AzTrials
AzTrials

Metastatic Non-squamous Lung CancerPhase 3PulseNCT05692999

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

A Phase 3 study testing Pembrolizumab 200 mg Q6W, Pemetrexed 500 mg/m^2 Q3W and Pembrolizumab 200 mg Q3W or 400 mg Q6W in people with Metastatic Non-squamous Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 37 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Non-squamous Lung Cancer
What is being tested?
Pembrolizumab 200 mg Q6W, Pemetrexed 500 mg/m^2 Q3W and Pembrolizumab 200 mg Q3W or 400 mg Q6W
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,166 participants
Where
37 sitesin 3 countries
Study dates
20 Mar 2023to Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 36Show fewer
  • Performance status 0 or 1.
  • Signed informed consent.
  • Patient affiliated to a social security system or beneficiary of the same.
  • 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.
  • Neutrophils ≥ 1500/μL and platelets ≥ 100 000/μL.
  • Bilirubin ≤ 1.5 upper limit normal (ULN).
  • Transaminases, Alkaline phosphatase ≤ 2.5 x the ULN except in case of liver metastases (5 x ULN).
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
Show all 35Show fewer
  • 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.
  • 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.
  • 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.
  • History of HIV or chronic hepatitis B or C (not needed a second time if already checked before induction phase).
  • 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.

Trial locations and contacts

37 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Benjamin BESSE contact

+33(0)1 42 11 62 61

Benjamin.BESSE@gustaveroussy.fr

Lynda MATI contact

+33(0)1 42 11 37 30

lynda.mati@gustaveroussy.fr

37 sites in 3 countries

France30 sites, 30 recruiting

  • Centre Hospitalier d'Auxerre

    Auxerre, Yonne, 89000

    MARTI Adina, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, Pyrénées-Atlantiques, 64100

    SCHNEIDER Sophie, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier de Béziers

    Béziers, Hérault, 34500

    HAOUACHI Rym, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Régional Universitaire de Brest (Hôpital Morvan)

    Brest, Finistère, 29609

    QUERE Gilles, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hospices Civils de Lyon - Hôpital Louis Pradel

    Bron, Lyon, 69677

    DURUISSEAUX Michaël, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier de Carcassonne

    Carcassonne, Aude, 11810

    LABOUREY Jean Luc, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier de Cholet

    Cholet, Maine-et-Loire, 49300

    GUILLEMOIS Sylvère, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Intercommunal de Compiègne-Noyon

    Compiègne, Oise, 60200

    DEHETTE Stéphanie, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Intercommunal Créteil

    Créteil, Val-de-Marne, 94010

    MONNET Isabelle, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Groupe Hospitalier La Rochelle

    La Rochelle, Charente-Maritime, 17000

    LEVRAT Virginie, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Européen de Marseille

    Marseille, Bouches-du-Rhône, 13003

    LE TREUT Jacques, md

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, Finistère, 29600

    AMRANE Karim, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Groupe Hospitalier de la Région de Mulhouse et Sud Alsace

    Mulhouse, Haut-Rhin, 68100

    DEBIEUVRE Dédier, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Régional d'Orléans - NHO

    Orléans, Loiret, 45067

    DIXMIER Adrien, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Pitié-Salpêtrière - APHP

    Paris, 75013

    SPANO Jean-Philippe, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Cochin - APHP

    Paris, 75014

    WISLEZ Marie, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Tenon - APHP

    Paris, 75020

    CADRANEL Jacques, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Paris Saint-Joseph

    Paris, 75674

    NALTET Charles, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • CHU Rennes

    Rennes, Ille-et-Vilaine, 35000

    RICORDEL Charles, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • CHU St-Etienne

    Saint Priest En Jarez, Pays de la Loire Region, 42270

    FOURNEL Pierre, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Universitaire - La Réunion - Site Felix Guyon

    Saint-Denis, La Réunion, 97400

    GAZAILLE Virgile, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Not yet recruiting

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, Val-de-Marne, 94160

    HELISSEY Carole, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Universitaire - La Réunion - Site Sud

    Saint-Pierre, La Réunion, 97448

    HUCHOT Eric, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Not yet recruiting

  • Centre Hospitalier de Saint-Malo

    St-Malo, Ille-et-Vilaine, 35400

    TIERCIN Marie, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Clinique Sainte Anne - Strasbourg

    Strasbourg, Bas-Rhin, 67000

    TAZI Youssef, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Institut de Cancérologie Strasbourg Europe (ICANS)

    Strasbourg, Bas-Rhin, 67200

    SCHOTT Rolland, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hôpital Foch

    Suresnes, Hauts-de-Seine, 92150

    METIVIER Anne Cécile, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier de Bigorre

    Tarbes, Hautes-Pyrénées, 65000

    DEGUIRAL Philippe, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, Indre-et-Loire, 37044

    CARMIER Delphine, MD

    Lynda MATI, 0142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Institut Gustave Roussy

    Villejuif, Val-de-Marne, 94 805

    Benjamin BESSE, +33 (0)1 42 11 62 61, Benjamin.BESSE@gustaveroussy.fr

    Recruiting

Other trials in France

Spain6 sites, 6 recruiting

  • H. Santa Creu i Sant Pau

    Barcelona, 08025

    Andrés BARBA JOAQUIN, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

    Nuria PARDO ARANDA, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • H. Clinico San Carlos

    Madrid, 28040

    Carlos AGUADO DE LA ROSA, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • HU. 12 de Octubre

    Madrid, 28041

    Jon Zugazagoitia, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • Hospital Virgen de la Victoria

    Málaga, 29010

    José Carlos Benítez Montañez, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

  • H.Virgen del Rocio

    Seville, 41013

    Reyes BERNABE CARO, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • CHU UCL Namur - Site Sainte Elisabeth

    Namur, B-5000

    Vincent VAHHAUDENARDE, MD

    Lynda MATI, 0033 142113730, lynda.mati@gustaveroussy.fr

    Recruiting

Other trials in Belgium

About this study

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 :

Read more

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).

