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NCI-2019-07236

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients with Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy


This Phase 1/2 open-label, multi-center trial aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of CLN-081 in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have previously undergone chemotherapy. The research aims to understand how CLN-081 works, its effects on tumors and the body, and if it can help shrink tumors and improve outcomes for patients who have not responded well to previous chemotherapy.

Metastatic: cancer that has spread from its original location or organ to other parts of the body.

Advanced: Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Phase 1/2: A study that assesses the safety, effectiveness, and how well the treatment works

EGFR: Epidermal Growth Factor Receptor (EGFR) is on the surface of cells and helps them grow and divide. In cancer, EGFR is like a switch that gets stuck in the "on" position, making cells grow and divide too much.

For more information about the trial, click the link below:

Clinical Trial Site: Columbia


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