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NT-I7 i kombination med atezolizumab ved tidligere ubehandlet, PD-L1-udtrykkende, lokalt avanceret eller metastatisk NSCLC

15. maj 2026 opdateret af: NeoImmuneTech

Et multicenter, åbent, enkeltarms fase II-studie til evaluering af antitumoreffektivitet og sikkerhed af NT-I7 i kombination med atezolizumab hos forsøgspersoner med tidligere ubehandlet, PD-L1-udtrykkende, lokalt avanceret eller metastatisk NSCLC

Dette er et multicenter, åbent, enkeltarmet fase II-studie til evaluering af antitumoreffektivitet og sikkerhed af NT-I7 i kombination med atezolizumab hos forsøgspersoner med PD-L1-udtrykkende (TPS ≥ 1%), metastatisk (stadie IV) ) eller lokalt fremskreden planocellulær eller ikke-pladeepitel NSCLC, som ikke har modtaget tidligere systemisk behandling i metastatisk eller lokalt fremskredent miljø. Berettigede forsøgspersoner skal have målbar sygdom i henhold til RECIST 1.1. Dette fase II-studie vil indskrive op til 83 forsøgspersoner.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main purpose of this study is to assess the preliminary anti-tumor activity of NT-I7 in combination with atezolizumab in subjects with programmed cell death ligand 1 (PD-L1)-expressing (tumor proportion score [TPS] ≥ 1%), locally advanced or metastatic squamous or non-squamous non-small cell lung cancer (NSCLC) who have not received prior systemic therapy for locally advanced or metastatic disease. The primary objective is evaluated based on the objective response rate (ORR) as assessed by investigators using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and immune RECIST (iRECIST).

Secondary objectives include further evaluation of the anti-tumor activity and efficacy of the combination therapy based on the duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) per RECIST 1.1 and iRECIST. In addition, the safety and tolerability of NT-I7 will be evaluated.

One treatment cycle is defined as 21 days (3 weeks). Atezolizumab is administered at a dose of 1200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) on Day 1 of each cycle. NT-I7 is administered at a dose of 1200 μg/kg via intramuscular (IM) injection once every 6 weeks (Q6W) on Day 1 of alternating cycles, starting on Cycle 1 Day 1. On days when both study drugs are administered, atezolizumab is given prior to NT-I7.

Each subject may participate for a maximum of 35 cycles (approximately 2 years) of study treatment. The last safety follow-up visit will occur 90 days after the last dose, meaning the total participant duration could be up to 27 months.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

33

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama
    • California
      • Cerritos, California, Forenede Stater, 90703
        • TOI Clinical Research
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern CT Hematology & Oncology Associates
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33916
        • Florida Cancer Specialists - South Research Office
      • Plantation, Florida, Forenede Stater, 33322
        • BRCR Medical Center
      • St. Petersburg, Florida, Forenede Stater, 33705
        • Florida Cancer Specialists - North Research Office
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Florida Cancer Specialists - East Research Office
    • Georgia
      • Athens, Georgia, Forenede Stater, 30607
        • University Cancer and Blood Center
    • Indiana
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40217
        • Norton Cancer Institute
      • Pikeville, Kentucky, Forenede Stater, 41501
        • Pikeville Medical Center, Inc.
    • Maine
      • South Portland, Maine, Forenede Stater, 04106
        • MaineHealth Cancer Care
    • Maryland
      • Salisbury, Maryland, Forenede Stater, 21801
        • TidalHealth Peninsula Regional, Inc.
    • New Jersey
      • Florham Park, New Jersey, Forenede Stater, 07932
        • Summit Health Medical Center
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • East Carolina University
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43219
        • Zangmeister Cancer Center
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • OHSU Knight Cancer Institute
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Tennessee Oncology - Chattanooga
      • Knoxville, Tennessee, Forenede Stater, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, Forenede Stater, 37203
        • Tennessee Oncology - Nashville
    • Texas
      • El Paso, Texas, Forenede Stater, 79915
        • Renovatio Clinical - El Paso
      • The Woodlands, Texas, Forenede Stater, 77380
        • Renovatio Clinical - The Woodlands

