Study J2N-MC-JZ01 (JZ01) is an individual-study appendix (ISA) under master protocol J2N-MC-JZNY, and represents participants from the completed originator study, clinical study LOXO-BTK-18001/J2N-OX-JZNA. Participants in the originator study will have the opportunity to continue their assigned study intervention or continue their follow-up visits by transitioning to this study. This study will evaluate the long-term safety and efficacy of pirtobrutinib.

Inclusion Criteria:

• Are currently enrolled and active in the originator study, 18001. A participant is considered active in the study if they are:
  • receiving study intervention
  • in the short-term follow-up period, or
  • in the long-term follow-up period.

Exclusion Criteria:

• Were a participant in the Phase 1b cohort of Study 18001.
• Are pregnant or intend to become pregnant during the study or within 30 days of last dose of study treatment or intend to breastfeed during the study or within 1 week of the last dose of study treatment.

Linear Clinical Research, Perth, Western Australia, 6009
Contact  +61 08 6382 5100
cancertrialshaem4@linear.org.au

Eli Lilly and Company

Phase 4

J2N-MC-JZ01