Etude : EVOKE-01 / GS-US-577-6153

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : EVOKE-01 / GS-US-577-6153

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 24/06/2022
CIM10 - Localisation(s)
Informations principales
Titre : Étude internationale en ouvert de phase III, multicentrique, randomisée, évaluant le Sacituzumab Govitécan comparé au Docétaxel chez des patients atteints d’un cancer du poumon non à petites cellules (CPNPC) avancé ou métastatique avec progression pendant ou après une chimiothérapie à base de platine et une immunothérapie par anti-PD-1/PD-L1

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : The primary objective of this study is to compare overall survival (OS) of sacituzumab govitecan-hziy (SG) versus docetaxel in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/ programmed death ligand 1 (PD-L1) immunotherapy received either in combination or sequentially.

Participants will be randomly assigned in a 1:1 ratio to receive either SG or docetaxel.

- Experimental: Sacituzumab Govitecan-hziy (SG)
Participants will receive SG 10 mg/kg on Days 1 and 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) until progressive disease (PD), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

- Active Comparator: Docetaxel
Participants will receive docetaxel 75 mg/m^2 on Day 1 of a 21-day cycle (ie, once every 3 weeks) until PD, death, unacceptable toxicity, or another treatment discontinuation criterion is met.

Overall Survival (OS) [ Time Frame: Up to 30 months ]

- Progression-free Survival (PFS) Assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to 30 months ]
- Objective Response Rate (ORR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
- Duration of Response (DOR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
- Disease Control Rate (DCR) Assessed by Investigator per RECIST Version 1.1 [ Time Frame: Up to 30 months ]
- Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: First dose date up to 30 months plus 30 days ]
- Percentage of Participants Experiencing Laboratory abnormalities [ Time Frame: First dose date up to 30 months plus 30 days ]
- Mean Change From Baseline in Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) Total Score [ Time Frame: Baseline, Up to 30 Months ]
- Mean Change From Baseline in Shortness of Breath as Measured by NSCLC-SAQ [ Time Frame: Baseline, Up to 30 Months ]

Phase : III

Stade : Localement avancé à Métastatique

2, 3
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - 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).
- Testing for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death ligand 1 (PD-L1) is required. Testing for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment.
- Must have progressed after platinum-based chemotherapy in combination with anti-PD-L1 antibody OR platinum-based chemotherapy and anti-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 approved 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.
- 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.

--- Other protocol defined Inclusion/Exclusion criteria may apply ---

Critères de non-inclusion : - 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.

--- Other protocol defined Inclusion/Exclusion criteria may apply ---
Informations relatives au promoteur
Promoteur :
Gilead Sciences
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Alexis Cortot

Eric Wasielewski

Statut de l'essai : OUVERT

MAJ : 24/06/2022