Informations générales (source: ClinicalTrials.gov)
Randomized, Open-label, Controlled Phase III Trial Comparing Pembrolizumab-platinum Based Chemotherapy Combination With Pembrolizumab Monotherapy in First Line Treatment of Non-small-cell Lung Cancers (NSCLC) With PDL1 Expression ≥50% (PERSEE)
Interventional
Phase 3
University Hospital, Brest (Voir sur ClinicalTrials)
décembre 2020
décembre 2025
10 août 2024
PERSEE is a French national phase 3 academic study comparing the
chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment
for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no
EGFR mutations or ALK rearrangement.
The main hypothesis is the superiority of the chemo-immunotherapy combination over
mono-immunotherapy in terms of progression-free survival evaluated by an independent
review committee.
One of the anticipated benefits of using the chemotherapy-pembrolizumab combination
starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced
risk of early progression, which is known to occur with pembrolizumab monotherapy, and
therefore, a better PFS.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Jean Bernard AULIAC | 29/03/2024 01:29:34 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 19/02/2024 08:52:21 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de lutte contre le cancer - Centre François Baclesse - 14000 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Cornouaille - 29000 - Quimper - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Métropole Savoie - 73000 - Chambéry - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Berard - 69008 - Lyon - France | Contact (sur clinicalTrials) | ||||
| CH d'Annecy-genevois - 74374 - Pringy - France | Contact (sur clinicalTrials) | ||||
| CH de Lorient - Hôpital du Scorff - 56100 - Lorient - France | Contact (sur clinicalTrials) | ||||
| CH du Pays d'Aix - 13616 - Aix-en-Provence - France | Contact (sur clinicalTrials) | ||||
| CH La Réunion - Site Félix Guyon - 97400 - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
| CH La Roche Sur Yon - CHD Les Oudairies - 85000 - Roche Sur Yon - France | Contact (sur clinicalTrials) | ||||
| Ch Villefranche Sur Saone - 69655 - Villefranche-sur-Saône - France | Contact (sur clinicalTrials) | ||||
| CHRU de Brest - 29609 - Brest - France | Contact (sur clinicalTrials) | ||||
| CHU AMIENS - Hôpital Sud - 80054 - Amiens - France | Contact (sur clinicalTrials) | ||||
| Chu Angers - 49033 - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU Bordeaux - Hôpital du Haut Levêque - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Chu Dupuytren - 87042 - Limoges - France | Contact (sur clinicalTrials) | ||||
| CHU La Réunion - Groupe Hospitalier Sud - 97410 - Saint-Pierre - France | Contact (sur clinicalTrials) | ||||
| CHU MARSEILLE_ Hopital Nord - 13915 - Marseille - France | Contact (sur clinicalTrials) | ||||
| CHU RENNES - Hôpital Pontchailloux - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU ROUEN - Hôpital Charles Nicolle - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hôpital d'Instruction des Armées Toulon - Saint Anne - 83041 - Toulon - France | Contact (sur clinicalTrials) | ||||
| Hôpital Européen Marseille - 13003 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie Strasbourg Europe - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmette - 13000 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Saint Aubin Les Elbeuf - 76503 - Saint-Aubin-lès-Elbeuf - France | Contact (sur clinicalTrials) | ||||
| SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire - 42271 - Saint-Priest-en-Jarez - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age 18 years or older at diagnosis.
2. Histologically or cytologically confirmed NSCLC.
3. Stage IV NSCLC. Unresectable and non-eligible to radiotherapy stage III NSCLC are
permitted.
4. For non-squamous NSCLCs and non-smoking squamous NSCLCs, no known activating
mutations of EGFR and no ALK or ROS-1 rearrangements.
5. PD-L1 expression on ≥ 50 % of tumor cells, which will be determined locally.
6. No prior systemic treatment for lung cancer. Patients who received adjuvant therapy
are eligible if the adjuvant therapy was completed at least 12 months prior to the
development of metastatic disease.
7. Palliative radiotherapy completed within one day before randomization (stereotaxic
or not) is authorized.
8. At least 1 target lesion in a non-irradiated area, measurable according to RECIST
v1.1.
9. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
10. Life expectancy >12 weeks.
11. Patients with brain metastases at inclusion are accepted, provided that these
metastases are asymptomatic, or symptomatic but treated (surgery or radiotherapy
without or with corticosteroids ≤10 mg/day), and that they are stable on the day of
inclusion.
12. No history of other malignant tumor during the previous 5 years, except for
adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma,
squamous cell skin carcinoma) and low grade localized prostate cancer (Gleason <6).
13. Adequate organ function, as demonstrated by laboratory results within 7 days prior
to the first administration of study treatment:
1. Normal hepatic function: bilirubin ≤1.5 x upper limit of normal (ULN), alanine
aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≤2.5 x ULN or ≤5
x ULN in case of liver metastases
2. Normal renal function: calculated creatinine clearance (CrCl, using local
formula) of at least 60 mL/min for cisplatin or 45 ml/mn for carboplatin
3. Normal hematological function: absolute neutrophil count ≥1.5 giga/L and/or
platelets ≥100 giga/L, hemoglobin ≥8 g/dL
4. Normal coagulation function: International Normalized Ratio (INR) or
prothrombin time ≤1.5 x ULN and activated partial thromboplastin time (aPTT)
≤1.5 x ULN unless the patient is receiving anticoagulant therapy.
