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

Sponsor
Flame Biosciences
Study ID
NCT04758949
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FL-101 — DRUG
    200 mg administered intravenously every 2 weeks prior to surgery.
  • Nivolumab — DRUG
    240 mg administered intravenously every 2 weeks prior to surgery.
  • Placebo — DRUG
    200 mg administered intravenously every 2 weeks prior to surgery.

Study Details

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

Key Dates

Start date
Aug 25, 2021
Status verified
Dec 2021
Primary completion
Dec 22, 2021
Completion
Dec 22, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FL-101 Monotherapy
    30 patients will receive FL-101 prior to surgery.
  • Experimental: FL-101 + Nivolumab
    30 patients will receive FL-101 and Nivolumab prior to surgery.
  • Active Comparator: Nivolumab + Placebo
    30 patients will receive Nivolumab and placebo prior to surgery.

Primary Outcome Measure

Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0 [ Time Frame: From time of first dose to 3 months after surgery ]

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