A Phase I/IIA Study of CLN-081 in People with Non-Small Cell Lung Cancer


Full Title

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


Some non-small cell lung cancers (NSCLC) have a unique type of genetic mutation called an “EGFR exon 20 insertion,” but there are no FDA-approved targeted therapies for this mutation. CLN-081 is an investigational drug that targets EGFR exon 20 mutations and is designed to slow down or stop abnormal cell growth. The action of this drug may stabilize or shrink tumors.

In this study, researchers want to find the highest dose of CLN-081 that can be given safely in people with EGFR-mutant, exon 20-positive NSCLC that has continued to grow despite prior treatment, and to see how well patients respond to the treatment. CLN-081 is taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or metastatic NSCLC with an EGFR exon 20 insertion.
  • Patients’ cancers must persist following previous treatment with a platinum-containing drug.
  • An acceptable amount of time must pass between the completion of prior therapy and entry into the study (1-2 weeks, depending on the treatment).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Helena Yu at 646-608-3912.




Phase I/II (phases 1 and 2 combined)

Disease Status

Relapsed or Refractory



ClinicalTrials.gov ID