Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study
NCT ID: NCT05692999
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1166 participants
INTERVENTIONAL
2023-03-20
2029-01-31
Brief Summary
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In both treatment arms, pembrolizumab alone or combined with pemetrexed is allowed as maintenance treatment. Indeed :
In Pulse arm : Pembrolizumab 200 mg will be administered to patients every 6 weeks (Q6W) plus, in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W).
In control arm : Pembrolizumab 200 mg will be administered to patients every 3 weeks (Q3W) or 400 mg every 6 weeks plus,in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pulse Arm
Pembrolizumab 200 mg Q6W
Pembrolizumab 200mg Q6W
Pemetrexed 500 mg/m^2 Q3W
Pemetrexed 500 mg/m\^2 Q3W
Control Arm
Pemetrexed 500 mg/m^2 Q3W
Pemetrexed 500 mg/m\^2 Q3W
Pembrolizumab 200 mg Q3W or 400 mg Q6W
Pembrolizumab 200 mg Q3W or 400 mg Q6W
Interventions
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Pembrolizumab 200 mg Q6W
Pembrolizumab 200mg Q6W
Pemetrexed 500 mg/m^2 Q3W
Pemetrexed 500 mg/m\^2 Q3W
Pembrolizumab 200 mg Q3W or 400 mg Q6W
Pembrolizumab 200 mg Q3W or 400 mg Q6W
Eligibility Criteria
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Inclusion Criteria
1. Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
2. Non-operable / non-irradiable stage III or stage IV.
3. Patient must be eligible to receive 3 or 4 cycles of induction treatment combination with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.
4. In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line.
5. Age ≥ 18 years old.
6. Performance status 0 or 1.
7. Signed informed consent.
8. Patient affiliated to a social security system or beneficiary of the same.
B) To be checked before the maintenance phase (for all patient) :
1. Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
2. Non-operable / non-irradiable stage III or stage IV.
3. Received 3 or 4 cycles of induction treatment combination with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.
4. Patient must be eligible to receive maintenance pembrolizumab with or without pemetrexed, last induction chemotherapy cycle within 42 days before randomization.
5. Stable disease, partial or complete response according to RECIST 1.1 criteria after induction chemotherapy and pembrolizumab. Targets lesions are not required before randomization.
6. In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line (not needed a second time if already checked before induction phase).
7. Patients with baseline brain metastases will be eligible in case of stability or no evidence of progression and if they remain clinically stable.
8. Age ≥ 18 years old.
9. Performance status 0 or 1.
10. Signed informed consent (only for patient included after induction phase).
11. Patient affiliated to a social security system or beneficiary of the same.
12. Creatinine clearance \> 30 ml/min by Cockcroft-Gault\* or MDRD in case that patient will start maintenance just with pembrolizumab but ≥ 45 ml/min if the patient will receive pemetrexed plus pembrolizumab.
\*Cockcroft- Gault Formula:
* Female CrCl = \[(140 - age in years) x weight in kg x 0.85\] / 72 x serum creatinine in mg/dL;
* Male CrCl = \[(140 - age in years) x weight in kg x 1.00\] /72 x serum creatinine in mg/dL.
13. Neutrophils ≥ 1500/μL and platelets ≥ 100 000/μL.
14. Bilirubin ≤ 1.5 upper limit normal (ULN).
15. Transaminases, Alkaline phosphatase ≤ 2.5 x the ULN except in case of liver metastases (5 x ULN).
16. Patients might have received platinum-based chemotherapy as an adjuvant or neoadjuvant treatment, or with radiotherapy for a localized lung cancer, provided that the chemotherapy was ended more than 6 months before the first cycle of induction chemotherapy.
17. Patients might have received previous immune checkpoint inhibitors as an adjuvant or neoadjuvant treatment, or as a consolidation treatment after radiotherapy for a localized lung cancer, but the immune checkpoint inhibitors must be finished at least than 12 months before the first cycle of induction chemotherapy for advanced stage.
18. A woman is eligible for the study if she is no longer likely to procreate (physiologically unfit to carry out a pregnancy), which includes women who have had: a hysterectomy, an oophorectomy, a bilateral tubal ligation.
Post-menopausal women:
* Patients not using hormone replacement therapy should have had a complete cessation of menstruation for at least one year and be over 40 years of age, or, if in doubt, have an FSH (Follicle Stimulating Hormone) level \> 40 mIU/mL and an estradiol level \< 40 pg/mL (\< 150 pmol/L).
* Patients using hormone replacement therapy must have had a complete cessation of menstruation for at least one year and be over 45 years of age or have evidence of menopause (FSH and estradiol levels) before starting hormone replacement therapy.
19. Women who are likely to procreate are eligible if they have a negative serum pregnancy test in the week before the first dose of treatment and preferably as close as possible to the first dose and if they agree to use an effective contraceptive method during the course of the study through 4 months after the last dose of study medication.
Sexually active males patients must agree to use condom during the study and for at least 4 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
Exclusion Criteria
1. Mixed small-cell, squamous-cell carcinoma.
2. Mental or psychological illness that does not allow the patient to give informed consent.
3. Pregnant or breastfeeding women.
4. History of HIV or chronic hepatitis B or C.
5. Active or uncontrolled infection.
6. History of one or more of the following cardiovascular disorders in the previous 6 months:
* Coronary artery bypass or peripheral arterial bypass, cardiac angioplasty or stent.
* Myocardial infarction
* Severe or unstable angina pectoris
* Peripheral vascular disease, pulmonary embolism or untreated thromboembolic events, stroke or transient ischemic attack. Note: Patients with recent deep vein thrombosis (including pulmonary embolism) treated with anticoagulant for at least 4 weeks and clinically stable are eligible.
* Congestive heart failure class III or IV as defined by the NYHA
7. Concomitant treatment with another experimental treatment or participation in another clinical trial.
B) To be checked before the maintenance phase (for all patient) :
1. Presence of grade 3 or 4 toxicity related to pembrolizumab limiting maintenance treatment continuation.
2. Mixed small-cell, squamous-cell carcinoma.
3. Corticosteroids at a dose greater than 20 mg per day of prednisone or equivalent.
4. Patient unable to follow the therapeutic program.
5. Mental or psychological illness that does not allow the patient to give informed consent.
6. Pregnant or breastfeeding women.
7. Ongoing immunosuppressive systemic therapy (cyclophosphamide, aziatropin, methotrexate, thalidomide and anti-TNF).
8. Active autoimmune diseases. History of autoimmune diseases including myasthenia gravis, lupus erythematosus, rheumatoid arthritis, irritable bowel syndrome, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. Patients with a history of autoimmune hypothyroidism treated with a stable dose of hormone replacement therapy are eligible. Patients with diabetes treated with insulin are eligible.
9. History of idiopathic pulmonary fibrosis, organized pneumonia (i.e., obliterating bronchiolitis), drug-induced lung disease or active signs of pneumonia, pulmonary infiltration (regardless of cause) detected on the baseline chest CT-scan.
10. History of any other hematologic or primary solid tumor malignancy unless in remission for at least 2 years and without specific treatment (as example, not allowed hormonal therapy to replace for breast cancer or hormonal therapy substitution in prostate cancer). pT1-2 prostatic cancer Gleason score \< 6, superficial bladder cancer, non-melanoma skin cancer or carcinoma in situ of the cervix are allowed.
11. Presence of a condition or condition that makes patient participation in the study inappropriate, including serious unresolved or unstable toxicities from previous administration of another experimental treatment or any medical condition that could interfere with patient safety, obtaining consent or compliance with study procedures.
12. Administration of a live attenuated vaccine within the 4 weeks before day 1 of Cycle 1 or administration of a live attenuated vaccine planned for the duration of the study. The flu vaccine can be given during the flu season (approximately from October to May). Patients should not receive a live attenuated influenza vaccine during the 4 weeks preceding day 1 of Cycle 1 and should not receive this type of vaccine during the study.
13. History of HIV or chronic hepatitis B or C (not needed a second time if already checked before induction phase).
14. Active or uncontrolled infection.
15. History of one or more of the following cardiovascular disorders in the previous 6 months:
* Coronary artery bypass or peripheral arterial bypass, cardiac angioplasty or stent.
* Myocardial infarction
* Severe or unstable angina pectoris
* Peripheral vascular disease, pulmonary embolism or untreated thromboembolic events, stroke or transient ischemic attack. Note: Patients with recent deep vein thrombosis (including pulmonary embolism) treated with anticoagulant for at least 4 weeks and clinically stable are eligible.
* Congestive heart failure class III or IV as defined by the NYHA
16. Concomitant treatment with another experimental treatment or participation in another clinical trial.
18 Years
ALL
No
Sponsors
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Gustave Roussy, Cancer Campus, Grand Paris
OTHER
Responsible Party
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Principal Investigators
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Benjamin BESSE
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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CHU UCL Namur - Site Sainte Elisabeth
Namur, , Belgium
Centre Hospitalier de Carcassonne
Carcassonne, Aude, France
Clinique Sainte Anne - Strasbourg
Strasbourg, Bas-Rhin, France
Institut de Cancérologie Strasbourg Europe (ICANS)
Strasbourg, Bas-Rhin, France
Hôpital Européen de Marseille
Marseille, Bouches-du-Rhône, France
Groupe Hospitalier La Rochelle
La Rochelle, Charente-Maritime, France
Centre Hospitalier Régional Universitaire de Brest (Hôpital Morvan)
Brest, Finistère, France
Centre Hospitalier des Pays de Morlaix
Morlaix, Finistère, France
Groupe Hospitalier de la Région de Mulhouse et Sud Alsace
Mulhouse, Haut-Rhin, France
Centre Hospitalier de Bigorre
Tarbes, Hautes-Pyrénées, France
Hôpital Foch
Suresnes, Hauts-de-Seine, France
Centre Hospitalier de Béziers
Béziers, Hérault, France
CHU Rennes
Rennes, Ille-et-Vilaine, France
Centre Hospitalier de Saint-Malo
St-Malo, Ille-et-Vilaine, France
Centre Hospitalier Régional Universitaire de Tours
Tours, Indre-et-Loire, France
Centre Hospitalier Universitaire - La Réunion - Site Felix Guyon
Saint-Denis, La Réunion, France
Centre Hospitalier Universitaire - La Réunion - Site Sud
Saint-Pierre, La Réunion, France
Centre Hospitalier Régional d'Orléans - NHO
Orléans, Loiret, France
Hospices Civils de Lyon - Hôpital Louis Pradel
Bron, Lyon, France
Centre Hospitalier de Cholet
Cholet, Maine-et-Loire, France
Centre Hospitalier Intercommunal de Compiègne-Noyon
Compiègne, Oise, France
CHU St-Etienne
Saint Priest En Jarez, Pays de la Loire Region, France
Centre Hospitalier de la Côte Basque
Bayonne, Pyrénées-Atlantiques, France
Centre Hospitalier Intercommunal Créteil
Créteil, Val-de-Marne, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé, Val-de-Marne, France
Institut Gustave Roussy
Villejuif, Val-de-Marne, France
Centre Hospitalier d'Auxerre
Auxerre, Yonne, France
Hôpital Pitié-Salpêtrière - APHP
Paris, , France
Hôpital Cochin - APHP
Paris, , France
Hôpital Tenon - APHP
Paris, , France
Hôpital Paris Saint-Joseph
Paris, , France
H. Santa Creu i Sant Pau
Barcelona, , Spain
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, , Spain
H. Clinico San Carlos
Madrid, , Spain
HU. 12 de Octubre
Madrid, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
H.Virgen del Rocio
Seville, , Spain
Countries
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Central Contacts
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Facility Contacts
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Vincent VAHHAUDENARDE, MD
Role: primary
LABOUREY Jean Luc, MD
Role: primary
TAZI Youssef, MD
Role: primary
SCHOTT Rolland, MD
Role: primary
LE TREUT Jacques, md
Role: primary
LEVRAT Virginie, MD
Role: primary
QUERE Gilles, MD
Role: primary
AMRANE Karim, MD
Role: primary
DEBIEUVRE Dédier, MD
Role: primary
DEGUIRAL Philippe, MD
Role: primary
METIVIER Anne Cécile, MD
Role: primary
HAOUACHI Rym, MD
Role: primary
RICORDEL Charles, MD
Role: primary
TIERCIN Marie, MD
Role: primary
CARMIER Delphine, MD
Role: primary
GAZAILLE Virgile, MD
Role: primary
HUCHOT Eric, MD
Role: primary
DIXMIER Adrien, MD
Role: primary
DURUISSEAUX Michaël, MD
Role: primary
GUILLEMOIS Sylvère, MD
Role: primary
DEHETTE Stéphanie, MD
Role: primary
FOURNEL Pierre, MD
Role: primary
SCHNEIDER Sophie, MD
Role: primary
MONNET Isabelle, MD
Role: primary
HELISSEY Carole, MD
Role: primary
MARTI Adina, MD
Role: primary
SPANO Jean-Philippe, MD
Role: primary
WISLEZ Marie, MD
Role: primary
CADRANEL Jacques, MD
Role: primary
NALTET Charles, MD
Role: primary
Andrés BARBA JOAQUIN, MD
Role: primary
Nuria PARDO ARANDA, MD
Role: primary
Carlos AGUADO DE LA ROSA, MD
Role: primary
Jon Zugazagoitia, MD
Role: primary
José Carlos Benítez Montañez, MD
Role: primary
Reyes BERNABE CARO, MD
Role: primary
Other Identifiers
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2021/3336
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503481-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
2021-006795-16
Identifier Type: -
Identifier Source: org_study_id
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