A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement

Duration of response (DOR) assessed by Independent Review Committee per RECIST v1.1.

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Number of patients with adverse events and serious adverse events.

Time frame: Every cycle (4-week cycles) until study discontinuation, approximately 24 months.

Number of patients with dose interruptions.

Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

Number of patients with dose reductions.

Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

Number of patients with dose discontinuations.

Time frame: Every 28-day cycle until end of treatment, approximately 24 months.

Objective Response Rate (ORR) as assessed by Investigator per RECIST v1.1.

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Duration of Response (DOR) as assessed by Investigator per RECIST v1.1.

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months

Disease control rate (DCR) as assessed by Investigator and Independent Review Committee per RECIST v1.1.

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.

Progression-free survival (PFS) as assessed by Investigator and Independent Review Committee per RECIST v1.1.

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months

Overall survival (OS).

Time frame: Up to approximately 36 months.

Time to response (TTR) assessed by Investigator and Independent Review Committee per RECIST v1.1.

Time frame: Up to approximately 36 months.

Time to progression (TTP) assessed by Investigator and Independent Review Committee per RECIST v1.1.

Time frame: Up to approximately 36 months

Pharmacokinetic parameters including maximum plasma drug concentration (Cmax)

Time frame: [Time Frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)]

Pharmacokinetic parameters including area under the plasma concentration versus time curve (AUC)

Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

Pharmacokinetic parameters including half-life (t1/2)

Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through Cycle 4 (4-week cycles)

Change from baseline in quality of life as assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).

It scores (0-100) where higher means better function/quality of life in that section of the questionnaire and higher means worse symptoms in that section of the questionnaire.

Time frame: Approximately every 4 weeks during treatment, approximately 24 months

Time to deterioration (TTD).

Time frame: Up to approximately 36 months.

FGFR2 gene status in plasma circulating tumor deoxyribonucleic acid (ctDNA) and tumor tissue.

Time frame: Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months.

Pharmacodynamic parameters including changes in fibroblast growth factor 23 (FGF-23).

Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months.

Pharmacodynamic parameters including changes in carcinoembryonic antigen (CEA)

Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

Pharmacodynamic parameters including changes in cancer antigen 19-9 (CA 19-9)

Time frame: Approximately every 2 weeks in Cycle 1 (4-week cycle) and every other cycle (4-week cycles) from Cycle 3, approximately 24 months

Correlation between FGFR2 genotype by central tissue assessment and antitumor response, as measured by Objective Response Rate (ORR).

Time frame: Approximately every 8 weeks during treatment and every 12 weeks after the last dose in the absence of progressive disease, approximately 36 months.