Actively Recruiting
Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
Led by Institut Bergonié · Updated on 2026-01-30
214
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to compare the one-year survival benefit of the association of cryoablation-pembrolizumab-pemetrexed-carboplatin versus pembrolizumab-pemetrexed-carboplatin in metastatic lung adenocarcinoma patients. This is a multicenter, prospective, open-labeled, 2-arm comparative randomized (1:1) phase III trial. Patients will be randomized with a 1:1 ratio into: * Arm A (experimental arm): cryoablation of one visceral lesion or bone metastasis excluding liver and sclerotic bone metastases combined with pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. * Arm B (standard arm): pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization. Pembrolizumab and pemetrexed-carboplatin will be prescribed and administered at the dose recommended by market authorization. Cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab. No treatment switching permitted.
CONDITIONS
Official Title
Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with metastatic non-small cell lung adenocarcinoma confirmed by tissue or cell analysis
- Planned treatment with pembrolizumab combined with pemetrexed-carboplatin as approved
- At least two measurable target lesions on CT or MRI, including one lesion suitable for cryoablation (lung, kidney, adrenal, soft tissue, or lytic bone; excluding liver and sclerotic bone lesions)
- Performance status of 2 or less
- Negative pregnancy test for women of childbearing potential before registration
- Recovery to mild or less severe status (grade 1 or lower) from prior treatment side effects, except hair loss
- Possession of social security compliant with French law
- Ability and willingness to follow scheduled visits, treatments, lab tests, and study procedures
- Signed informed consent before any study-specific procedure
You will not qualify if you...
- Squamous cell tumors or non-adenocarcinoma lung cancers
- Previous systemic treatment for advanced non-small cell lung cancer except prior adjuvant therapy after full tumor removal
- Use of immunosuppressive drugs including oral steroids within 21 days before first pembrolizumab dose
- Known allergy or contraindication to PD1/PD-L1 inhibitors or chemotherapy drugs used
- Contraindications to cryoablation treatment
- Blood clotting problems preventing biopsy
- Other cancers diagnosed or treated in past 2 years except certain skin or prostate cancers with good prognosis
- Active uncontrolled infections needing systemic treatment
- Participation in another investigational drug or device study within 28 days before enrollment
- Known infection with HIV, hepatitis B, or hepatitis C
- Pregnant or breastfeeding women
- Refusal to use contraception by men or women
- Other diseases or conditions that could interfere with study or pose risks as judged by investigator
- Previous enrollment in this study
- Individuals under legal guardianship or deprived of liberty
AI-Screening
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Trial Site Locations
Total: 1 location
1
Institut Bergonié
Bordeaux, Gironde, France, 33076
Actively Recruiting
Research Team
J
Jean PALUSSIERE, MD
CONTACT
S
Simone MATHOULIN-PELISSIER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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