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Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 77% 230 → 53 participants
See other at-risk trials from Canadian Cancer Trials Group

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment reduced: 230 → 53 participants
    • Enrollment closed, study ongoing
    • Site details revised at 11 of 11 sites
    v26
  2. Study sites: 10 to 11v25
  3. Study sites: 6 to 10
    • Study description expanded, about 30 words
    • Study title expanded, about 1 word
    v24
  4. Eligibility criteria expanded, about 157 wordsv23
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Study description shortened, about 19 wordsv21
  2. Phase: Phase 2 to Phase 2/3v20 Show 10 more changesShow less
    • Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 50 to 230
    • Primary completion date: Dec 31, 2023 to Dec 31, 2026
    • Primary endpoints: 1 to 3
    • Study completion date: Jul 30, 2024 to Jul 30, 2027
    • Eligibility criteria expanded, about 177 words
    • Secondary endpoints: 5 to 14
    • Site details revised at 6 of 6 sites
    • Study arms: 1 to 2
    • Study title shortened, about 2 words
  3. Start date: Oct 17, 2019 to May 26, 2020v19
  4. Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Study completion date: Jul 30, 2023 to Jul 30, 2024
    v18
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v17
  6. Primary completion date: Jan 31, 2022 to Dec 31, 2022
    • Study completion date: Sep 30, 2022 to Jul 30, 2023
    v16
  7. Eligibility criteria shortened, about 25 wordsv15
  8. Site contacts updated at 1 of 6 sitesv14
  9. Eligibility criteria expanded, about 20 wordsv13
  10. Primary completion date: Mar 31, 2022 to Jan 31, 2022
    • Study completion date: Dec 31, 2022 to Sep 30, 2022
    v12
  11. Primary completion date: Mar 31, 2021 to Mar 31, 2022
    • Study sites: 5 to 6
    • Study completion date: Dec 31, 2021 to Dec 31, 2022
    v11
  12. Eligibility criteria shortened, about 197 wordsv10
  13. Study sites: 4 to 5v9
  14. Study sites: 3 to 4v8
  15. Primary completion date: Mar 2021 to Mar 31, 2021
    • Study completion date: Dec 2021 to Dec 31, 2021
    v7
  16. Study sites: 2 to 3v6
  17. Study sites: 1 to 2v5
  18. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 30, 2019 to Oct 17, 2019
    v4
  19. Study title revisedv3
  20. Start date: Sep 30, 2019 to Dec 30, 2019
    • Collaborators revised (3)
    v2
  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.
The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.
Trial Details
NCT Number NCT04093167
Lead Sponsor Canadian Cancer Trials Group
Collaborators: Cancer Research Institute, New York City, Personal Genome Diagnostics, Mark Foundation for Cancer Research
Conditions
(from sponsor)		 Lung Cancer
Related terms Lung Neoplasms
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov