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- Klinische proef NCT04762030
Neoadjuvant Durvalumab/Anlotinib /Chemotherapy Plus Curative Resection in Stage III Non-Small-Cell Lung Cancer : A Single-arm Phase II Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Junqi Wu
- Telefoonnummer: 021-65115006
- E-mail: wujq0724@163.com
Studie Locaties
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Shanghai
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Shanghai, Shanghai, China, 200092
- Werving
- Shanghai Pulmonary Hospital
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Contact:
- Chang Chen, MD,PhD
- Telefoonnummer: +86 021-65115006
- E-mail: changchenc@tongji.edu.cn
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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:
- Written informed consent provided.
- Males or females aged ≥18 years.
- Pathologically diagnosed of non-small cell lung cancer.
- Diagnosed as stage III.
- Tumor should be considered resectable before study entry by a multidisciplinary team.
- ECOG (Performance status) 0-1.
Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to treatment.
i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin > 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or >40% predicted value viii. INR/APTT within normal limits.
- Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
- All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
- Patient capable of proper therapeutic compliance and accessible for correct follow-up.
- Measurable or evaluable disease (according to RECIST 1.1 criteria).
Exclusion Criteria:
- All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
- central type, with empty lung squamous cell carcinoma or non-small cell lung cancer with hemoptysis (>50 mL/day).
- Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
- Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy.
- Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
- Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
- Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
- Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Patients with history of allergy to study drug components excipients. Women who are pregnant or in the period of breastfeeding.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Experimentele groep
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Neoadjuvant treatment (durvalumab+carboplatin+nab-paclitaxel + anlotinib) will start within 1-3 days from enrollment. 2 cycles will be administered at 21-day (+/- 3 days) intervals (QW3). Then, two cycles of combined durvalumab and anlotinib (QW3) will be administered prior to surgery. Before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 5rd-7th week from day 1 cycle 4 of neoadjuvant treatment (day 35-49 after day 1 of cycle 4). Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Twelve cycles of durvalumab adjuvant treatment (Q4W) will be administered. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
PFS at 24 months
Tijdsspanne: 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
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The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first.
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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
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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, fytogeen
- Antineoplastische middelen, immunologisch
- Carboplatine
- Paclitaxel
- Durvalumab
Andere studie-ID-nummers
- NALAN-02
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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 .
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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 Durvalumab Anlotinib Carboplatin Nab-paclitaxel
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Di WuWerving
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The First Affiliated Hospital of Zhengzhou UniversityWerving
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Wuhan Union Hospital, ChinaOnbekendKleincellige longkanker | Anlotinib | Durvalumab
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Fudan UniversityActief, niet wervendTNBC - Triple-negatieve borstkankerChina
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Voltooid
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IFOM ETS - The AIRC Institute of Molecular OncologyAstraZenecaWervingDrievoudige negatieve uitgezaaide borstkankerItalië
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Chinese PLA General HospitalWervingAlvleesklierkanker | GalwegkankerChina
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Sichuan Provincial People's HospitalWerving
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Nanfang Hospital, Southern Medical UniversityNog niet aan het wervenNeoadjuvante therapie | Slokdarmcarcinoom
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Nanfang Hospital of Southern Medical UniversityWerving