RecruitingPhase 3NCT04339218

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in 1st-line Treatment for Patients With Metastatic Lung Adenocarcinoma

Cryoablation in Combination (or Not) With Pembrolizumab and Pemetrexed-carboplatin in First-line Treatment for Patients With Metastatic Lung Adenocarcinoma: A Randomized Phase III Study


Sponsor

Institut Bergonié

Enrollment

214 participants

Start Date

Aug 28, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding cryoablation — a procedure that uses extreme cold to destroy a tumor — to standard first-line immunotherapy and chemotherapy improves treatment outcomes for people with metastatic lung adenocarcinoma (a subtype of lung cancer that has spread). Researchers believe destroying one tumor with cold may help the immune system attack other tumors elsewhere in the body. **You may be eligible if...** - You are 18 years or older - You have confirmed metastatic lung adenocarcinoma (not squamous cell or other types) - You are receiving pembrolizumab combined with pemetrexed and carboplatin as first-line treatment - You have at least two measurable tumors: one suitable for repeated measurement and one suitable for cryoablation (15–40 mm in the lung, kidney, adrenal gland, soft tissue, or bone) - You are in good enough condition (performance status of 2 or less) **You may NOT be eligible if...** - You have squamous cell lung cancer - You have already received systemic treatment for advanced lung cancer - You have taken immune-suppressing drugs (including oral steroids) in the 3 weeks before starting - The tumors suitable for cryoablation are in the liver or sclerotic bone - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECryoablation

Cryoablation will be performed by a specialized radiologist, percutaneously, ie "through the skin". The operation is performed under general anesthesia, under the guidance of the scanner. The images from the scanner make it possible to precisely insert and place a needle at the level of the tumor to be treated. Intense cold will be produced by the needle and will destroy the cancer cells by freezing (temperatures of -40 °C). Freezing is localized to the tumor, the rest of the organ will not suffer from the cold. The aftermath of the intervention causes only minimal pain and in most cases does not require pain treatment. As the operation is minimally traumatic, the risk of complications is low. Hospitalization is around twenty-four hours and usual or professional activities can be resumed very quickly.

DRUGPembrolizumab

Pembrolizumab will be prescribed and administered at the dose recommended by market authorization.

DRUGPemetrexed

Pemetrexed will be prescribed and administered at the dose recommended by market authorization.

DRUGCarboplatin

Carboplatin will be prescribed and administered at the dose recommended by market authorization.


Locations(1)

Institut Bergonié

Bordeaux, Gironde, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04339218


Related Trials