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Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 194 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Site details revised at 2 of 280 sites
  2. Site details revised at 5 of 280 sites
  3. Site details revised at 1 of 280 sites
  4. Study sites: 279 to 280
  5. Site details revised at 1 of 279 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 23 of 279 sites
  2. Site details revised at 1 of 279 sitesv188
  3. Site details revised at 3 of 279 sitesv187
  4. Site details revised at 8 of 279 sitesv186
  5. Study sites: 278 to 279v185
  6. Site details revised at 1 of 278 sitesv184
  1. Trial sites expanded: 275 → 278 locationsv183
  2. Site contacts updated at 1 of 275 sitesv182
  3. Study sites: 274 to 275v181
  4. Study sites: 273 to 274v180
  5. Site details revised at 5 of 273 sitesv179
  6. Site details revised at 1 of 273 sitesv178
  7. Site details revised at 1 of 273 sitesv177
  8. Trial sites expanded: 266 → 271 locationsv176
  9. Study sites revised (271)v175 See this version in full on ClinicalTrials.gov ↗
  10. Study sites: 266 to 271v174
  11. Site details revised at 2 of 266 sitesv173
  12. Site details revised at 1 of 266 sitesv172
  13. Study sites: 265 to 266v171
  14. Study sites revised (265)v170 See this version in full on ClinicalTrials.gov ↗
  15. Trial sites expanded: 245 → 263 locationsv169
  16. Study sites: 245 to 263v168
  17. Study sites: 244 to 245v167
  18. Study sites: 243 to 244v166
  19. Trial sites expanded: 233 → 243 locationsv165
  20. Trial sites expanded: 230 → 233 locationsv164
  21. Site contacts updated at 1 of 230 sitesv163
  22. Site details revised at 1 of 230 sitesv162
  23. Study sites: 229 to 230v161
  24. Re-verified, no change to tracked fieldsv160
  25. Study sites: 228 to 229v159
  26. Study sites: 227 to 228v158
  27. Study sites revised (227)v157 See this version in full on ClinicalTrials.gov ↗
  28. Study sites: 226 to 227v156
  29. Study sites: 225 to 226v155
  30. Site details revised at 1 of 225 sitesv154
  31. Site details revised at 6 of 225 sitesv153
  32. Site details revised at 6 of 225 sitesv152
  33. Re-verified, no change to tracked fieldsv151
  34. Site details revised at 1 of 225 sitesv150
  35. Re-verified, no change to tracked fieldsv149
  36. Site details revised at 2 of 225 sitesv148
  37. Trial sites expanded: 221 → 225 locations Site details revised at 2 of 225 sitesv147 Show 1 more changeShow less
    • Site details revised at 2 of 225 sites
  38. Re-verified, no change to tracked fieldsv146
  39. Study sites: 221 to 225v145
  • 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 phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.
Trial Details
NCT Number NCT06498635
Lead Sponsor National Cancer Institute (NCI)
Conditions Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8
Enrollment 306 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov