Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

30 patients will receive FL-101 prior to surgery.

30 patients will receive FL-101 and Nivolumab prior to surgery.

30 patients will receive Nivolumab and placebo prior to surgery.

200 mg administered intravenously every 2 weeks prior to surgery.

FL-101

240 mg administered intravenously every 2 weeks prior to surgery.

Placebo

Cassandra Choe-Juliak, MD

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.

Cohort 2 will be randomized. The investigator and participants will be masked.

FL-101 in Surgically Resectable Non-Small Cell Lung Cancer

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer

To evaluate the pharmacokinetics of FL-101 in patients with NSCLC

To evaluate the effect of FL-101 on pharmacodynamic biomarkers

To evaluate possible immunogenicity of FL-101

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.

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

To determine major pathologic response (MPR), defined as ≤10 percent viable tumor

To estimate complete pathologic response (CPR), defined as the absence of residual invasive cancer in resected lung specimens and lymph nodes

To estimate objective response rate (ORR) by RECIST 1.1

To describe the time course of minimal residual disease (MRD) response by ctDNA and recurrence in correlation with clinical response

Flame Biosciences

Bortezomib

Vorinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

Subjects will receive one of 3 doses of Velcade (at a dose of 1.0 - 1.6 mg/m2 once weekly for 3 weeks) and one of 4 doses of Vorinostat (at a dose of 100mg every day 3 times a week for 3 weeks to 300mg twice per day, 3 times per week for 3 weeks). Doses determined by a predetermined escalation schedule.

Velcade and Vorinostat

David R Jones, MD

The purpose of this study is to find out what effects (both good and bad) two medications (VELCADE and Vorinostat) have on patients who have certain types of lung cancer. The study is "dose escalating" meaning that patients will receive different doses of medication depending on when they enter the study. Participation in the study will last approximately 3 months and will include an initial screening visit, a visit once each week for 3 weeks to receive the study medications, and then 2 additional visits around the time of your surgery to remove your lung cancer tumor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FL-101 in Surgically Resectable Non-Small Cell Lung Cancer	NCT04758949	Non-Small Cell ...	FL-101 Nivolumab Placebo	18 Years -	Flame Biosciences
Phase I Study of Induction Therapy With VELCADE and Vorinostat in Patients With Surgically Resectable Non-Small Cell Lung Cancer	NCT00731952	Non Small Cell ...	Velcade and Vor...	18 Years -	University of Virginia
FL-101 in Surgically Resectable Non-Small Cell Lung Cancer	NCT04758949	Non-Small Cell ...	FL-101 Nivolumab Placebo	18 Years -	Flame Biosciences

Spots Global Cancer Trial Database for surgically resectable