RecruitingPhase 3NCT05692999

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

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

1,166 participants

Start Date

Mar 20, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Non-squamous Lung Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (PULSE) tests whether a lower dose of pembrolizumab — an immunotherapy drug — works just as well as the standard dose for maintaining remission in people with advanced non-squamous non-small cell lung cancer (NSCLC) that responded to initial treatment. **You may be eligible if...** - You are 18 or older - You have confirmed non-squamous non-small cell lung cancer that cannot be surgically removed (stage III or IV) - You received 3 to 4 cycles of induction chemotherapy combined with pembrolizumab (with platinum and pemetrexed) - Your cancer is stable or responding (did not progress) after that induction treatment - You are eligible to continue maintenance pembrolizumab - If your cancer has certain genetic mutations (EGFR, ALK, ROS1), you must have already received targeted therapy **You may NOT be eligible if...** - Your cancer progressed during or after induction chemotherapy - You are pregnant or unwilling to use contraception - You have serious autoimmune disease or significant organ dysfunction - You have not completed the required induction chemotherapy cycles Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab 200 mg Q6W

Pembrolizumab 200mg Q6W

DRUGPemetrexed 500 mg/m^2 Q3W

Pemetrexed 500 mg/m\^2 Q3W

DRUGPembrolizumab 200 mg Q3W or 400 mg Q6W

Pembrolizumab 200 mg Q3W or 400 mg Q6W

Locations(37)

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

View Full Details on ClinicalTrials.gov

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NCT05692999