Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.
A 2-Cohort, Phase 2, multicenter, parallel-design trial that will study patients with surgically resectable, stages I-IIIA, non-small cell lung cancer (NSCLC) . The clinical study will focus on whether FL-101 has direct anti-tumor activity when given alone prior to surgery, and if FL-101 improves the anti-tumor response when given in combination with nivolumab prior to surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
To evaluate the tolerability, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0 of FL-101 as monotherapy and in combination with nivolumab.
Time frame: From time of first dose to 3 months after surgery
Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.
Cohort 1: To evaluate the activity of FL-101 neoadjuvant monotherapy in patients with Stage IA3 or IB NSCLC Cohort 2: To evaluate the effect of FL-101 in combination with nivolumab compared to nivolumab plus placebo in neoadjuvant therapy in patients with Stage II-IIIA NSCLC
Time frame: At time of surgery (around 6-8 weeks)
Major Pathologic Response
To determine major pathologic response (MPR), defined as ≤10 percent viable tumor
Time frame: At time of surgery (around 6-8 weeks after first dose)
Complete Pathologic Response
To estimate complete pathologic response (CPR), defined as the absence of residual invasive cancer in resected lung specimens and lymph nodes
Time frame: At time of surgery (around 6-8 weeks after first dose)
Objective Response Rate (ORR)
To estimate objective response rate (ORR) by RECIST 1.1
Time frame: At time of surgery (around 6-8 weeks after first dose)
MRD measurement by ctDNA
To describe the time course of minimal residual disease (MRD) response by ctDNA and recurrence in correlation with clinical response
Time frame: From time of first dose to 3 months after surgery
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