The combination of neoadjuvant immunotherapy plus chemotherapy has recently been shown to improve survival outcome compared to chemotherapy alone and was recently approved for resectable non-small cell lung cancer (NSCLC). Despite so, recurrence risk of NSCLC after surgical resection remains high. Sacituzumab govitecan, a novel antibody drug conjugate, was demonstrated to be clinically active in metastatic NSCLC. This study aims to study the clinical efficacy of sacituzumab govitecan plus immunotherapy in resectable NSCLC. This is a open-label, single arm, multicentre, phase II study. Patients with EGFR/ALK negative, stage II-III (AJCC 8th edition), resectable NSCLC are eligible and will receive 4 cycles of neoadjuvant pembrolizumab plus sacituzumab govitecan, followed by surgical resection of tumour, and then 13 cycles of maintenance pembrolizumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
* 4 cycles, each cycle lasting for 3 weeks * 10mg/kg given every day 1 and day 8 each cycle * IV infusion
* 4 cycles, each cycle lasting for 3 weeks in Neoadjuvant phase; after surgery, 13 cycles, each cycle lasting for 3 weeks in Maintenance phase. * 200mg fixed dose every day 1 each cycle * IV infusion
Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, Hong Kong
Department of Clinical Oncology, Queen Elizabeth Hospital
Hong Kong, Hong Kong
Department of Clinical Oncology, Tuen Mun Hospital
Hong Kong, Hong Kong
Department of Oncology, Princess Margaret Hospital
Hong Kong, Hong Kong
Pathological complete response (pCR) rate in the intention-to-treat population
Time frame: 2 years
Resection rate after neoadjuvant SG and pembrolizumab combination: proportion of patients who undergo surgery with curative intent
Time frame: 2 years
pCR rates in patients who undergo surgery
Time frame: 2 years
Major pathological response (MPR) rate in the ITT population and in patients who undergo surgery: MPR is defined as less than 10% viable tumor cells in resected primary tumour specimen
Time frame: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on neoadjuvant SG and pembrolizumab combination
Time frame: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 while on adjuvant pembrolizumab
Time frame: 2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 first 30 days after surgery
Time frame: 2 years
Objective response rate (ORR): rate of partial and complete response on CT scans according to RECIST criteria ver 1.1
Time frame: 2 years
Overall Survival
Time frame: 2 years
12 month and 24 month event-free survival (EFS) rate
Time frame: 2 years
Patient reported quality of life (QOL), as measured by EQ-5D-3L during study treatment.
For the descriptive system of EQ-5D-3L, three levels of problems are described in each dimension. For the Visual Analogue Scale (VAS), the overall health assessment of the respondent is captured, ranging from 0 (worst health imaginable) to 100 (best health imaginable)
Time frame: 2 years
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