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

Sponsor
Institut Bergonié
Study ID
NCT04339218
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation — DEVICE
    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.
  • Pembrolizumab — DRUG
    Pembrolizumab will be prescribed and administered at the dose recommended by market authorization.
  • Pemetrexed — DRUG
    Pemetrexed will be prescribed and administered at the dose recommended by market authorization.
  • Carboplatin — DRUG
    Carboplatin will be prescribed and administered at the dose recommended by market authorization.

Study Details

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.

Key Dates

First listed
Apr 9, 2020
Start date
Aug 28, 2020
Status verified
Jan 2026
Primary completion
Aug 27, 2026
Completion
Aug 27, 2028

Study Design

Enrollment
214 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm Cryoablation+pembrolizumab-pemetrexed-carboplatin
    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.
  • Active Comparator: Arm pembrolizumab-pemetrexed-carboplatin
    Combination of Pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.

Primary Outcome Measure

1-year overall survival rate [ Time Frame: 1 year ]

Central Contacts

Related Studies