Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L) (ZEAL-1L)
Interventional
Phase 3
GlaxoSmithKline (Voir sur ClinicalTrials)
octobre 2020
juin 2025
27 décembre 2024
This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib
plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in
participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have
achieved stable disease (SD), partial response (PR), or complete response (CR) following
completion of standard of care first-line platinum-based induction chemotherapy with
pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC
could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with
respect to Progression-free survival (PFS) and Overall survival (OS).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Christos CHOUAID | 29/03/2024 01:29:18 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| GSK Investigational Site - 29609 - Brest cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 31059 - Toulouse cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 38043 - Grenoble cedex 9 - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 44093 - Saint-Herblain - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 67200 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 75018 - Paris - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 83056 - Toulon cedex - France | Contact (sur clinicalTrials) | ||||
| GSK Investigational Site - 94010 - CrEteil cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion criteria:
- Participant must be >=18 years of age.
- Has a histologically or cytologically confirmed diagnosis of NSCLC without known
targetable driver alteration (either non-squamous or squamous histology; mixed
histology is allowed for which an approved targeted therapy is available in the 1L
induction/maintenance therapy setting).
- Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive
chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
- Has completed at least 4 but no more than 6 cycles of standard of care first-line
platinum-based induction chemotherapy with pembrolizumab.
- Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4
to 6 cycles of standard of care first-line platinum-based induction chemotherapy
with pembrolizumab.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 12 weeks.
- Has adequate organ and bone marrow function.
- Must submit tumor specimens.
- Must be able to swallow and retain orally administered study treatment.
- A female is eligible to participate if she is not pregnant or breastfeeding, and
must follow contraceptive guidance during the treatment period and 180 days
afterwards.
- A male is eligible to participate if he agrees to contraceptive guidance and
refrains from sperm donation during the intervention period and for at least 90 days
after the last dose of study treatment.
- Is able to understand the study procedures and agrees to participate in the study by
providing written informed consent. Participants must be informed that their
participation is voluntary. Participants will be required to sign a statement of
informed consent to participate in the study.
- Participant must be >=18 years of age.
- Has a histologically or cytologically confirmed diagnosis of NSCLC without known
targetable driver alteration (either non-squamous or squamous histology; mixed
histology is allowed for which an approved targeted therapy is available in the 1L
induction/maintenance therapy setting).
- Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive
chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
- Has completed at least 4 but no more than 6 cycles of standard of care first-line
platinum-based induction chemotherapy with pembrolizumab.
- Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4
to 6 cycles of standard of care first-line platinum-based induction chemotherapy
with pembrolizumab.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 12 weeks.
- Has adequate organ and bone marrow function.
- Must submit tumor specimens.
- Must be able to swallow and retain orally administered study treatment.
- A female is eligible to participate if she is not pregnant or breastfeeding, and
must follow contraceptive guidance during the treatment period and 180 days
afterwards.
- A male is eligible to participate if he agrees to contraceptive guidance and
refrains from sperm donation during the intervention period and for at least 90 days
after the last dose of study treatment.
- Is able to understand the study procedures and agrees to participate in the study by
providing written informed consent. Participants must be informed that their
participation is voluntary. Participants will be required to sign a statement of
informed consent to participate in the study.
- Has mixed small cell lung cancer or sarcomatoid variant NSCLC.
- Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP)
inhibitor(s) in prior lines of treatment.
- Has systolic blood pressure (BP) >140 millimeters of mercury (mmHg) or diastolic BP
>90 mmHg.
- Has any clinically significant gastrointestinal abnormalities that may alter
absorption such as malabsorption syndrome or major resection of the stomach and/or
bowels.
- Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases,
or radiographic signs of CNS hemorrhage.
- Has received colony-stimulating factors (granulocyte macrophage colony-stimulating
factor or recombinant erythropoietin) within 4 weeks prior to the first dose of
study treatment.
- Has an active or previously documented autoimmune or inflammatory disorder.
- Is receiving chronic systemic steroids (prednisone >20 mg per day) other than
intermittent use of bronchodilators, inhaled steroids, or local steroid.
- Has other active concomitant malignancy that warrants systemic, biologic, or
hormonal therapy.
- Is pregnant, breastfeeding, or expecting to conceive children while receiving study
treatment and/or for up to 180 days after the last dose of study treatment.
- Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia
(AML).
- Has a known history of active tuberculosis.
- Has current active pneumonitis within 90 days of planned start of the study or a
known history of interstitial lung disease, drug-related pneumonitis, or radiation
pneumonitis requiring steroid treatment.