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Clinical trial · no report yet · Phase 1/Phase 2
ARROW
Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
- NCT03037385 ↗
- Completed
- Hoffmann-La Roche
- Focused
We haven't built an HCP commentary report on ARROW yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Indexed commentary on ARROW so far
Podcasts, YouTube videos and X posts we have indexed that name the trial. It is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this.
| Channel | Indexed | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1/2 Study of the Highly-selective RET Inhibitor, BLU-667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
- Phase
- Phase 1/Phase 2
- Status
- Completed
- Conditions
- RET-altered Non Small Cell Lung Cancer; Medullary Thyroid Cancer; RET-altered Papillary Thyroid Cancer; RET-altered Colon Cancer; RET-altered Solid Tumors; Lung Neoplasm; Carcinoma, Non-Small-Cell Lung; Thyroid Diseases; Thyroid Neoplasm; Thyroid Cancer, Papillary; Carcinoma, Neuroendocrine; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Disease; Carcinoma, Bronchogenic; Bronchial Neoplasms; Endocrine System Diseases; Endocrine Gland Neoplasm; Head and Neck Neoplasms; Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Colonic Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasm; Digestive System Disease; Gastrointestinal Disease; Colonic Diseases; Intestinal Disease
- Interventions
- pralsetinib (BLU-667)
- Arms
- Phase 1 Dose Escalation · Experimental
- Phase 2 Dose Expansion · Experimental
- Enrollment
- 590
- Primary outcomes
- Phase 1 : Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of Pralsetinib
- Phase 1 and Phase 2: Number of Participants With AEs and Serious AEs (SAEs)
- Phase 2: Overall Response Rate (ORR)
- Sponsor
- Hoffmann-La Roche
- Start
- Mar 17, 2017
- Primary completion
- Mar 21, 2024
- Results posted
- Yes
- Registry record
- NCT03037385 · updated May 31, 2025
Publications
linked from the registry- Besse B, Subbiah V, Curigliano G, Bowles DW, Doebele RC, Mansfield AS, Baik CS, de Lima Lopes G, Paz-Ares L, Taylor MH, Tan DSW, Alonso G, Gadgeel SM, Kalemkerian GP, Ou SI, van der Wekken AJ, Becerra CR, Evangelist M, Griesinger F, Liu SV, Lou Y, Mazieres J, Melear JM, Narang M, Saxena A, Thomas M, Wang S, Thomassen A, Lee DH, Kim DW, Gainor JF. Final Efficacy and Safety Data From the Phase I/II ARROW Study of Pralsetinib in Patients With Advanced RET Fusion-Positive Non-Small Cell Lung Cancer. J Clin Oncol. 2026 May;44(13):1190-1197. doi: 10.1200/JCO-25-01489. Epub 2026 Mar 26. PubMed 41886723
- Haddad RI, Bischoff L, Applewhite M, Bernet V, Blomain E, Brito M, Busaidy NL, Campbell M, DeLozier O, Duh QY, Ehya H, Grady E, Guo T, Haymart M, Hunt JP, Kandeel F, Kotwal A, Lamonica DM, Lorch J, Mandel SJ, Markovina S, Mydlarz W, Nabell L, Raeburn CD, Rezaee R, Ridge JA, Ritter H, Roth MY, Salgado SA, Scheri RP, Shah JP, Sipos JA, Sippel R, Sturgeon C, Wirth LJ, Wong RJ, Worden F, Yeh MW, Darlow S, Cassara CJ, Sliker B. NCCN Guidelines(R) Insights: Thyroid Carcinoma, Version 1.2025. J Natl Compr Canc Netw. 2025 Jul;23(7):e250033. doi: 10.6004/jnccn.2025.0033. PubMed 40639400
- Subbiah V, Hu MI, Mansfield AS, Taylor MH, Schuler M, Zhu VW, Hadoux J, Curigliano G, Wirth L, Gainor JF, Alonso G, Adkins D, Godbert Y, Ahn MJ, Cassier PA, Cho BC, Lin CC, Zalutskaya A, Barata T, Trask P, Scalori A, Bordogna W, Heinzmann S, Brose MS. Pralsetinib in Patients with Advanced/Metastatic Rearranged During Transfection (RET)-Altered Thyroid Cancer: Updated Efficacy and Safety Data from the ARROW Study. Thyroid. 2024 Jan;34(1):26-40. doi: 10.1089/thy.2023.0363. PubMed 38009200
- Subbiah V, Burris HA 3rd, Kurzrock R. Revolutionizing cancer drug development: Harnessing the potential of basket trials. Cancer. 2024 Jan;130(2):186-200. doi: 10.1002/cncr.35085. Epub 2023 Nov 7. PubMed 37934000
- Griesinger F, Curigliano G, Subbiah V, Baik CS, Tan DS, Lee DH, Misch D, Garralda E, Kim DW, van der Wekken AJ, Gainor JF, Paz-Ares L, Liu SV, Kalemkerian GP, Bowles DW, Mansfield AS, Lin JJ, Smoljanovic V, Rahman A, Zalutskaya A, Louie-Gao M, Boral AL, Mazieres J. Pralsetinib in patients with RET fusion-positive non-small-cell lung cancer: A plain language summary of the ARROW study. Future Oncol. 2024 Feb;20(6):297-306. doi: 10.2217/fon-2023-0155. Epub 2023 Nov 2. PubMed 37916501
- Zhou Q, Zhao J, Chang J, Wang H, Fan Y, Wang K, Wu G, Nian W, Sun Y, Sun M, Wang X, Shi H, Zheng X, Yao S, Qin M, Shen Z, Yang J, Wu YL. Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non-small cell lung cancer. Cancer. 2023 Oct 15;129(20):3239-3251. doi: 10.1002/cncr.34897. Epub 2023 Jun 6. PubMed 37282666
- Subbiah V, Cassier PA, Siena S, Garralda E, Paz-Ares L, Garrido P, Nadal E, Vuky J, Lopes G, Kalemkerian GP, Bowles DW, Seetharam M, Chang J, Zhang H, Green J, Zalutskaya A, Schuler M, Fan Y, Curigliano G. Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial. Nat Med. 2022 Aug;28(8):1640-1645. doi: 10.1038/s41591-022-01931-y. Epub 2022 Aug 12. PubMed 35962206
- Popat S, Liu SV, Scheuer N, Hsu GG, Lockhart A, Ramagopalan SV, Griesinger F, Subbiah V. Addressing challenges with real-world synthetic control arms to demonstrate the comparative effectiveness of Pralsetinib in non-small cell lung cancer. Nat Commun. 2022 Jun 17;13(1):3500. doi: 10.1038/s41467-022-30908-1. PubMed 35715405
- Subbiah V, Hu MI, Wirth LJ, Schuler M, Mansfield AS, Curigliano G, Brose MS, Zhu VW, Leboulleux S, Bowles DW, Baik CS, Adkins D, Keam B, Matos I, Garralda E, Gainor JF, Lopes G, Lin CC, Godbert Y, Sarker D, Miller SG, Clifford C, Zhang H, Turner CD, Taylor MH. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021 Aug;9(8):491-501. doi: 10.1016/S2213-8587(21)00120-0. Epub 2021 Jun 9. PubMed 34118198
- Gainor JF, Curigliano G, Kim DW, Lee DH, Besse B, Baik CS, Doebele RC, Cassier PA, Lopes G, Tan DSW, Garralda E, Paz-Ares LG, Cho BC, Gadgeel SM, Thomas M, Liu SV, Taylor MH, Mansfield AS, Zhu VW, Clifford C, Zhang H, Palmer M, Green J, Turner CD, Subbiah V. Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study. Lancet Oncol. 2021 Jul;22(7):959-969. doi: 10.1016/S1470-2045(21)00247-3. Epub 2021 Jun 9. PubMed 34118197