Actively Recruiting
Cryoablation Combined With Pembrolizumab and Pemetrexed-Carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study
Led by Institut Bergonié · Updated on 2026-01-30
214
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding cryoablation to standard treatment with pembrolizumab, pemetrexed, and carboplatin improves one-year survival in patients with metastatic lung adenocarcinoma. This phase III, multicenter, open-label trial compares two groups: one receiving cryoablation plus standard drugs and the other receiving only the standard drug combination. The study investigates the possible survival benefit of combining these treatments for this advanced lung cancer. Participants are randomly assigned to one of two arms. The experimental arm receives cryoablation of one eligible visceral or bone metastasis (excluding liver and sclerotic bone lesions) alongside pembrolizumab and pemetrexed-carboplatin given according to approved dosing. Cryoablation is performed within 6 weeks after starting pembrolizumab. The control arm receives pembrolizumab, pemetrexed, and carboplatin without cryoablation. Treatment continues until disease progression, unacceptable toxicity, or other reasons for stopping. Participants undergo tumor assessments at baseline and every 9 weeks using RECIST v1.1 criteria. Blood samples and optional biopsies are collected at specified times including before treatment and at progression. Safety is monitored up to 90 days after the last immunotherapy or 12 months of treatment. Follow-up continues for up to 36 months after randomization to track tumor response, survival, and quality of life. The primary outcome is one-year overall survival rate, with multiple secondary outcomes including response rates and adverse events.
CONDITIONS
Brief 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...
- Histologically or cytologically confirmed non-small cell lung adenocarcinoma
- Metastatic disease
- Planned treatment with pembrolizumab combined with pemetrexed-carboplatin as per market authorization
- At least two measurable target lesions by CT or MRI, including one amenable to cryoablation (excluding liver and sclerotic bone lesions)
- Age 18 years or older
- Performance status of 2 or less
- Negative pregnancy test for women of childbearing potential
- Recovery to grade 1 or less from prior treatment adverse events (except hair loss)
- Compliance with French social security law
- Ability and willingness to follow study visits, treatment plans, and procedures
- Signed informed consent
You will not qualify if you...
- Squamous cell tumors and non-adenocarcinoma types
- Prior systemic treatment for advanced non-small cell lung cancer (except adjuvant therapy after complete resection)
- Use of immunosuppressive medication including oral glucocorticoids within 21 days before first pembrolizumab dose
- Known contraindications or hypersensitivity to PD1/PD-L1 antagonist or cytotoxic therapy
- Contraindications to cryoablation
- Abnormal blood clotting preventing biopsy
- Other malignancies diagnosed or treated within 2 years except certain treated cancers
- Active uncontrolled infections requiring systemic treatment
- Participation in another investigational drug or device study within 28 days
- Known HIV, hepatitis B, or hepatitis C infection
- Pregnant or breastfeeding women
- Refusal to use contraception
- Other diseases or conditions posing unacceptable risk or interfering with study
- Previous enrollment in this study
- Legal guardianship or deprivation of liberty
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person)
Duration - Up to 12 months or until disease progression or unacceptable toxicity
Participants receive either cryoablation combined with pembrolizumab and pemetrexed-carboplatin, or pembrolizumab and pemetrexed-carboplatin alone, as prescribed by market authorization. Pembrolizumab treatment begins within 7 days after randomization and cryoablation is performed within 6 weeks after the first pembrolizumab administration for those assigned to the experimental arm.
Baseline visit, then visits every 3 weeks for drug administration and assessments, with tumor assessments every 9 weeks
Duration - Up to 36 months after randomization
After treatment ends, participants are followed up for survival and tumor response. Assessments occur every 3 months until loco-regional relapse or metastasis, then every 6 months until death or study end for up to 36 months after randomization.
Quarterly visits for up to 36 months, then biannual visits if relapse occurs
Trial Site Locations
Total: 1 location
1
Institut Bergonié
Bordeaux, Gironde, France, 33076
Actively Recruiting
Research Team
J
Jean PALUSSIERE, MD
S
Simone MATHOULIN-PELISSIER, MD, PhD
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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