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Har histologisk eller cytologisk bekræftet metastatisk eller lokalt fremskreden NSCLC og har ikke modtaget tidligere systemisk behandling. Personer med lokalt fremskreden sygdom skal have trin III NSCLC og er ikke kandidater til kirurgisk resektion eller endelig kemoradiation
  • Tumor PD-L1 ekspression (TPS≥1%) som bestemt ved PD-L1 22C3 immunhistokemi lokal eller central assay.
  • Har målbar sygdom
  • Accepter at give screeningsbiopsi (eller arkivvæv) ved screening for at vurdere PD-L1
  • ØKOG 0-1
  • Tilstrækkelig hæmatologisk funktion og endeorganfunktion

Ekskluderingskriterier:

  • Tidligere systemisk anti-cancer terapi
  • NSCLC med EGFR, eller ALK, eller BRAF eller ROS eller RED eller andre genomiske tumorafvigelser, som har tilgængelig terapi
  • Forudgående strålebehandling inden for 2 uger efter start af studiebehandling
  • Kendt aktiv CNS-metastaser eller karcinomatøs meningitis
  • Alvorlige reaktioner på mAbs eller IV immunoglobulinpræparater
  • Autoimmun sygdomshistorie i de seneste to år

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: NT-I7 og atezolizumab
Deltagere uden tidligere systemisk behandling for avanceret NSCLC vil modtage 1200 μg/kg NT-I7 IM på dag 1 og hver 6. uge og atezolizumab IV 1200 mg hver 3. uge indtil sygdomsprogression.
Medicin: efineptakin alfa
1200 μg/kg NT-I7 administreret intramuskulært (IM) en gang hver 6. uge (Q6W) startende på cyklus 1. Behandlingen fortsættes op til maksimalt 35 cyklusser (ca. 2 år).
Andre navne:
  • NT-I7
Medicin: Atezolizumab
1200 mg atezolizumab administreret intravenøst ​​(IV) én gang hver 3. uge (Q3W) startende på cyklus 1. Behandlingen fortsættes op til maksimalt 35 cyklusser (ca. 2 år).
Andre navne:
  • Tecentriq

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate (ORR)
Tidsramme: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).

The percentage of subjects with a best overall response (BOR) of a complete response (CR) or partial response (PR), per RECIST 1.1 and iRECIST as determined by the investigator.

Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of Response (DoR)
Tidsramme: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Per RECIST v1.1, Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression). Under iRECIST, tumor response is classified as immune Complete Response (iCR) or immune Partial Response (iPR) using the same size thresholds as RECIST 1.1.
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Disease Control Rate (DCR)
Tidsramme: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
The proportion of subjects with a best overall response of CR, PR or SD, per RECIST 1.1 and iRECIST as determined by the investigator.
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Progression Free Survival (PFS)
Tidsramme: The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
The time from the first study treatment (Cycle 1, Day 1) to the first occurrence of progression or death from any cause, whichever occurs first, per RECIST 1.1 and iRECIST as determined by the investigator. Progression is defined using RECIST 1.1 as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of at least 5 mm. Furthermore, the appearance of one or more new lesions is also considered progression. Under iRECIST, initial progression is classified as immune unconfirmed progressive disease (iUPD). Progression is confirmed as immune confirmed progressive disease (iCPD) if a subsequent assessment (proportionately 4-8 weeks later) shows a further increase in tumor burden (an additional 5 mm increase in the sum of diameters of target or new lesions, or further progression of non-target lesions) or the appearance of additional new lesions.
The first on-study imaging assessment were performed every 6 weeks for the first 6 months and every 9 weeks, or more frequently if clinically indicated, until disease progression or treatment discontinuation (up to 2 years).
Overall Survival (OS)
Tidsramme: Up to 2 years
The time from first study treatment (Cycle 1, Day 1) to death from any cause.
Up to 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

NeoImmuneTech

Samarbejdspartnere

Roche Pharma AG

Efterforskere

  • Studiestol: Donghoon Choi, PhD, NeoImmuneTech

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. november 2021

Primær færdiggørelse (Faktiske)

28. august 2024

Studieafslutning (Faktiske)

19. september 2024

Datoer for studieregistrering

Først indsendt

14. juli 2021

Først indsendt, der opfyldte QC-kriterier

29. juli 2021

Først opslået (Faktiske)

2. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIT-119

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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