A Phase 3 interventional study of Cryoablation and Pembrolizumab in Lung Adenocarcinoma and Cryotherapy Effect, sponsored by Institut Bergonié. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-30.
Sponsored by Institut Bergonié · Phase 3, Interventional, and Treatment
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Among 22 studies in Adenocarcinoma of Lung with a site in France — 1 open to participants now, 2 under way, 1 of them phase 3. Adenocarcinoma of Lung · France.
Among the 22 studies in Adenocarcinoma of Lung with a site in France, this one is the 9th largest by planned enrollment of the 16 interventional ones that give a count, is the only one that started in 2020, is one of 5 in phase 3, and was the 19th registered.
418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.
Browse Adenocarcinoma of Lung studies →1 of the 22 studies in Adenocarcinoma of Lung with a site in France is open now.
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 58 Adenocarcinoma of Lung studies recruiting now, 36 (62%) set no upper age limit and 10 (17%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 9 · Phase 3 6
First in 1994; this study’s year is marked. 1 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 214 is above the median of 60 across 293 interventional studies indexed under Adenocarcinoma of Lung.
Median enrollment 223 across the 16 interventional studies, 133 across the 4 observational. Of the 15 that completed or were terminated, 7 (47%) have results posted.
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11 of 22 have an industry lead sponsor. The 10 most frequent:
Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Institut Bergonié has 1 study filed under Adenocarcinoma of Lung — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Adenocarcinoma of Lung with a site in France, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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:
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.
Upon signature of the informed consent and verification of the screening results, eligible participants will be randomized between two therapeutic strategies:
Pembrolizumab treatment should begin no later than 7 days after randomization. The cryoablation treatment should be performed within 6 weeks after the first administration of pembrolizumab.
RECIST v1.1 tumour assessment:Tumour response will be defined and assessed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
SAFETY :Patients will be evaluable for safety if they have received at least one treatment administration. Safety profile will be continuously followed during treatment up to 90 days after the last immunotherapy treatment administration or until the start of a new antitumor therapy or until 12 months of treatment, whichever occurs first.
STUDY PROCEDURES :
Blood sample will be collected at baseline (Day 1: before treatment initiation), Day 1 cycle 2 (Day 21 +/- 3 days), Day 1 cycle 3 (Day 42 +/- 3 days) and progression.
Patients will be asked to provide samples of biopsy tissue at screening (prior to anticancer agent with immunomodulatory activity treatment initiation), during treatment (day 42 +/- 3 days) and at disease progression as follows. Tumor biopsy at inclusion is optional if materiel archived fixed in formalin and embedded in paraffin of diagnostic biopsy is available.
All randomized patients will be followed up until death or the end of the follow-up period, defined as 36 months after randomization, whichever occurs first. For all patients, treatments regimen, tumor response during and/or after treatment, survival follow-up will be collected on study database:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least two target lesions (RECIST1.1), measurable with CT or MRI :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Cryoablation · Drug: Pembrolizumab · Drug: Pemetrexed · Drug: Carboplatin
Combination of Pembrolizumab and pemetrexed-carboplatin prescribed as per market authorization.
Drug: Pembrolizumab · Drug: Pemetrexed · Drug: Carboplatin
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 will be prescribed and administered at the dose recommended by market authorization.
Pemetrexed will be prescribed and administered at the dose recommended by market authorization.
Carboplatin will be prescribed and administered at the dose recommended by market authorization.
1-year overall survival rate
Overall survival (OS) is defined as the time interval between the date of randomization and the date of death (from any cause). Patients alive will be censored at the date of last follow-up or last patient contact. One-year OS rates will be compared between arms.
Time frame: 1 year
Overall response rate within 6 months as per RECIST v1.1
Overall response rate (ORR) is defined as the rate of patients with complete or partial response (CR, PR) as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Overall Response (OR) = CR + PR.
Time frame: throughout the treatment period, an expected average of 6 months
Overall response rate at 6 months as per RECIST v1.1
Overall response rate (ORR) is defined as the rate of patients with complete or partial response (CR, PR) as per RECIST v1.1. According to RECIST v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Overall Response (OR) = CR + PR.
Time frame: 6 months
Overall response rate as per RECIST v1.1
Overall response rate (ORR) is defined as the rate of patients with complete or partial response (CR, PR) as per RECIST v1.1. ORR will be assessed across all time points, once all the data for the patient is known. According to RECIST v1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.; Overall Response (OR) = CR + PR.
Time frame: throughout the treatment period, an expected average of 1 year
Duration of overall response
The duration of overall response (DoR) is defined as the time from documentation of tumour response (Complete or partial responses whichever is first recorded) to disease progression, according to RECIST v1.1. Kaplan-Meier Method will be used to estimate DoR.
Time frame: throughout the treatment period, an expected average of 1 year
Best overall response rate as per RECIST v1.1
Best overall response rate (BoR) is defined as rate of patients with the best response across all time points (RECIST v1.1). The best overall response will be determined once all the data for the patient is known.
