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A Pilot Phase II Study of Maintenance Cabozantinib Plus Pembrolizumab for Patients With Metastatic Squamous Non-Small Cell Lung Cancer (sqNSCLC)

Study acronym: LUNG-IST-127
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 7 of 7 entriesv9
  2. Primary endpoints: 2 to 1 Interventions: Cabozantinib 40 MG (Drug), Pembrolizumab 200mg (Drug), Pembrolizumab 400mg (Drug) to Cabozantinib (Drug), Carboplatin or Cisplatin (Drug), Pacliltaxel or Nab-paclitaxel (Drug), Pembrolizumab (Drug) · Eligibility criteria shortened, about 24 words · Secondary endpoints: 6 to 7 · 1 morev8 Show 4 more changesShow less
    • Interventions: Cabozantinib 40 MG (Drug), Pembrolizumab 200mg (Drug), Pembrolizumab 400mg (Drug) to Cabozantinib (Drug), Carboplatin or Cisplatin (Drug), Pacliltaxel or Nab-paclitaxel (Drug), Pembrolizumab (Drug)
    • Eligibility criteria shortened, about 24 words
    • Secondary endpoints: 6 to 7
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  3. Enrollment target: 325 to 36v7
  4. Eligibility criteria revisedv6 See this version in full on ClinicalTrials.gov ↗
  5. Interventions: Cabozantinib 40 MG (Drug), Pembrolizumab 200mg (Drug) to Cabozantinib 40 MG (Drug), Pembrolizumab 200mg (Drug), Pembrolizumab 400mg (Drug) Eligibility criteria expanded, about 47 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 47 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Study site revisedv4 See this version in full on ClinicalTrials.gov ↗
  2. Start date changed from estimate of Dec 2022 to Dec 28, 2022v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date: Nov 2022 to Dec 2022 · Study description shortened, about 6 words · 1 morev2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Start date: Nov 2022 to Dec 2022
    • Study description shortened, about 6 words
    • Study title shortened, about 1 word

    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a phase II study to assess the efficacy, safety, and Health Related Quality of Life (HRQoL) of combination cabozantinib and pembrolizumab as maintenance therapy for patients with metastatic squamous Non Small Cell Lung Cancer(sqNSCLC) who have received 4 cycles of induction therapy with pembrolizumab, carboplatin, and nab-paclitaxel or paclitaxel.
Trial Details
NCT Number NCT05613413
Lead Sponsor University of Illinois at Chicago
Conditions Metastatic Squamous Non-Small Cell Lung Carcinoma
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov