Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Effects of Infusion Timing on Treatment Response in Solid Tumors (TIMED)

14 september 2026 uppdaterad av: UNC Lineberger Comprehensive Cancer Center

Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors

This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

238

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599
        • Rekrytering
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology
        • Kontakt:
        • Huvudutredare:
          • Shetal A Patel, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

Cohort 1A and 1B:

  • Participants with metastatic non-small cell lung cancer (NSCLC).
  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Subject is willing and able to comply with study procedures based on the judgement of the investigator.
  • Age ≥ 18 years at the time of consent.

Cohort 2A and 2B:

  • Participants with resectable head and neck squamous cell carcinoma (HNSCC)
  • Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Subject is willing and able to comply with study procedures based on the judgement
  • of the investigator.
  • Age ≥ 18 years at the time of consent.

Exclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)

  • Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.
  • Prior immune checkpoint inhibitors (ICI) such as programmed cell death protein 1(PD-1) or programmed death-ligand 1 (PD-L1) inhibitor or Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA4) treatment received less than 6 months from the time of screening.
  • Subject is participating in another treatment clinical trial.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cohort 1A: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start prior 12:00 PM
Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment before 12:00 PM.
Läkemedel: PD-1/PD-L1 inhibitor monotherapy - 4 cycles before 12:00PM
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered before 12:00PM for 4 cycles.
Experimentell: Cohort 1B: non-small cell lung cancer (NSCLC) received Anti- PD-1/PD-L1 start after 3:00 PM
Patients with advanced or metastatic non-small cell lung cancer (NSCLC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) therapy received treatment after 3:00 PM.
Läkemedel: PD-1/PD-L1 inhibitor monotherapy - 4 cycles after 3 PM
PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor monotherapy will be administered after 3 PM for 4 cycles.
Experimentell: Cohort 2A: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start prior 12:00 PM
Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC) eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment before 12:00 PM.
Läkemedel: PD-1 inhibitor monotherapy - 2 cycles before 12:00PM
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered before 12:00PM for 2 cycles.
Experimentell: Cohort 2B: head and neck squamous cell carcinoma (HNSCC) received Anti- PD-1 start after 3:00 PM
Patients with advanced or metastatic locally advanced, resectable head and neck squamous cell carcinoma (HNSCC)eligible for standard-of-care anti-PD-1 (programmed cell death protein 1) therapy received treatment after 3:00 PM.
Läkemedel: PD-1 inhibitor monotherapy - 2 cycles after 3 PM
PD-1 (programmed cell death protein 1) inhibitor monotherapy will be administered after 3 PM for 2 cycles.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression free survival (PFS) - non-small cell lung cancer (NSCLC)
Tidsram: Up to 2 years
Progression free survival (PFS) will be measured as the time from the date of randomization to the earliest date of radiographic disease progression (PD), as determined by RECIST 1.1, or death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Up to 2 years
Major Pathologic Response (MPR) -head and neck squamous cell carcinoma (HNSCC).
Tidsram: Up to 3 months
Major Pathologic Response (MPR) is defined as participant with ≤10% viable tumor in resected tumor tissue in patients with resectable head and neck squamous cell carcinoma (HNSCC).
Up to 3 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival (OS) - non-small cell lung cancer (NSCLC)
Tidsram: Up to 2 years
Overall survival (OS) is defined as the time from randomization to death from any cause in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Up to 2 years
Timing of surgery
Tidsram: Up to 3 months
Timing of surgery is defined as the time from the last neoadjuvant dose to the date of surgery.
Up to 3 months
Objective Response Rate (ORR) - non-small cell lung cancer (NSCLC)
Tidsram: Up to 2 years
Objective Response Rate defined as the proportion of patients achieving a Complete Response (CR) or Partial Response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 To determine if time of day of immune checkpoint inhibitor administration impacts treatment response in subjects with advanced or metastatic non-small cell lung cancer (NSCLC).
Up to 2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Utredare

  • Huvudutredare: Shetal A Patel, MD, UNC Lineberger Comprehensive Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

3 augusti 2026

Primärt slutförande (Beräknad)

1 januari 2033

Avslutad studie (Beräknad)

1 januari 2033

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juni 2026

Första postat (Faktisk)

5 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LCCC2526-DCT

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera