site Status
NOT_YET_RECRUITING
AUSL Della Romagna - Ospedale Santa Maria delle Croci
Ravenna, , Italy
Site Status
NOT_YET_RECRUITING
Istituto Clinico Humanitas
Rozzano, , Italy
Site Status
NOT_YET_RECRUITING
Azienda Ospedaliero - Universitaria "Santa Maria della Misericordia" di Udine
Udine, , Italy
Site Status
NOT_YET_RECRUITING
Academisch Ziekenhuis Maastricht
Maastricht, , Netherlands
Site Status
RECRUITING
Hospital De La Santa Creu I Sant Pau
Barcelona, , Spain
Site Status
RECRUITING
UOMi Cancer Center
Barcelona, , Spain
Site Status
RECRUITING
Hospital Quironsalud Sagrado Corazon
Seville, , Spain
Site Status
RECRUITING
University Hospital Virgen del Rocio
Seville, , Spain
Site Status
RECRUITING
Countries
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Belgium
France
Italy
Netherlands
Spain
Central Contacts
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Other Identifiers
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EORTC-2029-LCG
Identifier Type: -
Identifier Source: org_study_id
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