Molecular Determinants of Acquired Clinical Resistance to Crizotinib in Non-small Cell Lung Cancer Harboring a Translocation or Inversion Event Involving the ALK Gene Locus

Plain-language summary

This study investigates the molecular causes of acquired (later-developing) resistance to the drug Crizotinib in patients with non-small cell lung cancer carrying an ALK gene alteration (translocation/inversion). It included patients who progressed after responding to Crizotinib and were amenable to biopsy. It is an observational (non-phase) study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Memorial Sloan Kettering Cancer Center

Intervention

obtain tissue specimens

Start date

2/8/2011

Estimated completion

1/5/2021

Countries

United States

Related genes

Locations

• New York, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* ≥18 years of age
* Histologically proven diagnosis of NSCLC at MSKCC Tumor positive for a translocation or inversion event involving the ALK gene locus
* Clinical response to treatment with crizotinib as defined by either:

Radiographic partial or complete response defined by RECIST or WHO

OR:

Radiographic stable disease for at least 8 weeks

* Radiographic progression of disease amenable to biopsy while on treatment with crizotinib as defined by RECIST or WHO
* Signed informed consent

Exclusion Criteria:

* Deemed by their treating physician to be medically unfit for biopsy
* Women who are pregnant or breast-feeding