NCT04339218 Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma
| NCT ID | NCT04339218 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institut Bergonié |
| Condition | Lung Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2020-08-28 |
| Primary Completion | 2026-08-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 214 participants in total. It began in 2020-08-28 with a primary completion date of 2026-08-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed non-small lung adenocarcinoma. 2. Metastatic disease. 3. Treatment with pembrolizumab in combination with pemetrexed-carboplatin as per market authorization. 4. At least two target lesions (RECIST1.1), measurable with CT or MRI : 1. One target lesion that is amenable for accurate repeated measurements, 2. One target lesion (15-40 mm) that is amenable for cryoablation treatment including lung, kidney, adrenal, soft tissue and lytic bone lesions. Liver and sclerotic bone lesions are not allowed to be treated by cryoablation. 5. Age ≥ 18. 6. Performance status ≤ 2. 7. Women of childbearing potential must have a negative serum pregnancy test prior to registration. 8. Recovery to grade ≤ 1 from any adverse event derived from previous treatment (excluding alopecia) 9. Patients with a social security in compliance with the French law (Loi Jardé). 10. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures. 11. Voluntarily signed and dated written informed consents prior to any study specific procedure. Exclusion Criteria: 1. Squamous cell tumors and other than adenocarcinoma. 2. Prior systemic treatment for advanced non-small cell lung cancer (except adjuvant therapy after complete resection). 3. Current or prior use of immunosuppressive medication including any use of oral glucocorticoids, within 21 days before the first dose of pembrolizumab. 4. Known contra-indication and/or hypersensitivity to PD1/PD-L1 antagonist and/or cytotoxic therapy. 5. Known contra-indication to cryoablation. 6. Abnormal coagulation contraindicating biopsy. 7. Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma or incidentally discovered good prognosis prostate cancer (T stage \< pT3 and Gleason ≤ 7). 8. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 9. Subjects who participated in an investigational drug or device study within 28 days prior to study entry. 10. Known infection with HIV, hepatitis B, or hepatitis C. 11. Females who are pregnant or breast-feeding. 12. Men or women refusing contraception. 13. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. 14. Previous enrolment in the present study. 15. Individuals deprived of liberty or placed under legal guardianship.
Contact & Investigator
Jean PALUSSIERE, MD
PRINCIPAL INVESTIGATOR
Institut Bergonié
Frequently Asked Questions
Who can join the NCT04339218 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04339218 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 214 participants.
Is NCT04339218 currently recruiting?
Yes, NCT04339218 is actively recruiting participants. Contact the research team at j.palussiere@bordeaux.unicancer.fr for enrollment information.
Where is the NCT04339218 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT04339218 clinical trial?
NCT04339218 is sponsored by Institut Bergonié. The principal investigator is Jean PALUSSIERE, MD at Institut Bergonié. The trial plans to enroll 214 participants.