14. For patients of childbearing potential: use of an adequate method of contraception
during the course of the study through 180 days after the last dose of study
treatment (women of childbearing potential must have a negative serum or urine
pregnancy test within 7 days prior to the first administration of study treatment).
Note: Abstinence is acceptable if this is the usual lifestyle and the patient's
preferred contraception. For male subjects, male condom or abstinence are
acceptable.
15. Signed informed consent to participate in the study
16. Affiliation with or benefit from French social security.
Exclusion criteria :
1. NSCLC with expression of PD-L1 <50%.
2. NSCLC with known activating mutation of EGFR or ALK or ROS-1 translocation.
3. Neuroendocrine tumor. In cases of mixed tumors, if small cell elements are present,
the patient is ineligible.
4. Any previous treatment with immunotherapy regardless of the line of treatment.
5. Before the first dose of study treatment:
1. Has received prior systemic treatment for metastatic disease (chemotherapy or
targeted therapy).
2. Had major surgery <3 weeks prior to first dose.
3. Received radiation therapy to the lung that is >30 Gy within 6 months of the
first dose of study treatment.
6. Uncontrolled and untreated superior cava syndrome.
7. Untreated and unstable symptomatic brain metastases.
8. Leptomeningeal disease.
9. Serious concurrent conditions during the previous 6 months (severe or unstable
angina pectoris, coronary or peripheral artery bypass graft of <6 months, class 3 or
4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy,
psychiatric or neurological disorders that may interfere with the patient's
understanding of the study or with his/her informed consent.
10. Severe or non controlled systemic diseases deemed incompatible with the protocol.
11. Severe infections within 4 weeks prior to inclusion, including, but not limited to,
hospitalization for complications of infection, bacteremia, or severe pneumonia.
12. Other previous or concomitant cancers, with the exception of basal cell carcinoma,
squamous cell skin carcinoma, in situ cervical carcinoma treated, and low grade
localized prostate cancer (Gleason score <6) if appropriately treated, unless the
initial tumor has been diagnosed and definitively treated >5 years prior to the
study, with no signs of relapse.
13. Psychological, family, social, or geographical factors that may interfere with the
monitoring of the patient as defined by the protocol.
14. Any protected person (legal person protected by legal protection [guardianship,
tutorship], person deprived of liberty, pregnant woman, breastfeeding woman, and
minor).
15. Patients who participated in other concomitant studies unless observational and
received study therapy or used an investigational device within 4 weeks prior to
start of study treatment.
16. Known or suspected active autoimmune disease requiring an immunosuppressive therapy
during the previous 6 months (corticosteroids or other immunosuppressive treatment).
Any hormone replacement therapy (i.e. thyroxine [T4], insulin, or replacement
systemic corticosteroids for adrenal or pituitary insufficiency, etc.) is not
considered an immunosuppressive treatment and is authorized. Patients with
hyperthyroidism or hypothyroidism who are stable under hormone replacement therapy
may also be included.
17. Chronic use of immunosuppressive drugs and/or corticosteroids (>10 mg of prednisone
daily). However, during the 14 days prior to randomization the use of the following
is authorized:
1. Corticosteroids as pre treatment for the administration of chemotherapy and/or
for allergies or type IV hypersensitivity responses
2. Daily prednisone (≤10 mg) as replacement therapy
3. Inhaled or topical steroids.
18. Live-virus vaccination within 30 days of planned start of study treatment (seasonal
flu vaccines that do not contain live virus are permitted).
19. Previous allogenic tissue or organ transplant.
20. History of human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody
test results).
21. Active hepatitis B or C.
22. Previous history of interstitial lung disease (ILD) or non infectious pneumonia
(other than chronic obstructive pulmonary disease [COPD]), requiring oral or
systemic steroids, current pneumonia, or anticipated ILD.
23. Known allergies or adverse reactions to the study drugs or hypersensitivity reaction
to treatment with another monoclonal antibody (mAb).
1. Age 18 years or older at diagnosis.
2. Histologically or cytologically confirmed NSCLC.
3. Stage IV NSCLC. Unresectable and non-eligible to radiotherapy stage III NSCLC are
permitted.
4. For non-squamous NSCLCs and non-smoking squamous NSCLCs, no known activating
mutations of EGFR and no ALK or ROS-1 rearrangements.
5. PD-L1 expression on ≥ 50 % of tumor cells, which will be determined locally.
6. No prior systemic treatment for lung cancer. Patients who received adjuvant therapy
are eligible if the adjuvant therapy was completed at least 12 months prior to the
development of metastatic disease.
7. Palliative radiotherapy completed within one day before randomization (stereotaxic
or not) is authorized.
8. At least 1 target lesion in a non-irradiated area, measurable according to RECIST
v1.1.
9. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
10. Life expectancy >12 weeks.
11. Patients with brain metastases at inclusion are accepted, provided that these
metastases are asymptomatic, or symptomatic but treated (surgery or radiotherapy
without or with corticosteroids ≤10 mg/day), and that they are stable on the day of
inclusion.
12. No history of other malignant tumor during the previous 5 years, except for
adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma,
squamous cell skin carcinoma) and low grade localized prostate cancer (Gleason <6).
13. Adequate organ function, as demonstrated by laboratory results within 7 days prior
to the first administration of study treatment:
1. Normal hepatic function: bilirubin ≤1.5 x upper limit of normal (ULN), alanine
aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≤2.5 x ULN or ≤5
x ULN in case of liver metastases
2. Normal renal function: calculated creatinine clearance (CrCl, using local
formula) of at least 60 mL/min for cisplatin or 45 ml/mn for carboplatin
3. Normal hematological function: absolute neutrophil count ≥1.5 giga/L and/or
platelets ≥100 giga/L, hemoglobin ≥8 g/dL
4. Normal coagulation function: International Normalized Ratio (INR) or
prothrombin time ≤1.5 x ULN and activated partial thromboplastin time (aPTT)
≤1.5 x ULN unless the patient is receiving anticoagulant therapy.
14. For patients of childbearing potential: use of an adequate method of contraception
during the course of the study through 180 days after the last dose of study
treatment (women of childbearing potential must have a negative serum or urine
pregnancy test within 7 days prior to the first administration of study treatment).
Note: Abstinence is acceptable if this is the usual lifestyle and the patient's
preferred contraception. For male subjects, male condom or abstinence are
acceptable.
15. Signed informed consent to participate in the study
16. Affiliation with or benefit from French social security.
Exclusion criteria :
1. NSCLC with expression of PD-L1 <50%.
2. NSCLC with known activating mutation of EGFR or ALK or ROS-1 translocation.
3. Neuroendocrine tumor. In cases of mixed tumors, if small cell elements are present,
the patient is ineligible.
4. Any previous treatment with immunotherapy regardless of the line of treatment.
5. Before the first dose of study treatment:
1. Has received prior systemic treatment for metastatic disease (chemotherapy or
targeted therapy).
2. Had major surgery <3 weeks prior to first dose.
3. Received radiation therapy to the lung that is >30 Gy within 6 months of the
first dose of study treatment.
6. Uncontrolled and untreated superior cava syndrome.
7. Untreated and unstable symptomatic brain metastases.
8. Leptomeningeal disease.
9. Serious concurrent conditions during the previous 6 months (severe or unstable
angina pectoris, coronary or peripheral artery bypass graft of <6 months, class 3 or
4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy,
psychiatric or neurological disorders that may interfere with the patient's
understanding of the study or with his/her informed consent.
10. Severe or non controlled systemic diseases deemed incompatible with the protocol.
11. Severe infections within 4 weeks prior to inclusion, including, but not limited to,
hospitalization for complications of infection, bacteremia, or severe pneumonia.
12. Other previous or concomitant cancers, with the exception of basal cell carcinoma,
squamous cell skin carcinoma, in situ cervical carcinoma treated, and low grade
localized prostate cancer (Gleason score <6) if appropriately treated, unless the
initial tumor has been diagnosed and definitively treated >5 years prior to the
study, with no signs of relapse.
13. Psychological, family, social, or geographical factors that may interfere with the
monitoring of the patient as defined by the protocol.
14. Any protected person (legal person protected by legal protection [guardianship,
tutorship], person deprived of liberty, pregnant woman, breastfeeding woman, and
minor).
15. Patients who participated in other concomitant studies unless observational and
received study therapy or used an investigational device within 4 weeks prior to
start of study treatment.
16. Known or suspected active autoimmune disease requiring an immunosuppressive therapy
during the previous 6 months (corticosteroids or other immunosuppressive treatment).
Any hormone replacement therapy (i.e. thyroxine [T4], insulin, or replacement
systemic corticosteroids for adrenal or pituitary insufficiency, etc.) is not
considered an immunosuppressive treatment and is authorized. Patients with
hyperthyroidism or hypothyroidism who are stable under hormone replacement therapy
may also be included.
17. Chronic use of immunosuppressive drugs and/or corticosteroids (>10 mg of prednisone
daily). However, during the 14 days prior to randomization the use of the following
is authorized:
1. Corticosteroids as pre treatment for the administration of chemotherapy and/or
for allergies or type IV hypersensitivity responses
2. Daily prednisone (≤10 mg) as replacement therapy
3. Inhaled or topical steroids.
18. Live-virus vaccination within 30 days of planned start of study treatment (seasonal
flu vaccines that do not contain live virus are permitted).
19. Previous allogenic tissue or organ transplant.
20. History of human immunodeficiency virus (HIV) infection (positive HIV1/2 antibody
test results).
21. Active hepatitis B or C.
22. Previous history of interstitial lung disease (ILD) or non infectious pneumonia
(other than chronic obstructive pulmonary disease [COPD]), requiring oral or
systemic steroids, current pneumonia, or anticipated ILD.
23. Known allergies or adverse reactions to the study drugs or hypersensitivity reaction
to treatment with another monoclonal antibody (mAb).