Nivolumab Combined With Anlotinib as Re-challenge Treatment in Advanced NSCLC
Status:
Recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
This is a phase Ib/IIa, open-label, single center study, aiming to investigate safety and
efficacy of nivolumab (administered intravenously) in combination with anlotinib
(administered orally) in immunotherapy-treated advanced NSCLC. The study has been designed to
allow an investigation of the optimal combination dose and schedule while ensuring the safety
of patients with intensive safety monitoring. There are two main parts to this study; Part A,
combination dose finding and Parts B, dose expansion. Part B will either be initiated if RP2D
reached in Part A, or not initiated if RP2D was not reached in Part A.
Part A has been designed to identify the recommended dose of combination of nivolumab plus
anlotinib for further clinical evaluation based upon assessment of the safety and
tolerability data collected during the first 21 days (cycle 1, 21 days per cycle). The 21-day
assessment period was selected as the major toxicities leading to cessation of dose
de-escalation in such Phase I oncology studies (haematological, gastrointestinal, liver
enzymes) are anticipated to present within this duration. "3+3"design was used in the dose
finding cohort.
If RP2D was reached in Part A, eligible patients would be enrolled and receive nivolumab
(360mg q3w, intravenously) plus anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) till
disease progression (PD) withdraw of consent, or unacceptable toxicity to further evaluate
the safety, tolerability and efficacy in terms of ORR , DCR, DOR, PFS and OS. The tumor
response will be evaluated according to RECIST Version 1.1 every 6 weeks.