Clinical trial NCT04758949: FL-101 in Surgically Resectable Non-Small Cell Lung Cancer
Official title: A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Surgically Resectable
NSCLC
Nivolumab
FL-101
Placebo
Lead sponsor: Flame Biosciences
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have surgically resectable Non-Small Cell Lung Cancer.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Previously untreated and pathologically confirmed, surgically resectable Stage IA3, IB, II, or IIIA NSCLC of squamous or non-squamous histology.
2. ≥1 radiologically measurable tumor \>2cm in diameter.
3. Smoking history ≥10 pack years.
4. Available tissue block for analysis from a core needle biopsy(or similar sample)
5. High-sensitivity C-reactive protein (hsCRP) level ≥2 mg/L

Exclusion Criteria:

1. Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
2. Malignancies other than NSCLC within 2 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and with expected curative outcome
3. Currently participating in, or has participated in, a trial of an investigational agent within 4 weeks prior to the first dose of study treatment or 5 half-lives, whichever is longer and with recovery of clinically significant toxicities from that therapy.
4. Tumors known to express driver mutations of the EGFR or ALK pathways.
5. Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
6. Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C infection

Additional Exclusion Criteria for Patients with Stage II and III Disease

1. Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
2. Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[anti-TNF\] agents) within 2 weeks prior to Cycle 1, Day 1
3. Known severe hypersensitivity (Grade ≥3) to nivolumab or chemotherapy agents or to any of their excipients.

Primary outcomes:
measure: Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
timeFrame: From time of first dose to 3 months after surgery
Secondary outcomes:
measure: Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.
timeFrame: At time of surgery (around 6-8 weeks)
measure: Major Pathologic Response
timeFrame: At time of surgery (around 6-8 weeks after first dose)
measure: Complete Pathologic Response
timeFrame: At time of surgery (around 6-8 weeks after first dose)
measure: Objective Response Rate (ORR)
timeFrame: At time of surgery (around 6-8 weeks after first dose)
measure: MRD measurement by ctDNA
timeFrame: From time of first dose to 3 months after surgery
Other outcomes:
measure: Plasma Concentration of FL-101
timeFrame: From time of first dose up to 3 months after surgery
measure: Plasma IL-1β/IL-6 levels
timeFrame: From time of first dose up to 3 months after surgery
measure: Serum hsCRP
timeFrame: From enrollment up to 3 months after surgery
measure: Prevalence and incidence of Anti-FL-101 antibodies
timeFrame: From time of first dose up to 3 months after surgery
Locations:
Study officials:
affiliation: Flame Biosciences
name: Cassandra Choe-Juliak, MD
role: STUDY_DIRECTOR
References: