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

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ClinicalTrials.gov Identifier: NCT04758949
Recruitment Status : Withdrawn (Sponsor Decision)
First Posted : February 17, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Flame Biosciences

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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: FL-101 Drug: Nivolumab Drug: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Cohort 2 will be randomized. The investigator and participants will be masked.
Primary Purpose: Treatment
Official Title: A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
Actual Study Start Date : August 25, 2021
Actual Primary Completion Date : December 22, 2021
Actual Study Completion Date : December 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: FL-101 Monotherapy
30 patients will receive FL-101 prior to surgery.
Drug: FL-101
200 mg administered intravenously every 2 weeks prior to surgery.

Experimental: FL-101 + Nivolumab
30 patients will receive FL-101 and Nivolumab prior to surgery.
Drug: FL-101
200 mg administered intravenously every 2 weeks prior to surgery.

Drug: Nivolumab
240 mg administered intravenously every 2 weeks prior to surgery.

Active Comparator: Nivolumab + Placebo
30 patients will receive Nivolumab and placebo prior to surgery.
Drug: Nivolumab
240 mg administered intravenously every 2 weeks prior to surgery.

Drug: Placebo
200 mg administered intravenously every 2 weeks prior to surgery.




Primary Outcome Measures :
  1. 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 ]
    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.


Secondary Outcome Measures :
  1. Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumor) by independent pathology review. [ Time Frame: At time of surgery (around 6-8 weeks) ]

    Cohort 1: To evaluate the activity of FL-101 neoadjuvant monotherapy in patients with Stage IA3 or IB NSCLC

    Cohort 2: To evaluate the effect of FL-101 in combination with nivolumab compared to nivolumab plus placebo in neoadjuvant therapy in patients with Stage II-IIIA NSCLC


  2. Major Pathologic Response [ Time Frame: At time of surgery (around 6-8 weeks after first dose) ]
    To determine major pathologic response (MPR), defined as ≤10 percent viable tumor

  3. Complete Pathologic Response [ Time Frame: At time of surgery (around 6-8 weeks after first dose) ]
    To estimate complete pathologic response (CPR), defined as the absence of residual invasive cancer in resected lung specimens and lymph nodes

  4. Objective Response Rate (ORR) [ Time Frame: At time of surgery (around 6-8 weeks after first dose) ]
    To estimate objective response rate (ORR) by RECIST 1.1

  5. MRD measurement by ctDNA [ Time Frame: From time of first dose to 3 months after surgery ]
    To describe the time course of minimal residual disease (MRD) response by ctDNA and recurrence in correlation with clinical response


Other Outcome Measures:
  1. Plasma Concentration of FL-101 [ Time Frame: From time of first dose up to 3 months after surgery ]
    To evaluate the pharmacokinetics of FL-101 in patients with NSCLC

  2. Plasma IL-1β/IL-6 levels [ Time Frame: From time of first dose up to 3 months after surgery ]
    To evaluate the effect of FL-101 on pharmacodynamic biomarkers

  3. Serum hsCRP [ Time Frame: From enrollment up to 3 months after surgery ]
    To evaluate the effect of FL-101 on pharmacodynamic biomarkers

  4. Prevalence and incidence of Anti-FL-101 antibodies [ Time Frame: From time of first dose up to 3 months after surgery ]
    To evaluate possible immunogenicity of FL-101



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758949


Sponsors and Collaborators
Flame Biosciences
Investigators
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Study Director: Cassandra Choe-Juliak, MD Flame Biosciences
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Responsible Party: Flame Biosciences
ClinicalTrials.gov Identifier: NCT04758949    
Other Study ID Numbers: FL-101-2001
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Flame Biosciences:
Surgically Resectable
NSCLC
Nivolumab
FL-101
Placebo
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action