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A phase 1/2 trial of Selpercatinib in non-small-cell lung cancer and small-cell lung cancer, run by Eli Lilly and Company, active and no longer recruiting.
A Study of Selpercatinib (LOXO-292) in Participants With Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer (LIBRETTO-001) is a phase 1/2 interventional study registered as NCT03157128 by Eli Lilly and Company, with 857 participants enrolled, started 2017-05-02 and due to reach its primary completion in 2025-02-14. Interventions recorded: LOXO-292. Conditions listed: Non-Small Cell Lung Cancer, Medullary Thyroid Cancer, Colon Cancer, Any Solid Tumor. Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
857 enrolled.
95% CI 57.2 to 68.3; Figures from the ClinicalTrials.gov results section (first posted 2026-04-16), not from a publication · 95% CI 68.8 to 88.2 · 95% CI 69.9 to 84.2 · 95% CI 74.6 to 89.1 · 95% CI 50.1 to 64.2 · 95% CI 11.0 to 58.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Phase 2: Objective Response Rate (ORR) Based on Independent Review Committee (IRC) Assessmentprimary | Phase 2, Cohort 1: RET Fusion Solid Tumor | 307 | 62.9% | - | - | link |
| Phase 2, Cohort 2: RET Fusion Solid Tumor Without Standard Therapy | 74 | 79.7% | ||||
| Phase 2, Cohort 3: RET Mutant MTC | 143 | 77.6% | ||||
| Phase 2, Cohort 4: RET Mutant MTC Without Standard Therapy | 116 | 82.8% | ||||
| Phase 2, Cohort 5: Advanced RET Altered Solid Tumor | 201 | 57.2% | ||||
| Phase 2, Cohort 6: RET Inhibitor-Discontinued Participants | 16 | 31.3% |
A second publication from the RET Fusion-Positive Solid Tumors trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
RET fusion testing is standard in lung adenocarcinoma and selpercatinib the preferred first-line RET inhibitor, confirmed against chemo-immunotherapy in LIBRETTO-431.
Shares Medullary thyroid cancer, Selpercatinib, Eli Lilly (incl. Loxo), Thyroid cancer.
Shares LIBRETTO-431, Selpercatinib, RET fusion-positive non-small-cell lung cancer.
Shares Selpercatinib, RET fusion-positive non-small-cell lung cancer, Eli Lilly (incl. Loxo), Small-molecule kinase inhibitors.
Shares Selpercatinib, Eli Lilly (incl. Loxo), Thyroid cancer, Small-molecule kinase inhibitors.
Shares ARROW (thyroid cohorts), Medullary thyroid cancer, Selpercatinib, RET fusion-positive non-small-cell lung cancer.
Shares LIBRETTO-431, Selpercatinib, Eli Lilly (incl. Loxo), Thyroid cancer.
Shares Selpercatinib, RET fusion-positive non-small-cell lung cancer, Thyroid cancer, Small-molecule kinase inhibitors.
Shares LIBRETTO-431, Selpercatinib, Small-molecule kinase inhibitors, Non-small-cell lung cancer.