Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study

Recruiting now · Phase 3

Conditions studied: Metastatic Non-squamous Lung Cancer

In brief

Pulse is a randomized non-inferiority phase III clinical trial assessing a new mode of immunotherapy administration based on increased interval time between 2 infusions as maintenance treatment in Pulse arm compared with the conventional administration in Control arm. 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).

Key facts

Study ID

NCT05692999

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

1166

Starts

2023-03-20

Expected to finish

2029-01-01

Last updated by the study team

2025-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A) To be checked before the induction phase (only for patient included before induction phase) :
• Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
• Non-operable / non-irradiable stage III or stage IV.
• Patient must be eligible to receive 3 or 4 cycles of induction treatment combination with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.
• In the presence of an EGFR mutation, an ALK or ROS1 rearrangement the patient must have received at least one specific targeted therapy line.
• Age ≥ 18 years old.
• Performance status 0 or 1.
• Signed informed consent.
• Patient affiliated to a social security system or beneficiary of the same.
• B) To be checked before the maintenance phase (for all patient) :
• Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC).
• Non-operable / non-irradiable stage III or stage IV.
• Received 3 or 4 cycles of induction treatment combination with pembrolizumab plus platinum (cisplatin or carboplatin) and pemetrexed.
• Patient must be eligible to receive maintenance pembrolizumab with or without pemetrexed, last induction chemotherapy cycle within 42 days before randomization.
• Stable disease, partial or complete response according to RECIST 1.1 criteria after induction chemotherapy and pembrolizumab. Targets lesions are not required before randomization.
• 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).
• Patients with baseline brain metastases will be eligible in case of stability or no evidence of progression and if they remain clinically stable.
• Age ≥ 18 years old.
• Performance status 0 or 1.
• Signed informed consent (only for patient included after induction phase).
• Patient affiliated to a social security system or beneficiary of the same.
• 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.

You may not qualify if…

• A) To be checked before the induction phase (only for patient included before induction phase) :
• Mixed small-cell, squamous-cell carcinoma.
• Mental or psychological illness that does not allow the patient to give informed consent.
• Pregnant or breastfeeding women.
• History of HIV or chronic hepatitis B or C.
• Active or uncontrolled infection.
• 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
• Concomitant treatment with another experimental treatment or participation in another clinical trial.
• B) To be checked before the maintenance phase (for all patient) :
• Presence of grade 3 or 4 toxicity related to pembrolizumab limiting maintenance treatment continuation.
• Mixed small-cell, squamous-cell carcinoma.
• Corticosteroids at a dose greater than 20 mg per day of prednisone or equivalent.
• Patient unable to follow the therapeutic program.
• Mental or psychological illness that does not allow the patient to give informed consent.
• Pregnant or breastfeeding women.
• Ongoing immunosuppressive systemic therapy (cyclophosphamide, aziatropin, methotrexate, thalidomide and anti-TNF).
• 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.
• 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.
• 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.
• 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.

Where it is running

• H.Virgen del Rocio — Seville, Spain (enrolling)
• Centre Hospitalier de Carcassonne — Carcassonne, Aude, France (enrolling)
• Clinique Sainte Anne - Strasbourg — Strasbourg, Bas-Rhin, France (enrolling)
• Institut de Cancérologie Strasbourg Europe (ICANS) — Strasbourg, Bas-Rhin, France (enrolling)
• Hôpital Européen de Marseille — Marseille, Bouches-du-Rhône, France (enrolling)
• Groupe Hospitalier La Rochelle — La Rochelle, Charente-Maritime, France (enrolling)
• Centre Hospitalier Régional Universitaire de Brest (Hôpital Morvan) — Brest, Finistère, France (enrolling)
• Centre Hospitalier des Pays de Morlaix — Morlaix, Finistère, France (enrolling)
• Groupe Hospitalier de la Région de Mulhouse et Sud Alsace — Mulhouse, Haut-Rhin, France (enrolling)
• Centre Hospitalier de Bigorre — Tarbes, Hautes-Pyrénées, France (enrolling)
• Hôpital Foch — Suresnes, Hauts-de-Seine, France (enrolling)
• Centre Hospitalier de Béziers — Béziers, Hérault, France (enrolling)
• CHU Rennes — Rennes, Ille-et-Vilaine, France (enrolling)
• Centre Hospitalier de Saint-Malo — St-Malo, Ille-et-Vilaine, France (enrolling)
• Centre Hospitalier Régional Universitaire de Tours — Tours, Indre-et-Loire, France (enrolling)
• Hospital Virgen de la Victoria — Málaga, Spain (enrolling)
• CHU UCL Namur - Site Sainte Elisabeth — Namur, Belgium (enrolling)
• Centre Hospitalier Régional d'Orléans - NHO — Orléans, Loiret, France (enrolling)
• Hospices Civils de Lyon - Hôpital Louis Pradel — Bron, Lyon, France (enrolling)
• Centre Hospitalier de Cholet — Cholet, Maine-et-Loire, France (enrolling)
• Centre Hospitalier Intercommunal de Compiègne-Noyon — Compiègne, Oise, France (enrolling)
• CHU St-Etienne — Saint Priest En Jarez, Pays de la Loire Region, France (enrolling)
• Centre Hospitalier de la Côte Basque — Bayonne, Pyrénées-Atlantiques, France (enrolling)
• Centre Hospitalier Intercommunal Créteil — Créteil, Val-de-Marne, France (enrolling)
• Hôpital d'Instruction des Armées Bégin — Saint-Mandé, Val-de-Marne, France (enrolling)

Full record on ClinicalTrials.gov

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