Testing Lutetium Lu 177 Dotatate in Patients With Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors

StatusRecruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 5 years 2 months later Jul 1, 2027 → Sep 1, 2032
See other at-risk trials from National Cancer Institute (NCI)

Record History

The 50 most recent of 229 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jul 1, 2027 to Sep 1, 2032
  2. Site details revised at 1 of 29 sites
  3. Site details revised at 4 of 29 sites
  4. Eligibility criteria shortened, about 30 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
    • Site details revised at 7 of 29 sites
  5. Site details revised at 1 of 29 sitesv225
Show 12 earlier versionsHide 12 earlier versions
  1. Site details revised at 1 of 29 sitesv224
  2. Site details revised at 1 of 29 sitesv223
  3. Study sites revised (29)v222
  4. Site details revised at 1 of 29 sitesv221
  5. Site details revised at 1 of 29 sitesv220
  6. Site details revised at 1 of 29 sitesv219
  7. Site details revised at 1 of 29 sitesv218
  8. Site details revised at 1 of 29 sitesv217
  9. Re-verified, no change to tracked fieldsv216
  10. Site details revised at 1 of 29 sitesv215
  11. Study sites revised (29)v214
  12. Site contacts updated at 1 of 29 sitesv213
  1. Primary completion pushed from Jul 1, 2026 to Jul 1, 2027
    • Study completion moved earlier from Jan 16, 2033 to Jul 1, 2027
    v212
  2. Site details revised at 1 of 29 sitesv211
  3. Site details revised at 1 of 29 sitesv210
  4. Site details revised at 1 of 29 sitesv209
  5. 29 versions Re-verified since Feb 27, 2026, no change to tracked fieldsv180-v208
  • 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 phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Lutetium Lu 177-dotate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177-dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Trial Details
NCT Number NCT04665739
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Lung Neuroendocrine Tumor, Functioning Lung Neuroendocrine Tumor, Locally Advanced Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Neoplasm, Lung Neuroendocrine Tumor G1, Lung Neuroendocrine Tumor G2, Metastatic Lung Neuroendocrine Neoplasm, Metastatic Lung Neuroendocrine Tumor +4 more
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov