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- Klinische proef NCT04023617
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and Nivolumab in patients.
Qualified patients were stratified by histological type (squamous cell carcinoma vs. non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio:
Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6 weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After the 48th week of assessment, a tumor assessment is required every 9 weeks until disease progression, withdrawal of informed consent, sponsor termination study, or patient death.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Beijing
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Beijing, Beijing, China, 100142
- Werving
- Beijing Cancer Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Men & women ≥18, and ≤75 years of age.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second line of treatment for advanced disease.
- The patient's tumor must be free of EGFR gene-sensitive mutations (including but not limited to exon 19 deletion mutation or exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X or exon 20 S768I site Mutation) and ALK gene rearrangement. If the pathology is squamous cell carcinoma or the tumor of a known patient has a KRAS mutation, then EGFR and ALK are not required to be detected.
- Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease.
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Expected survival time ≥ 12 weeks.
Has adequate organ and bone marrow function, defined as follows:
- Hemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count ≥1.5 × 109 /L.
- Platelet count ≥80 × 109 /L.
- Serum total bilirubin ≤ 1.5 × normal upper limit (ULN); for patients with liver metastasis, serum total bilirubin ≤ 5 × normal upper limit (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases: ALT and AST ≤ 5 × ULN.
- Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal (ULN).
- Pre-menopausal women have a negative urine or serum pregnancy test within 14 days prior to initiation of treatment.
- Written informed consent was signed prior to the experiment.
Exclusion Criteria:
- Have been treated with docetaxel or have previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or CTLA-4.
- Prior to randomization ≤ 21 days (or ≤ 5 half-lives, whichever is shorter) have received chemotherapy, other test drugs, and Chinese herbal medicines used to control cancer.
- Uncontrolled brain metastases and all meningeal metastases. Stereotactic radiotherapy within 7 days prior to the start of treatment in the first cycle, or brain metastases who underwent whole brain radiotherapy within the first 14 days (if the patient detected a new asymptomatic CNS metastasis during the screening scan, then radiotherapy must be received) And/or central nervous system metastases. After treatment, these patients do not require additional brain scans to enter the trial if other inclusion criteria are met.
- Large area radiotherapy (except for local palliative radiotherapy for bones).
- Pericardial effusion, pleural effusion, or ascites that is clinically uncontrolled and requires pericardial puncture, thoracic puncture, or abdominal puncture drainage within 2 weeks of randomization.
- A history of malignancy other than NSCLC within the first 5 years of randomization, except for malignant tumors with a very low risk of metastatic death and expected to heal after treatment (eg fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, accepted Localized prostate cancer for radical treatment, ductal carcinoma in situ for radical surgery).
- Have undergone major surgery (as defined by the investigator) within 28 days prior to the first dose. Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable.
- Any condition that, depending on the investigator's judgment, interferes with the evaluation of the efficacy of the study drug or explains the patient's safety or findings, including but not limited to: persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, Unstable angina, arrhythmia, or psychiatric/social conditions that affect the study's requirements, significantly increase the risk of AEs in the study drug, or affect the patient's ability to provide informed consent.
- Active or previously documented autoimmune or inflammatory disease (with vitiligo, hypothyroidism (after Hashimoto's syndrome) and stable disease after hormone replacement therapy, no active disease in the past 5 years Patients can be enrolled).
- Active infections, including tuberculosis, hepatitis B, and hepatitis C.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Nivolumab + Docetaxel
Nivolumab was administered at a dose of 300 mg on the first day of the 21-day cycle (every 3 weeks; q3w) when combined with docetaxel, and administered at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w) after stopping docetaxel treatment. On the first day of each cycle (21 days), docetaxel 75 mg/m2 was infused by IV on Day 1 of each 21-day cycle for 4-6 cycles (judged by investigator). |
Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
Andere namen:
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Actieve vergelijker: Nivolumab
Nivolumab was administered in the monotherapy group at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w).
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Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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PFS
Tijdsspanne: 24 maanden
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progressievrije overleving
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24 maanden
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Besturingssysteem
Tijdsspanne: 24 maanden
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algemeen overleven
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24 maanden
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Antineoplastische middelen
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Antineoplastische middelen, immunologisch
- Immuun Checkpoint-remmers
- Docetaxel
- Nivolumab
Andere studie-ID-nummers
- NIDO-101
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Carcinoom, niet-kleincellige long
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National Cancer Centre, SingaporeBeëindigdExtranodaal NK-T-CELL LYMFOMASingapore
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Adelphi Values LLCBlueprint Medicines CorporationVoltooidMastcelleukemie (MCL) | Agressieve systemische mastocytose (ASM) | SM w Assoc Clonal Hema Non-Mast Cell Lineage Disease (SM-AHNMD) | Smeulende systemische mastocytose (SSM) | Indolente systemische mastocytose (ISM) ISM-subgroep volledig gerekruteerdVerenigde Staten
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University of Alabama at BirminghamBeëindigdAnaplastisch grootcellig lymfoom | Angioimmunoblastisch T-cellymfoom | Perifere T-cellymfomen | Volwassen T-celleukemie | Volwassen T-cellymfoom | Perifeer T-cellymfoom niet gespecificeerd | T/Null Cell Systemisch Type | Cutaan t-cellymfoom met nodale / viscerale ziekteVerenigde Staten
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Masonic Cancer Center, University of MinnesotaWervingLymfoom | Folliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Myelofibrose | Juveniele myelomonocytaire leukemie | Burkitt lymfoom | Acute lymfatische leukemie | Lymfoblastisch lymfoom | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute leukemie | Mantelcellymfoom | Chronische myelogene... en andere voorwaardenVerenigde Staten
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Roswell Park Cancer InstituteActief, niet wervendAcute myeloïde leukemie | Polycytemie Vera | Myelofibrose | Chronische myelomonocytische leukemie | Waldenström Macroglobulinemie | Acute lymfatische leukemie | Chronische lymfatische leukemie | Secundaire acute myeloïde leukemie | Sikkelcelziekte | Myelodysplastisch syndroom | Plasmacelmyeloom | Chronische... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaActief, niet wervendFolliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Hodgkin lymfoom | Lymfoplasmacytisch lymfoom | Acute leukemie | Myelodysplastisch syndroom | Chronische myelogene leukemie | Prolymfatische Leukemie | Plasmacelleukemie | Beenmergfalensyndromen | Burkitt-lymfoom | Acute lymfoblastische leukemie... en andere voorwaardenVerenigde Staten
Klinische onderzoeken op Nivolumab
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Universitair Ziekenhuis BrusselNog niet aan het werven
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Brown UniversityBristol-Myers Squibb; The Miriam Hospital; Rhode Island Hospital; Women and Infants...BeëindigdBaarmoederhalskankerVerenigde Staten
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Bristol-Myers SquibbWervingMelanomaSpanje, Verenigde Staten, Italië, Chili, Griekenland, Argentinië
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Jason J. Luke, MDArray BioPharmaActief, niet wervendMelanoma | Niercelcarcinoom | Vaste tumor | Niet-kleincellige longkanker | Hoofd-hals plaveiselcelcarcinoomVerenigde Staten
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Baptist Health South FloridaBristol-Myers Squibb; NovoCure Ltd.BeëindigdRecidiverend glioblastoomVerenigde Staten
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HUYABIO International, LLC.Bristol-Myers SquibbWervingInoperabel of gemetastaseerd melanoom | Progressieve hersenmetastaseSpanje, Verenigde Staten, Italië, Japan, België, Frankrijk, Nieuw-Zeeland, Brazilië, Korea, republiek van, Australië, Duitsland, Singapore, Tsjechië, Oostenrijk, Zuid-Afrika, Verenigd Koninkrijk, Puerto Rico
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University of California, San FranciscoBristol-Myers Squibb; National Cancer Institute (NCI)VoltooidHiv/aids | Kaposi-sarcoom | ImmunosuppressieVerenigde Staten
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Parker Institute for Cancer ImmunotherapyBristol-Myers Squibb; Cancer Research Institute, New York CityVoltooidGevorderde uitgezaaide kanker | Vergevorderde prostaatkankerVerenigde Staten
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National Health Research Institutes, TaiwanNational Taiwan University Hospital; Mackay Memorial Hospital; China Medical University... en andere medewerkersWervingHepatocellulair carcinoom (HCC)Taiwan
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Universitätsklinikum Hamburg-EppendorfCharite University, Berlin, Germany; University Hospital, Essen; Westpfalz-Clinical...Actief, niet wervend