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PD-1 Inhibitor and Chemotherapy With Concurrent Irradiation at Varied Tumour Sites in Advanced Non-small Cell Lung Cancer

Study acronym: NIRVANA-LUNG
StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revised at 58 of 58 sitesv11 Show 1 more changeShow less
    • Site details revised at 58 of 58 sites
  2. Trial status: Active, Not Recruiting to Recruiting Primary completion date: Jan 22, 2026 to Dec 22, 2026 · Completion date: Jul 22, 2027 to Dec 22, 2026 · Site details revised at 58 of 58 sitesv10 Show 3 more changesShow less
    • Primary completion date: Jan 22, 2026 to Dec 22, 2026
    • Completion date: Jul 22, 2027 to Dec 22, 2026
    • Site details revised at 58 of 58 sites
  3. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Sep 21, 2026 to Jan 22, 2026 · Completion date: Sep 21, 2026 to Jul 22, 2027 · Start date: Mar 21, 2019 to Jan 24, 2018 · 1 morev9 Show 4 more changesShow less
    • Primary completion date: Sep 21, 2026 to Jan 22, 2026
    • Completion date: Sep 21, 2026 to Jul 22, 2027
    • Start date: Mar 21, 2019 to Jan 24, 2018
    • Site details revised at 58 of 58 sites
  4. Primary completion date: Mar 21, 2024 to Sep 21, 2026 Primary endpoint revised · Enrollment target: 460 to 327 · Study sites: 26 to 58 · 2 morev8 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 460 to 327
    • Study sites: 26 to 58
    • Completion date: Sep 21, 2024 to Sep 21, 2026
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 23 to 26 Eligibility criteria expanded, about 22 words · Secondary endpoints: 5 to 6v7 Show 2 more changesShow less
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

Show 5 earlier versionsHide 5 earlier versions
  1. Primary completion date: May 15, 2022 to Mar 21, 2024 Study sites: 10 to 23 · Completion date: May 15, 2023 to Sep 21, 2024 · Study title revisedv6 Show 3 more changesShow less
    • Study sites: 10 to 23
    • Completion date: May 15, 2023 to Sep 21, 2024
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Suspended to Recruiting Enrollment target: 510 to 460 · Study sites: 2 to 10 · Interventions: Anti-PD(L)-1 (Drug), Radiotherapy (Radiation) to Chemotherapy (Drug), Pembrolizumab (Drug), Radiotherapy (Radiation) · 2 morev5 Show 5 more changesShow less
    • Enrollment target: 510 to 460
    • Study sites: 2 to 10
    • Interventions: Anti-PD(L)-1 (Drug), Radiotherapy (Radiation) to Chemotherapy (Drug), Pembrolizumab (Drug), Radiotherapy (Radiation)
    • Eligibility criteria expanded, about 9 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Recruiting to Suspended Sponsor's reason: Temporary suspension since March 13 due to COVID-19 pandemic Site details revised at 2 of 2 sitesv4 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Apr 15, 2019 to Mar 21, 2019v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Apr 15, 2019 to Mar 21, 2019
  5. Start date: Jan 15, 2019 to Apr 15, 2019 Eligibility criteria expanded, about 10 wordsv2 Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Overall survival (OS) of patients with advanced (stage IIIB/IV) non-small-cell lung cancer (NSCLC) remains short after the first line of treatment with a median OS of 12.2 months in non squamous NSCLC and 9.2 months in squamous NSCLC . In this setting the programmed death 1/ligand 1 (PD-1/-L1) were targeted with nivolumab (IgG4) in advanced squamous and nonsquamous NSCLC leading to an increase of the 1-year OS rate of approximately 10-15% in both histologies. Nivolumab, pembrolizumab and atezolizumab are now considered a standard of care in 2nd line advanced NSCLC and in 1st line for pembrolizumab but but prognosis still remains poor in advanced NSCLC. Overall survival (OS) of patients with advanced (stage III/IV) NSCLC remains limited with a median OS of 12.2 months in non-squamous NSCLC and 9.2 months in squamous NSCLC if anti-PD1 alone. It is of around 16 months if pembrolizumab is combined with chemotherapy. Preclinical data indicates that anti-tumor efficacy is increased when anti-PD-1/-L1 are combined with irradiation (IR). Radiotherapy alone can elicit tumor cell death which can increase tumor antigen in the blood stream, favoring recognition by the immune system and its activation against tumor cells outside of the radiation field (="abscopal effect"). IR may also reverse acquired resistance to PD-1 blockade immunotherapy by limiting T-cell exhaustion. Because of these preclinical and clinical data several studies analysing the combination of IR and anti-PD1 in NSCLC are ongoing. Among them, two studies are testing the administration of IR and nivolumab in stage III NSCLC: the NCT02768558 phase III trial (RTOG), and the NCT02434081 phase II trial (ETOP). Antonia et al \[2017\] tested the use of anti-PD-L1 after chemoradiotherapy in unresectable stage III NSCLC. Median time to distant metastasis was increased (23.2 months vs. 14.6 months, p\<0.001). An increase of OS is consequently expected. However, no study involving concurrent RT and pembrolizumab combined with chemotherapy in advanced NSCLC is ongoing, which is the purpose of the present study, NIRVANA-Lung.
Trial Details
NCT Number NCT03774732
Lead Sponsor UNICANCER
Collaborators: National Cancer Institute, France
Conditions Non Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Non-Small Cell Carcinoma of Lung, TNM Stage 4
Enrollment 327 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov