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

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.

Trial Description

Primary Outcome:

  • Number of patients with treatment related adverse events as assessed by NCI CTCAE v.5.0
Secondary Outcome:
  • Number of patients with treatment efficacy as assessed by pathological response (percentage of residual tumour) by independent pathology review.
  • Major Pathologic Response
  • Complete Pathologic Response
  • Objective Response Rate (ORR)
  • MRD measurement by ctDNA
A 2-Cohort, Phase 2, multicentre, 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-tumour activity when given alone prior to surgery, and if FL-101 improves the anti-tumour response when given in combination with nivolumab prior to surgery.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society