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

NCT04758949 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: FL-101-2001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

Surgically Resectable; NSCLC; Nivolumab; FL-101; Placebo

Outcome Measures

Primary Outcomes (1)

• Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0

  To evaluate the tolerability, incidence and severity of AEs and SAEs graded according to NCI CTCAE v5.0 of FL-101 as monotherapy and in combination with nivolumab.

  From time of first dose to 3 months after surgery

Secondary Outcomes (5)

• Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review.

  At time of surgery (around 6-8 weeks)

• Major Pathologic Response

  At time of surgery (around 6-8 weeks after first dose)

• Complete Pathologic Response

  At time of surgery (around 6-8 weeks after first dose)

• Objective Response Rate (ORR)

  At time of surgery (around 6-8 weeks after first dose)

• MRD measurement by ctDNA

  From time of first dose to 3 months after surgery

Other Outcomes (4)

• Plasma Concentration of FL-101

  From time of first dose up to 3 months after surgery

• Plasma IL-1β/IL-6 levels

  From time of first dose up to 3 months after surgery

• Serum hsCRP

  From enrollment up to 3 months after surgery

Study Arms (3)

FL-101 Monotherapy

EXPERIMENTAL

30 patients will receive FL-101 prior to surgery.

Drug: FL-101

FL-101 + Nivolumab

EXPERIMENTAL

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

Drug: FL-101; Drug: Nivolumab

Nivolumab + Placebo

ACTIVE COMPARATOR

30 patients will receive Nivolumab and placebo prior to surgery.

Drug: Nivolumab; Drug: Placebo

Interventions

FL-101 DRUG

200 mg administered intravenously every 2 weeks prior to surgery.

FL-101 + Nivolumab; FL-101 Monotherapy

Nivolumab DRUG

240 mg administered intravenously every 2 weeks prior to surgery.

FL-101 + Nivolumab; Nivolumab + Placebo

Placebo DRUG

200 mg administered intravenously every 2 weeks prior to surgery.

Nivolumab + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any prior exposure to chemotherapy, radiotherapy or systemic anti-cancer therapy (e.g., monoclonal antibody therapy) for lung cancer.
• 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
• 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.
• Tumors known to express driver mutations of the EGFR or ALK pathways.
• Known severe hypersensitivity (Grade ≥3) to FL-101, its active substance, or any of its excipients
• Known history of human immunodeficiency virus or active Hepatitis B or Hepatitis C infection
• Prior treatment with anti-PD-1, anti-CTLA-4, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
• 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
• Known severe hypersensitivity (Grade ≥3) to nivolumab or chemotherapy agents or to any of their excipients.

Sponsors & Collaborators

• Flame Biosciences: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Cassandra Choe-Juliak, MD

  Flame Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cohort 2 will be randomized. The investigator and participants will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 17, 2021
• Study Start: August 25, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12