Time frame: throughout the treatment period, an expected average of 1 year
2-year overall survival rate
Overall survival (OS) is defined as the time interval between the date of randomization and the date of death (from any cause). 2-year OS rates will be compared between arms.
Time frame: 2 years
1-year progression-free survival rate
Progression-free survival (PFS) is defined as the time interval between the date of randomization and the date of progression (RECIST v1.1) or death (from any cause), whichever occurs first.The analysis of PFS will be based on the censoring process following FDA guidelines. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.1-year PFS rates will be compared between arms.
Time frame: 1 year
2-year progression-free survival rate
Progression-free survival (PFS) is defined as the time interval between the date of randomization and the date of progression (RECIST v1.1) or death (from any cause), whichever occurs first.The analysis of PFS will be based on the censoring process following FDA guidelines. Progression is defined using RECIST v1.1, as a 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), or a unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions.2-year PFS rates will be compared between arms.
Time frame: 2 years
Mean scores of each dimension of QLQ-C30 from EORTC quality of life group
Health-related quality of life (HRQoL) will be assessed through EORTC QLQ-C30 (Aaronson et al. J Natl Cancer Inst 1993).The QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. The questionnaire includes one global health status/QoL scale, five functional scales and three symptom scale. Each scale is scored from 0 to 100. A high score on a scale indicate a good outcome for the dimension of QoL.
Time frame: at baseline, 3, 6, 9, 12 and 24 months
Time to health-related quality of life score definitive deterioration (targeted dimension of EORTC QLQC30 : global health)
Time until definitive deterioration (TUDD) of HRQoL is defined as the time from the date of randomization to a first deterioration of at least 10 points of HRQoL as compared to the baseline score (Bonnetain et al. Eur J Cancer 2010).
Time frame: at baseline, 3, 6, 9, 12 and 24 months
Number of patient receiving a post-progression treatment
Post-progression treatment is defined as the treatment (systemic/local) given after the first progression under cryoablation+pembrolizumab and pemetrexed-carboplatin or pembrolizumab and pemetrexed-carboplatin.
Time frame: an average of 6 months
Overall response rate as per iRECIST
Overall response rate (ORR) is defined as the rate of patients with immune complete or partial responses (iCR, iPR) as per iRECIST (Seymour et al. 2017). iCR and iPR can be assigned after iUPD (immune unconfirmed progressive disease) has been documented.
Time frame: throughout the treatment period, an expected average of 6 months
Duration of immune overall response
Duration of i-response (iDoR) is defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of PD (iUPD confirmed as iCPD). iDOR is only defined for subjects who have best overall response of iCR or iPR.
Time frame: throughout the treatment period, an expected average of 1 year
1-year immune-progression-free survival rate
Immune-progression-free survival (iPFS) is defined as the time interval between the date of randomization and the date of progression (iRECIST) or death (from any cause), whichever occurs first. The event date to be used for calculation of progression-free survival (iPFS) should be the first date at which progression criteria are met (ie, the date of iUPD) provided that iCPD is confirmed at the next assessment. 1-year iPFS rates will be compared between arms.
Time frame: 1 year
2-year immune-progression-free survival rate
Immune-progression-free survival (iPFS) is defined as the time interval between the date of randomization and the date of progression (iRECIST) or death (from any cause), whichever occurs first. The event date to be used for calculation of progression-free survival (iPFS) should be the first date at which progression criteria are met (ie, the date of iUPD) provided that iCPD is confirmed at the next assessment. 2-year iPFS rates will be compared between arms.
Time frame: 2 year
Best overall response rate as per iRECIST
Best overall response rate (iBoR) is defined, according to iRECIST, as the rate of patients with the best timepoint response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation.
Time frame: throughout the treatment period, an expected average of 1 year
Number of immune-related SAEs (CTCAE NCI V5)
Serious Adverse events (SAEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of immune-related AEs (CTCAE NCI V5)
Adverse events (AEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of chemotherapy-related SAEs (CTCAE NCI V5)
Serious Adverse events (SAEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of chemotherapy-related AEs (CTCAE NCI V5)
Adverse events (AEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of cryoablation-related SAEs (CTCAE NCI V5)
Serious Adverse events (SAEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of cryoablation-related AEs (CTCAE NCI V5)
Adverse events (AEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of SAEs related to study procedures (CTCAE NCI V5)
Serious Adverse events (SAEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of AEs related to study procedures (CTCAE NCI V5)
Adverse events (AEs) will be coded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) NCI v5.
Time frame: throughout the treatment period, an expected average of 1 year
Number of hospitalisations in experimental arm only
counts of hospitalisations within 30 days after the cryoablation will be summarized by treatment strategy.
Time frame: within 6 weeks + 30 days after first pembrolizumab administration
Percentage of patients that worsen their ECOG score of 1 or more point
Percentage of patients that worsen their ECOG score of 1 or more point at follow-up visits post randomization will be summarized by treatment strategy.
Time frame: at follow-up visits post randomization (an average of 2 years)
Started Aug 2020 (actual). Primary completion is estimated for Aug 2026, 71 months after the start.
How these figures are worked out, and which studies are left out of them.
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