Clinical trial • Phase III • Oncology|Immunology|Respiratory

TREMELIMUMAB for Non-small cell lung cancer (oligometastatic)

Phase III trial of TREMELIMUMAB for Non-small cell lung cancer (oligometastatic).

Overview

Trial Therapeutic Area
Oncology|Immunology|Respiratory
Trial Disease
Non-small cell lung cancer (oligometastatic)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody|Small molecule

Key dates

Initial CTIS Submission Date
09-08-2024
First CTIS Authorization Date
19-11-2024

Trial design

Randomised, open-label, immunotherapy-based standard of care alone (per european marketing authorization) versus immunotherapy-based standard of care plus radical local treatment (rlt) to up to 5 secondary lesions.-controlled Phase III trial across 22 sites in France.

Randomised
Yes
Open Label
Yes
Comparator
Immunotherapy-based standard of care alone (per European Marketing Authorization) versus immunotherapy-based standard of care plus radical local treatment (RLT) to up to 5 secondary lesions.
Target Sample Size
130

Eligibility

Recruits 130 Patients must understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures. The trial record flags vulnerable population selection, but inclusion criteria specify age > 18 years (no paediatric/assent procedures described). Consent is provided by the participant (ICF in French)..

Vulnerable Population
Patients must understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures. The trial record flags vulnerable population selection, but inclusion criteria specify age > 18 years (no paediatric/assent procedures described). Consent is provided by the participant (ICF in French).

Inclusion criteria

  • {"criterion_text":"-Histologically proven advanced oligometastatic stage IV NSCLC."}
  • {"criterion_text":"-Symptomatic lesions requiring urgent palliative radiation, is permitted prior to randomization. These treated lesions should be counted towards the total number of metastases at the time of enrolment."}
  • {"criterion_text":"-Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is permitted and BM count within the total number of 5 lesions. The patient would then be randomized to treatment of their remaining disease"}
  • {"criterion_text":"-Acceptable organ function for RLT"}
  • {"criterion_text":"-ECOG performance status (PS) 0-1."}
  • {"criterion_text":"-Measurable lesions according to RECIST V1.1 or evaluable disease on standard imaging,"}
  • {"criterion_text":"-Patient should understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures performed."}
  • {"criterion_text":"-Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 6 months after completing treatment/therapy."}
  • {"criterion_text":"-Patients affiliated to the social security system."}
  • {"criterion_text":"-Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations including follow-up."}
  • {"criterion_text":"-Aga > 18 years"}
  • {"criterion_text":"-NSCLC patients eligible first line immunotherapy-based SoC according to the European Marketing Authorization. PDL1 status available."}
  • {"criterion_text":"-Metastases eligible to RLT(minimally invasive surgery, SBRT and/or interventional radiology) according to the local multidisciplinary board (MTB): ≤5cm each in CT scan, excluding primary tumour."}
  • {"criterion_text":"-Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and FDG-PET"}

Exclusion criteria

  • {"criterion_text":"-Non-squamous NSCLC with targetable tumour mutations and approved first line targeted therapy (such as EGFR, ALK and ROS1)."}
  • {"criterion_text":"-Metastases not eligible to RLT: e.g. brainstem or diffuse serosal metastases (meningeal, pericardial, pleural, peritoneal, mesenteric) or that invades the gastrointestinal tract."}
  • {"criterion_text":"-Uncontrolled severe comorbidity, including but not limited to symptomatic interstitial lung disease or active infection."}
  • {"criterion_text":"-Prior therapy with T-cell costimulation or immune checkpoint-targeted agents within 1 year."}
  • {"criterion_text":"-Uncontrolled concomitant (<1-year) malignancy except adequately treated basal or squamous cell carcinoma of the skin, or in-situ carcinoma of any organ or in-situ melanoma of the skin."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-The primary endpoint is overall survival (OS).","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-PFS or iPFS according to RECIST 1.1 and iRECIST.","definition_or_measurement_approach":"Assessed according to RECIST 1.1 and iRECIST."}
  • {"endpoint_text":"-Cancer specific survival.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Type of relapses, local and distant control rates in both arms.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Acute/ late adverse events graded by CTCAE v5 (toxic death and serious adverse events).","definition_or_measurement_approach":"Adverse events graded using CTCAE v5, including toxic death and serious adverse events."}
  • {"endpoint_text":"-QoL according to EORTC QLQ-C30, QLQ-LC-13, EQ-5D-5L","definition_or_measurement_approach":"Quality of life measured using EORTC QLQ-C30, QLQ-LC13 and EQ-5D-5L instruments."}
  • {"endpoint_text":"-Clearance rate at 6 weeks and 4 months (before maintenance) of circulating tumour DNA assessed in plasma compared to value at baseline in the 2 arms.","definition_or_measurement_approach":"Circulating tumour DNA clearance assessed in plasma at 6 weeks and 4 months compared to baseline."}
  • {"endpoint_text":"-Economic evaluation: incremental cost per Quality-adjusted life year (QALY based on EQ-5D-5L measures), incremental net monetary benefit.","definition_or_measurement_approach":"Economic evaluation using EQ-5D-5L to derive QALYs and calculating incremental cost per QALY and incremental net monetary benefit."}
  • {"endpoint_text":"-Effect of RLT modality (minimally invasive surgery vs stereotactic body radiation therapy (SBRT) vs interventional radiology) on OS and local control.","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Impact of metastatic site (e.g., brain-only vs. others) on OS and local control.","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
130
Recruitment Window Months
24
Consent Approach
Informed consent must be provided by the participant: 'Patient should understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures performed.' Subject information and ICF documents (L1_ICF, L1_SIS) are provided; consent is completed in French. No assent or minor-specific consent procedures are described (trial limited to participants >18 years).

