Informations générales (source: ClinicalTrials.gov)
Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy (EVOKE-01)
Interventional
Phase 3
Gilead Sciences (Voir sur ClinicalTrials)
novembre 2021
mars 2025
19 octobre 2024
The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy
(SG), versus docetaxel in participants with advanced or metastatic (cancer that has
spread) non-small cell lung cancer (NSCLC).
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 01:30:14 | Contacter | ||
| CLCC INSTITUT CURIE | 04/09/2024 13:49:41 | Contact (sur clinicalTrials) | |||
| HOPITAL FOCH | Jaafar BENNOUNA | 21/10/2024 07:07:23 | 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 | |||||
| Centre Francois Baclesse - 14076 CEDEX 05 - Calvados - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Annecy Genevois - 74374 - Epagny Metz-tessy - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Chauny - 02300 - Chauny - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de la Côte Basque - 64100 - Bayonne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Departemental Vendee - 85925 - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Rouen - Hopitel Charles Nicolle - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHITS-Hopital Sainte Musse - 83056 - Toulon cedex - France | Contact (sur clinicalTrials) | ||||
| CHU de Bordeaux Hopital Haut leveque - 33600 - Pessac - France | Contact (sur clinicalTrials) | ||||
| CHU de CAEN - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU de Lille - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Poitiers - 86021 - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Chu Montpellier Hopital Arnaud de Villeneuve - 34295 CEDEX - Montpellier - France | Contact (sur clinicalTrials) | ||||
| CHU-Hopital Gabriel Montpied - 63000 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Clinique Victor Hugo - 72000 - Le Mans - France | Contact (sur clinicalTrials) | ||||
| GHR Sud Alsace - Hopital Emile Muller - 68100 - Mulhouse - France | Contact (sur clinicalTrials) | ||||
| Hopital Dupuytren (CHU de Limoges) - 87042 - Limoges cedex - France | Contact (sur clinicalTrials) | ||||
| Hopital Foch - Saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud - 69495 - Pierre Benite - France | Contact (sur clinicalTrials) | ||||
| Institut Cancérologie Strasbourg Europe - 67033 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de l'Ouest - Paysde Loire (site SAINT HERBLAIN) - 44805 - saint Herblain - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Pathologically documented non-small cell lung cancer (NSCLC) with documented
evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American
Joint Committee on Cancer, Eighth Edition).
- Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and
programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are
required. Testing prior to enrollment. Resulting for other actionable genomic
alterations is recommended and to be performed as per local standard of care and
availability of targeted treatment. For patients with squamous cell carcinoma, EGFR
and ALK testing is optional.
- Must have progressed after platinum-based chemotherapy in combination with
anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody
(in either order) sequentially.
- No additional treatments are allowed in the recurrent/metastatic setting for
individuals with no actionable genomic alterations.
- Individuals with EGFR, ALK, or any other known actionable genomic alterations
must have also received treatment with at least 1 locally approved and
available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic
alteration.
- Documented radiographic disease progression while on or after receiving the
most recent treatment regimen for advanced or metastatic NSCLC.
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging
(MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before
randomization.
- Adequate hematologic counts without transfusional or growth factor support within 2
weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥
1500/mm^3, and platelets ≥ 100,000/μL).
- Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate
aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver
metastases, and serum albumin > 3 g/dL).
- Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault
equation.
- Male individuals and female individuals of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of
contraception.
Key
- Pathologically documented non-small cell lung cancer (NSCLC) with documented
evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American
Joint Committee on Cancer, Eighth Edition).
- Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and
programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are
required. Testing prior to enrollment. Resulting for other actionable genomic
alterations is recommended and to be performed as per local standard of care and
availability of targeted treatment. For patients with squamous cell carcinoma, EGFR
and ALK testing is optional.
- Must have progressed after platinum-based chemotherapy in combination with
anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody
(in either order) sequentially.
- No additional treatments are allowed in the recurrent/metastatic setting for
individuals with no actionable genomic alterations.
- Individuals with EGFR, ALK, or any other known actionable genomic alterations
must have also received treatment with at least 1 locally approved and
available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic
alteration.
- Documented radiographic disease progression while on or after receiving the
most recent treatment regimen for advanced or metastatic NSCLC.
- Measurable disease based on computed tomography (CT) or magnetic resonance imaging
(MRI) as assessed by the investigator in accordance with per RECIST Version 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before
randomization.
- Adequate hematologic counts without transfusional or growth factor support within 2
weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥
1500/mm^3, and platelets ≥ 100,000/μL).
- Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate
aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver
metastases, and serum albumin > 3 g/dL).
- Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault
equation.
- Male individuals and female individuals of childbearing potential who engage in
heterosexual intercourse must agree to use protocol-specified method(s) of
contraception.
Key
- Mixed small-cell lung cancer and NSCLC histology.
- Positive serum pregnancy test or women who are lactating.
- Received a prior anticancer biologic agent within 4 weeks prior to enrollment or
have received prior chemotherapy, targeted small molecule therapy, or radiation
therapy within 2 weeks prior to enrollment and have not recovered (ie, > Grade 2 is
considered not recovered) from adverse events (AEs) at the time of study entry.
Individuals participating in observational studies are eligible.
- Have not recovered (ie, > Grade 2 is considered not recovered) from AEs due to a
previously administered agent.
- Previously received treatment with any of the following:
- Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate
(ADC) containing a chemotherapeutic agent targeting topoisomerase 1
- Trop-2-targeted therapy
- Docetaxel as monotherapy or in combination with other agents
- Active second malignancy
- NSCLC that is eligible for definitive local therapy alone.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary
illnesses including, but not limited to, any underlying pulmonary disorder (ie,
pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic
obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any
autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement
(ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior
pneumonectomy.
- Known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
- Active cardiac disease
- Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or
gastrointestinal perforation within 6 months of enrollment.
- Active serious infection requiring antibiotics.
- Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications
that may interfere with SN-38 metabolism.
- Positive for hepatitis B surface antigen. Individuals who test positive for
hepatitis B core antibody will require hepatitis B virus DNA by quantitative
polymerase chain reaction for confirmation of active disease.
- Positive hepatitis C antibody and detectable hepatitis C viral load.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.