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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2021-12-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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FL-101 Monotherapy

30 patients will receive FL-101 prior to surgery.

Group Type EXPERIMENTAL

FL-101

Intervention Type DRUG

200 mg administered intravenously every 2 weeks prior to surgery.

FL-101 + Nivolumab

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

Group Type EXPERIMENTAL

FL-101

Intervention Type DRUG

200 mg administered intravenously every 2 weeks prior to surgery.

Nivolumab

Intervention Type DRUG

240 mg administered intravenously every 2 weeks prior to surgery.

Nivolumab + Placebo

30 patients will receive Nivolumab and placebo prior to surgery.

Group Type ACTIVE_COMPARATOR

Nivolumab

Intervention Type DRUG

240 mg administered intravenously every 2 weeks prior to surgery.

Placebo

Intervention Type DRUG

200 mg administered intravenously every 2 weeks prior to surgery.

Interventions

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FL-101

200 mg administered intravenously every 2 weeks prior to surgery.

Intervention Type DRUG

Nivolumab

240 mg administered intravenously every 2 weeks prior to surgery.

Intervention Type DRUG

Placebo

200 mg administered intravenously every 2 weeks prior to surgery.

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No