Geography

Total Number Of Sites
22
Total Number Of Participants
130

France

Latest Decision Or Authorization Date
09-04-2026
Number Of Sites
22
Number Of Participants
130

Sites

Site Name
Centr Georges Francois Leclerc
Department Name
Radiotherapy Department
Contact Person Name
etienne martin
Contact Person Email
emartin@cgfl.fr
Site Name
Institut de Cancérologie du Gard
Department Name
ONCOLOGIE
Contact Person Name
VAN HULST Sylvie
Contact Person Email
sylvie.vanhulst@chu-nimes.fr
Site Name
Centre Henri Becquerel
Department Name
ONCOLOGIE
Contact Person Name
THUREAU Sébastien
Site Name
Institut Gustave Roussy
Department Name
ONCOLOGIE
Contact Person Name
LEVY Antonin
Contact Person Email
antonin.levy@gustaveroussy.fr
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
ONCOLOGIE
Contact Person Name
KHALIFA Jonathan
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
pneumology (thoracic oncology unit)
Contact Person Name
Florian Guisier
Contact Person Email
florent.guisier@chu-rouen.fr
Site Name
Centre Hospitalier Intercommunal Creteil
Department Name
pneumology
Contact Person Name
Gaelle Rousseau Bussac
Site Name
Hospices Civils De Lyon
Department Name
pulmonology
Contact Person Name
Thomas Pierret
Contact Person Email
thomas.pierret@chu-lyon.fr
Site Name
Centre De Lutte Contre Le Cancer Eugene Marquis
Department Name
ONCOLOGIE
Contact Person Name
DUVERGE Loig
Contact Person Email
l.duverge@rennes.unicancer.fr
Site Name
Institut De Cancerologie De Lorraine
Department Name
ONCOLOGIE
Contact Person Name
MARCEL Johann
Contact Person Email
j.marcel@nancy.unicancer.fr
Site Name
Hospices Civils De Lyon
Department Name
ONCOLOGIE
Contact Person Name
PIERRET Thomas
Contact Person Email
thomas.pierret@chu-lyon.fr
Site Name
Centre Francois Baclesse
Department Name
ONCOLOGIE
Contact Person Name
CESAIRE Mathieu
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
radiology oncology
Contact Person Name
Francois Lucia
Contact Person Email
francois.lucia@chu-brest.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pulmonology and thoracic oncology department
Contact Person Name
Alexis Cortot
Contact Person Email
alexis.cortot@chu-lille.fr
Site Name
Centre Oscar Lambret
Department Name
ONCOLOGIE
Contact Person Name
LE TINIER Florence
Contact Person Email
f-letinier@o-lambert.fr
Site Name
Hospices Civils De Lyon
Department Name
pulmonology
Contact Person Name
Thomas Pierret
Contact Person Email
thomas.pierret@chu-lyon.fr
Site Name
Institut Sainte Catherine
Department Name
ONCOLOGIE
Contact Person Name
POUREL Nicolas
Contact Person Email
n.pourel@isc84.org
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pneumology, thoracic oncology and intensive respiratory care
Contact Person Name
Jacques Boutros
Contact Person Email
boutros.j@chu-nice.fr
Site Name
Groupe Hospitalier Public Du De L Oise
Department Name
ONCOLOGIE
Contact Person Name
HUERTAS Andres
Contact Person Email
andres.huertas@amethyst.fr
Site Name
Institut Curie
Department Name
ONCOLOGIE
Contact Person Name
LOO Maxime
Contact Person Email
maxime.loo@curie.fr
Site Name
Centre Antoine Lacassagne
Department Name
Specialist in Oncology and Radiotherapy
Contact Person Name
Jerome Doyen
Contact Person Email
jerome.doyen@nice.unicancer.fr
Site Name
Fondation Hopital Saint Joseph
Department Name
pneumo oncology and allergology department
Contact Person Name
Charles Naltet
Contact Person Email
cnaltet@ghpsj.fr

Sponsor

Primary sponsor

Full Name
Institut Gustave Roussy
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
IMJUDO 20 mg/ml concentrate for solution for infusion.
Active Substance
TREMELIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
75 mg
Investigational Product Name
PACLITAXEL SANDOZ 6 mg/ml, solution à diluer pour perfusion
Active Substance
PACLITAXEL
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
800 mg/m2
Investigational Product Name
Pemetrexed Accord 25 mg/ml concentrate for solution for infusion
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
2000 mg/m2
Investigational Product Name
CARBOPLATINE KABI 10 mg/ml, solution à diluer pour perfusion
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
300 mg
Investigational Product Name
IMFINZI 50 mg/mL concentrate for solution for infusion
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
10 mg/kg
Investigational Product Name
Tecentriq 840 mg concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
1200 mg
Investigational Product Name
YERVOY 5 mg/ml concentrate for solution for infusion
Active Substance
IPILIMUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
60 mg (total) / 1 mg/kg daily limit noted
Investigational Product Name
OPDIVO 10 mg/mL concentrate for solution for infusion.
Active Substance
NIVOLUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
21600 mg
Investigational Product Name
Cisplatine Accord 1 mg/ml concentraat voor oplossing voor infusie
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
2760 mg
Investigational Product Name
LIBTAYO 350 mg concentrate for solution for infusion.
Active Substance
CEMIPLIMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
350 mg
Investigational Product Name
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
Intravenous infusion
Route
Intravenous infusion
Authorisation Status
Authorised
Maximum Dose
24000 mg
Combination Treatment
Yes

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