Status:
WITHDRAWN
FL-101 in Surgically Resectable Non-Small Cell Lung Cancer
Lead Sponsor:
Flame Biosciences
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
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 whethe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Additional Exclusion Criteria for Patients with Stage II and III Disease
- 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.
Key Trial Info
Start Date :
August 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04758949
Start Date
August 25 2021
End Date
December 22 2021
Last Update
January 11 2022
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