PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 % (PERSEE)

September 16, 2025 updated by: University Hospital, Brest

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PERSEE is a french academic, prospective, randomized, controlled and open-label phase 3 study. This trial compares the combination of chemotherapy and pembrolizumab with pembrolizumab alone as first-line treatment for advanced NSCLC molecularly characterized by a PDL1 expression level ≥ 50% and no EGFR mutations or ALK rearrangement. This is a strategy trial whose primary objective is to evaluate the superiority of the chemotherapy-pembrolizumab combination over pembrolizumab using PFS as the primary endpoint as evaluated by an independent review committee.

PERSEE trial is planned to include 292 patients treated at approximately 30 GFPC-affiliated or GFPC-associated centres. After the screening period, patients will be randomized on a 1:1 basis to the Chemotherapy Immunotherapy Arm or the Immunotherapy Arm. Randomization will be stratified according to tumor histology (squamous versus non squamous) and according to the presence or absence of brain metastases. Patients enrolled in this study will receive either of the following treatment regimens:

  1. Chemotherapy-Immunotherapy Arm:

    Four induction cycles once every 3 weeks associating, on the first day of each cycle:

    • Cisplatin 75 mg/m² or carboplatin area under the curve (AUC) 5 mg/mL/min, pemetrexed 500 mg/m² and pembrolizumab 200 mg for non-squamous NSCLC.
    • Carboplatin AUC 6 mg/mL/min, paclitaxel 200 mg/m² and pembrolizumab 200 mg for squamous NSCLC.

    After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable, as follows:

    • Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy (if toxicity has been identified for one of them).
    • Squamous NSCLC: pembrolizumab monotherapy.

    For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

    For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

  2. Immunotherapy Arm:

Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.

Evaluations will be performed every 6 weeks (±7 days) during the first 4 cycles in both treatment arms, then every 9 weeks (±7 days) for the first 12 months since D1 of cycle 1 and every 12 weeks (±7 days) thereafter.

Evaluations will include: tumor assessment according to RECIST v1.1, survival status, concomitant medications and AE recording. QoL/PRO questionnaires will be performed at each cycle for the first 5 cycles in both treatment arms, then every 9 weeks (±7 days) for the first 12 months since D1 of cycle 1 and every 12 weeks (±7 days) thereafter.

The length of the inclusion period is 36 months (3 years). The total study duration per patient will be a maximum of two years for the last patients included, and a maximum of five years for the first patients included (i.e. End-of-study Time Point for surviving patients)

The total study duration includes the following:

  • Screening Period: up to 28 days.
  • Treatment Period: up to 60 months.
  • Post-study Follow up Period: until death or lost to follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
349

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13616
        • CH du Pays D'Aix
      • Amiens, France, 80054
        • CHU Amiens - Hopital Sud
      • Angers, France, 49033
        • CHU Angers
      • Brest, France, 29609
        • CHRU de Brest
      • Caen, France, 14000
        • Centre de Lutte contre le Cancer - Centre François Baclesse
      • Chambéry, France, 73000
        • Centre Hospitalier Metropole Savoie
      • Créteil, France, 94010
        • Ch Intercommunal de Creteil
      • La Roche-sur-Yon, France, 85000
        • CH La Roche Sur Yon - CHD Les Oudairies
      • Limoges, France, 87042
        • Chu Dupuytren
      • Lorient, France, 56100
        • CH de Lorient - Hôpital du Scorff
      • Lyon, France, 69008
        • Centre Léon Bérard
      • Marseille, France, 13003
        • Hôpital Européen Marseille
      • Marseille, France, 13000
        • Institut Paoli-Calmette
      • Marseille, France, 13915
        • CHU MARSEILLE_ Hopital Nord
      • Meaux, France, 77108
        • CH Meaux
      • Paris, France, 75014
        • APHP - Hopital Cochin
      • Pessac, France, 33604
        • CHU BORDEAUX - Hôpital du Haut Lévêque
      • Pringy, France, 74374
        • CH d'Annecy-genevois
      • Quimper, France, 29000
        • Centre Hospitalier de Cornouaille
      • Rennes, France, 35033
        • CHU RENNES - Hôpital Pontchailloux
      • Rouen, France, 76031
        • CHU ROUEN - Hôpital Charles Nicolle
      • Saint-Aubin-lès-Elbeuf, France, 76503
        • Saint Aubin Les Elbeuf
      • Saint-Denis, France, 97400
        • CH La Réunion - Site Félix Guyon
      • Saint-Pierre, France, 97410
        • CHU La Réunion - Groupe Hospitalier Sud
      • Saint-Priest-en-Jarez, France, 42271
        • SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire
      • Strasbourg, France, 67200
        • Institut de cancérologie Strasbourg Europe
      • Toulon, France, 83041
        • Hôpital d'Instruction des Armées Toulon - Saint Anne
      • Villefranche-sur-Saône, France, 69655
        • CH Villefranche sur Saone
      • Villejuif, France, 94800
        • Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Pembrolizumab
Drug: Pembrolizumab
Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.
Active Comparator: Chemotherapy-Pembrolizumab
Chemotherapy and Pembrolizumab
Drug: Pembrolizumab and Chemotherapy drugs

