Immunotherapy Consolidation After Radical Treatment of Synchronous Oligo-metastatic NSCLC

NCT06219317 | Recruiting Phase 2 DMC

• 1 other identifier: EORTC-2029-LCG
• Study Type: interventional
• Target: 136
• Locations: 5 countries
• Sites: 16

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.

Conditions

NSCLC Stage IV

Keywords

NSCLC; cemiplimab; immunotherapy; oligometastatic disease; radical treatment

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  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.

  9 years from first patient randomized

Secondary Outcomes (9)

• Overall survival (OS)

  6 years from first patient randomized

• Time to disease progression

  6 years from first patient randomized

• Time to development of new metastatic lesions

  6 years from first patient randomized

• Time to progression in oligometastatic lesions initially present at registration

  6 years from first patient randomized

• AEs according to NCI-CTCAE v5.0 and SAEs

  9 years from first patient randomized

Other Outcomes (4)

• Tumour molecular profile (NGS panel, WES (including germline), RNAseq)

  6 years from first patient randomized

• ctDNA analysis

  6 years from first patient randomized

• Circulating biomarkers such as cytokines, or auto-Ab

  6 years from first patient randomized

Study Arms (2)

Cemiplimab

EXPERIMENTAL

Cemiplimab IV 350 mg every 3 weeks for up to 12 months or until progression or discontinuation

Drug: Cemiplimab

Placebo

PLACEBO COMPARATOR

Placebo (saline solution) IV every 3 weeks for up to 12 months or until progression or discontinuation

Drug: Placebo

Interventions

Cemiplimab DRUG

Cemiplimab is provided in a 10 ml glass vial

Cemiplimab

Placebo DRUG

standard saline solution

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (16)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

RECRUITING

CHU Helora Pole Hospitalier Jolimont

Haine-Saint-Paul, Belgium

RECRUITING

CHU Mont Godinne - UCL Namur

Yvoir, Belgium

RECRUITING

CH de La Cote Basque - Saint Leon

Bayonne, France

RECRUITING

Institut Paoli-Calmettes

Marseille, France

RECRUITING

Groupe Hospitalier Paris Saint Joseph

Paris, France

NOT YET RECRUITING

ASST Ovest Milanese - Legnano

Legnano, Italy

NOT YET RECRUITING

Azienda Unita Locale Socio-Sanitaria N. 9-Mater Salutis Hospital

Legnano, Italy

RECRUITING

Fondazione IRCCS - Policlinico San Matteo

Pavia, Italy

NOT YET RECRUITING

AUSL Della Romagna - Ospedale Santa Maria delle Croci

Ravenna, Italy

RECRUITING

Azienda Ospedaliero - Universitaria "Santa Maria della Misericordia" di Udine

Udine, Italy

RECRUITING

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

RECRUITING

Hospital De La Santa Creu I Sant Pau

Barcelona, Spain

RECRUITING

UOMi Cancer Center

Barcelona, Spain

RECRUITING

Hospital Quironsalud Sagrado Corazon

Seville, Spain

RECRUITING

University Hospital Virgen del Rocio

Seville, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dirk de Ruysscher, MD

  Maastro Clinic - Maastricht Radiation Oncology, Maastricht, Netherlands

  STUDY CHAIR

• Frank Aboubakar Nana, MD

  Cliniques Universitaires Saint-Luc, Brussels, Belgium

  STUDY CHAIR

Central Study Contacts

EORTC

CONTACT

+32 2 774 1611; eortc@eortc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: January 14, 2025
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3); ES (4); IT (5); BE (3); NL (1)