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

Flame Biosciences

Status and phase: Withdrawn; Phase 2

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Nivolumab; Drug: Placebo; Drug: FL-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT04758949

FL-101-2001

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups

FL-101 Monotherapy

Experimental group

Description:

30 patients will receive FL-101 prior to surgery.

Treatment:

Drug: FL-101

FL-101 + Nivolumab

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: FL-101

Nivolumab + Placebo

Active Comparator group

Description:

30 patients will receive Nivolumab and placebo prior to surgery.

Treatment:

Drug: Nivolumab

Drug: Placebo