An induction therapy followed by a maintenance therapy.

4 induction cycles every 3 weeks associating, on the first day of each cycle:

  • Cisplatin 75mg/m² or carboplatin AUC 5mg/mL/min, pemetrexed 500mg/m² and pembrolizumab 200mg for non squamous NSCLC.
  • Carboplatin AUC 6mg/mL/min, paclitaxel 200mg/m² and pembrolizumab 200mg for squamous NSCLC.

After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable:

  • Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy.
  • Squamous NSCLC: pembrolizumab monotherapy.

For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) according to RECIST 1.1 assessed by blinded inependant centra review (BICR)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, according to RECIST 1.1 assessed by blinded inependant centra review (BICR)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression-free survival according to RECIST 1.1 evaluated by investigators
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Time from date of randomization until the date of first documented progression or death from any cause, whichever came first, according to RECIST v1.1 and evaluated by investigators
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Progression-free survival according to iRECIST assessed by blinded inependant centra review (BICR)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 60 months
Time from date of randomization until the date of first documented progression or death from any cause, whichever came first, according to iRECIST assessed by blinded inependant centra review (BICR)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first assessed up to 60 months
Objective Response Rate (ORR)
Time Frame: From date of first treatment administration until the date of first documented progression or death or the introduction of a new treatment, whichever came first, assessed up to 60 months
Proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST v1.1 from the date of first treatment administration until disease progression or the introduction of a new treatment.
From date of first treatment administration until the date of first documented progression or death or the introduction of a new treatment, whichever came first, assessed up to 60 months
Overall survival (OS)
Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months
Time from date of randomization until the date of death from any cause.
From date of randomization until the date of death from any cause assessed up to 60 months
Duration of treatment (DOT)
Time Frame: From date of the first treatment administration until the date of last treatment administration, up to 60 months
Time from the first treatment administration until the date of last treatment administration.
From date of the first treatment administration until the date of last treatment administration, up to 60 months
Duration of objective response (DOR)
Time Frame: From date of the first documented objective response (CR or PR) until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
Time from the first documented objective response (CR or PR) until the date of disease progression or death, whichever came first.
From date of the first documented objective response (CR or PR) until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
Adverse events (AE)
Time Frame: Up to 30 days after the last dose of study treatment for non-serious AEs. Up to 100 days or 30 days if initiating new treatment, after the last dose, for SAE.
Proportion (%) of patients with any adverse event (AE) and number of events per treatment arm for all AEs, all serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria.
Up to 30 days after the last dose of study treatment for non-serious AEs. Up to 100 days or 30 days if initiating new treatment, after the last dose, for SAE.
Adverse events of special interest (AESI)
Time Frame: Up to 100 days or 30 days if initiating new treatment, after the last dose.
Proportion (%) of patients with any adverse event of special interest (AESI), defined as immune-related AE (IrAE), according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria. .
Up to 100 days or 30 days if initiating new treatment, after the last dose.
PFS in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: From date of randomization until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
Time from date of randomization until the date of first documented progression or death from any cause, whichever came first, according to RECIST v1.1
From date of randomization until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
OS in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: From date of randomization until the date of death from any cause assessed up to 60 months
Time from randomization until the date of death from any cause.
From date of randomization until the date of death from any cause assessed up to 60 months
ORR in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: From date of first treatment administration until the date of first documented progression or death or the introduction of a new treatment, whichever came first, assessed up to 60 months
Proportion of patients who achieved a complete response (CR) or partial response (PR) according to RECIST v1.1
From date of first treatment administration until the date of first documented progression or death or the introduction of a new treatment, whichever came first, assessed up to 60 months
DOR in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: From date of the first documented objective response (CR or PR) until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
Time from the first documented objective response (CR or PR) until the date of disease progression or death, whichever came first.
From date of the first documented objective response (CR or PR) until the date of first documented progression or death from any cause, whichever came first, assessed up to 60 months
DOT in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: From date of the first treatment administration until the date of last treatment administration, assessed up to 60 months
Time from the first treatment administration until the date of last treatment administration.
From date of the first treatment administration until the date of last treatment administration, assessed up to 60 months
AE in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: Up to 30 days after the last dose of study treatment for non-serious AEs. Up to 100 days or 30 days if initiating new treatment, after the last dose, for SAE.
Proportion (%) of patients with any adverse event (AE) and number of events per treatment arm for all AEs, all serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria.
Up to 30 days after the last dose of study treatment for non-serious AEs. Up to 100 days or 30 days if initiating new treatment, after the last dose, for SAE.
AESI in three subgroups of patients according to PD-L1 expression (50-74%, 75-100%, and 90-100%), presence or absence of brain metastasis and histology (squamous versus non squamous).
Time Frame: Up to 100 days or 30 days if initiating new treatment, after the last dose.
Proportion (%) of patients with any adverse event (AE) and number of events per treatment arm for all AEs, all serious AEs (SAEs) and all AEs of grade ≥3 according to the National Cancer Institute (NCI) Common terminology criteria for adverse events (CTCAE) v5.0 criteria.
Up to 100 days or 30 days if initiating new treatment, after the last dose.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Early progression rate
Time Frame: Up to 6 weeks from the first day of treatment
proportion of patients with clinical and/or radiological tumor progression according to RECIST v1.1 before or at the first radiological evaluation at 6 weeks
Up to 6 weeks from the first day of treatment
Following of the quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Cancer patients.
Time Frame: Up to 60 months

The EORTC QLQ-C30 is a questionnaire with 30 questions developed to assess the quality of life of cancer patients.

An essential aspect of the "modular" approach to QOL assessment adopted by the EORTC Quality of Life Group is the development of modules specific to tumour site, treatment modality, or a QOL dimension, to be administered in addition to the core questionnaire (EORTC QLQ-C30). Mini: 42. Maxi: 114. Hisher score mean worse outcome.
Up to 60 months
Following of the quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Lung Cancer patients.
Time Frame: Up to 60 months
The EORTC Study Group on Quality of Life has developed a modular system for assessing the quality of life of cancer patients in clinical trials composed of two basic elements: (1) a core quality of life questionnaire, the EORTC QLQ-C30, covering general aspects of health-related quality of life, and (2) additional disease- or treatment-specific questionnaire modules. Two international field studies were carried out to evaluate the practicality, reliability and validity of the core questionnaire, supplemented by a 13-item lung cancer-specific questionnaire module, the EORTC QLQ-LC13.The lung cancer questionnaire module comprises both multi-item and single-item measures of lung cancer associated symptoms (i.e. coughing, haemoptysis, dyspnoea and pain) and side-effects from conventional chemo- and radiotherapy (i.e. hair loss, neuropathy, sore mouth and dysphagia). Mini: 13. Maxi: 52. Higher score means worse outcome.
Up to 60 months
Following of the quality of life with European Quality of life 5 dimensions and 3 Levels
Time Frame: Up to 60 months
The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Mini: 0. Maxi: 100. Higher score means better outcome.
Up to 60 months
Exploratory analyses to identify novel biomarkers
Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Blood and tissue analyses to identify novel biomarkers of efficacy and resistance.
From date of randomization until the date of first documented progression, assessed up to 60 months
Progression-free survival 2 (PFS2) according to RECIST 1.1
Time Frame: time from randomization to tumor progression on second-line therapy, or death from any cause.
Time from randomization to tumor progression on second-line therapy, or death from any cause.
time from randomization to tumor progression on second-line therapy, or death from any cause.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Brest

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Groupe Francais De Pneumo-Cancerologie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Christos CHOUAID, MD, PhD, Service de pneumologie, CH intercommunal de Créteil
  • Principal Investigator: Renaud DESCOURT, MD, Institut de Cancérologie, CHU Brest, Hôpital Morvan
  • Principal Investigator: Chantal DECROISETTE, MD, Medical Oncology, Centre Léon Bérard, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 29BRC20.0159_GFPC01-2020
  • GFPC 01-2020 (Other Identifier: Groupe Français de Pneumo-Cancérologie)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning five years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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