Description:
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have
surgically resectable Non-Small Cell Lung Cancer.
Title
- Brief Title: FL-101 in Surgically Resectable Non-Small Cell Lung Cancer
- Official Title: A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients With Surgically Resectable Non-Small Cell Lung Cancer
Clinical Trial IDs
- ORG STUDY ID:
FL-101-2001
- NCT ID:
NCT04758949
Conditions
- Non-Small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
FL-101 | | FL-101 + Nivolumab |
Nivolumab | | FL-101 + Nivolumab |
Placebo | | Nivolumab + Placebo |
Purpose
Phase 2 trial to study FL-101 alone or in combination with nivolumab in patients who have
surgically resectable Non-Small Cell Lung Cancer.
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.
Trial Arms
Name | Type | Description | Interventions |
---|
FL-101 Monotherapy | Experimental | 30 patients will receive FL-101 prior to surgery. | |
FL-101 + Nivolumab | Experimental | 30 patients will receive FL-101 and Nivolumab prior to surgery. | |
Nivolumab + Placebo | Active Comparator | 30 patients will receive Nivolumab and placebo prior to surgery. | |
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
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 |
Safety Issue: | |
Description: | 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
Measure: | 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) |
Safety Issue: | |
Description: | 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 |
Measure: | Major Pathologic Response |
Time Frame: | At time of surgery (around 6-8 weeks after first dose) |
Safety Issue: | |
Description: | To determine major pathologic response (MPR), defined as ≤10 percent viable tumor |
Measure: | Complete Pathologic Response |
Time Frame: | At time of surgery (around 6-8 weeks after first dose) |
Safety Issue: | |
Description: | To estimate complete pathologic response (CPR), defined as the absence of residual invasive cancer in resected lung specimens and lymph nodes |
Measure: | Objective Response Rate (ORR) |
Time Frame: | At time of surgery (around 6-8 weeks after first dose) |
Safety Issue: | |
Description: | To estimate objective response rate (ORR) by RECIST 1.1 |
Measure: | MRD measurement by ctDNA |
Time Frame: | From time of first dose to 3 months after surgery |
Safety Issue: | |
Description: | To describe the time course of minimal residual disease (MRD) response by ctDNA and recurrence in correlation with clinical response |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Flame Biosciences |
Trial Keywords
- Surgically Resectable
- NSCLC
- Nivolumab
- FL-101
- Placebo
Last Updated
September 1, 2021