Being tested
Pembrolizumab 200 mg Q6W, Pemetrexed 500 mg/m^2 Q3W, Pembrolizumab 200 mg Q3W or 400 mg Q6W

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 200 mg Q6WDrug

    Pembrolizumab 200mg Q6W

  • Pemetrexed 500 mg/m^2 Q3WDrug

    Pemetrexed 500 mg/m^2 Q3W

  • Pembrolizumab 200 mg Q3W or 400 mg Q6WDrug

    Pembrolizumab 200 mg Q3W or 400 mg Q6W

Study groups in NCT05692999
Study groupRoleWhat they receive
Pulse ArmExperimentalNot described
Receives: Drug: Pembrolizumab 200 mg Q6W; Drug: Pemetrexed 500 mg/m^2 Q3W
Control ArmActive comparatorNot described
Receives: Drug: Pemetrexed 500 mg/m^2 Q3W; Drug: Pembrolizumab 200 mg Q3W or 400 mg Q6W

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    defined as the time elapsed between the date of randomization and the date of death whatever the cause. Patients alive at the date of last follow-up will be censored at that date.

    Measured: 6 years

Secondary outcomes (11)

  1. Progression-free survival

    defined by the time between the randomization date and the date of observation of a progression of the disease according to RECIST 1.1 or death of the patient (all causes combined) or date of last follow-up if the patient is alive without progression or lost to follow up.

    Measured: 6 years

  2. Duration of response between both treatment arms.

    Duration of response among patients who had a response (CR/PR) after the 4 induction cycles. It is defined by the time between first response observed (i.e. randomization date) and first event observed (progression, secondary malignancy or death in case of no previous progression).

    Measured: 6 years

  3. Assessment of quality of life between both treatment arms via the EORTC QLQ-C30 questionnaire.

    Patient reported outcomes via the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (EORTC QLQ-C30).

    The EORTC QLQ-C30 was developed to assess the quality of life of cancer subjects and is the most widely used cancer-specific HRQoL instrument. It contains 30 items and measures five functional dimensions (physical, role, emotional, cognitive, and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact) and global health and quality of life. The global health and quality of life scale uses a 7-point scale scoring with anchors (1=very poor and 7=excellent); the other items are scored on a 4 point scale (1=not at all, 2=a little, 3= quite a bit, 4=very much).

    Measured: 6 years

  4. Assessment of quality of life between both treatment arms via the EORTC QLQ-LC13 questionnaire.

    Patient reported outcomes via the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13).

    The EORTC QLQ-LC13 covers 13 typical symptoms of lung cancer patients, such as coughing, pain, dyspnea, sore mouth, peripheral neuropathy, and hair loss. It is scored on a 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much).

    Measured: 6 years

  5. Assessment of quality of life between both treatment arms via the EQ-5D-5L questionnaire.

    Patient reported outcomes via the 5-level EuroQol-5D (EQ-5D-5L questionnaire).

    The EQ-5D-5L essentially consists of five health state dimensions include the following: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a five-point scale from 1 (extreme problem) to 5 (no problem). The EQ-5D-5L also includes a graded (0 = The worst health you can imagine, to 100 = The best health you can imagine) vertical visual analog scale on which the subject rates his or her general state of health at the time of the assessment.

    Measured: 6 years

  6. Treatment tolerance in both treatment arms

    Frequency of adverse events according to CTCAE V5

    Measured: 6 years

  7. Economic evaluation

    An important cost reduction per patient associated to treatment de-escalation is expected. We will compare the costs between the two arms. Time horizon extends from randomization to the date of last follow-up.

    Direct medical costs will be estimated from the French national health insurance perspective (Système National des Données de Santé, SNDS).

    Measured: 6 years

  8. Population pharmacokinetic analysis in both arms (primary objective)

    The primary objective of the PK study will be to evaluate the systemic exposition (Ctrough) of pembrolizumab in both arms.

    Measured: 6 years

  9. Population pharmacokinetic analysis in both arms (secondary objective)

    The secondary objective of the PK study will be to use the clearance evolution of the pembrolizumab as marker of the response to explore the potential correlation between clearance evolution and the survival.

    Measured: 6 years

  10. Evaluate the saturation of PD-1 on circulating lymphocytes in both arms

    Calculate the % of saturation of PD-1 on fresh circulating lymphocytes at baseline and during treatment in both arms.

    Measured: 6 years

  11. Evaluate the target engagement pharmacodynamics (PD) in both arms

    Target engagement pharmacodynamics (PD) will be assayed using the interleukin-2 (IL-2) stimulation ratio at baseline and during treatment in both arms.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2023
  2. Study start20 Mar 2023
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,166 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05692999
Sponsor's protocol ID
2021-006795-16
Other IDs
2021/3336, 2023-503481-23-00, 2023
Acronym
Pulse
Status last verified
Jun 2025
First submitted
20 Dec 2022
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pembrolizumab 200 mg Q6W, Pemetrexed 500 mg/m^2 Q3W and Pembrolizumab 200 mg Q3W or 400 mg Q6W in people with Metastatic Non-squamous Lung Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 37 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in France, Spain, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Benjamin BESSE (+33(0)1 42 11 62 61, Benjamin.BESSE@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05692999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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