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LUME-Lung 3. A Phase I/II study of continuous oral treatment with BIBF 1120 added to standard gemcitabine/cisplatin therapy in first line NSCLC patients with squamous cell histology.

Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…

A Two-cohort, Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy and in combination with nivolumabTimepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To…

A randomized, phase 3 trial with anti-PD-1 monoclonal antibody pembrolizumab (MK-3475) versus placebo for patients with early stage NSCLC after resection and completion of standard adjuvant therapy (PEARLS)

This study has been transitioned to CTIS with ID 2023-509137-39-00 check the CTIS register for the current data. Primary/dualco-primary. To prospectively investigate whether adjuvant treatment with pembrolizumab after completion of radical surgery (…

A Two-Cohort Phase 2 Study of FL-101 as Neoadjuvant Therapy in Patients with Surgically Resectable Non-Small Cell Lung Cancer

Primary Objective:To evaluate the safety and tolerability of FL-101 as monotherapy.Timepoint of evaluation of primary objective: From first dose to 3 months after surgerySecondary Efficacy Objectives1. Cohort 1: To evaluate the activity of FL-101…