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. 2023 Apr 3;29(5):1092–1102. doi: 10.1038/s41591-023-02297-5

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© The Author(s) 2023

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — a, NANT 2015-02 study design. b, Treatment regimen by cohort. c, Patient distribution. *Cohort B2 opened at 95 mg/m² once cohort A1, DL4 (95 mg/m²) was deemed tolerable and safe. B2 did not dose escalate to 115 mg/m² until both B2, DL4 (95 mg/m²) in chemotherapy combination and cohort A1, DL5 (115 mg/m²) as single agent were deemed tolerable and safe. ^&Amendment 4: Additional doses of lorlatinib were added to dose-escalation cohorts A1 and A2 based on safety/PK data at the lower doses achieved, and pre-clinical data showing lorlatinib doses required for anti-neuroblastoma potency were higher than NSCLC pre-clinical models. ^#Topo/Cy, topotecan/cyclophosphamide; MGF, myeloid growth factor; **PD, progressive disease. PO, orally; QD, once a day.