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Withdrawn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

First listed
Feb 17, 2021
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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