Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01964157

An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement

Non-small Cell Lung Cancer (NSCLC) Clinical Trial

Clinical Trial Summary

ROS1 is a receptor tyrosine kinase with constitutive kinase activity. ROS1 was previously discovered in cell lines where ROS1 fused with other proteins to act as a driver oncogene. In 2007, Rikova et al reported ROS1 fusion as driver mutations in NSCLC cell line (HCC78; SLC34A2-ROS1) and NSCLC patient (CD74-ROS1). Li et al also found about 1% of samples harboring CD74-ROS1 fusion in 202 resected lung adenocarcinomas from never smokers. The incidence was as high as 10% in East Asian population. Currently there are now at least 13 ROS1 fusion variants involving 8 fusion partners (CD74-, SLC34A2-, FIG-, TPM3-, SDC4-, LRIG3-, ERZ-, KDERL2-) identified in ROS1 positive NSCLC. LDK378 is an orally highly selective and potent ALK kinase inhibitor. In preclinical studies, LDK378 has much lower IC50 values than crizotinib in cell lines engineered to express ROS1 rearrangement (0.15 nM versus 3 nM) and is approximately 20-fold more potent. LDK378 is a potent inhibitor of tumor growth in rodent models of both ALCL and NSCLC. We suggest a phase II trial of LDK378 in advanced non-small cell lung cancer patients with ROS1 rearrangement. The aim of current trial is to evaluate the antitumor efficacy and safety profile of LDK378 and to identify biomarker to predict the tumor response to LDK378.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01964157
Study type Interventional
Source Yonsei University
Contact Byung Chul Cho, MD
Phone 82-2-2228-0880
Email CBC1971@yuhs.ac
Status Recruiting
Phase Phase 2
Start date September 1, 2013
Completion date December 2019
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06040541 - Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors Phase 1
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT03667820 - Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC Phase 2
Completed NCT02025114 - Selumetinib in Combination With Gefitinib in NSCLC Patients Phase 1/Phase 2
Recruiting NCT01994057 - A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
Completed NCT01438307 - Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer Phase 2
Completed NCT01193959 - Pemetrexed in Advanced Non-small Cell Lung Cancer
Recruiting NCT01028729 - A Study of Endostar Combined With Chemotherapy Followed by Endostar Maintenance Therapy to Treat Advanced Non-small Cell Lung Cancer (NSCLC) Phase 4
Completed NCT00770588 - Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) Phase 4
Recruiting NCT05462717 - Dose Escalation and Dose Expansion Study of RMC-6291 Monotherapy in Subjects With Advanced KRASG12C Mutant Solid Tumors Phase 1
Completed NCT01951157 - A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients Phase 2
Active, not recruiting NCT04026412 - A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery Phase 3
Recruiting NCT05585320 - A Phase 1/2a Study of IMM-1-104 in Participants With Previously Treated, RAS-Mutant, Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03260491 - U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer Phase 1
Completed NCT05207423 - A Chart Review Study of Adults With Advanced NSCLC
Terminated NCT02608528 - Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
Completed NCT01463423 - Individualized Lung Tumor Stereotactic Ablative Radiotherapy (iSABR) N/A
Recruiting NCT02927340 - A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions Phase 2
Recruiting NCT02521051 - Phase I/II Trial of Alectinib and Bevacizumab in Patients With Advanced, Anaplastic Lymphoma Kinase (ALK)-Positive, Non-Small Cell Lung Cancer Phase 1/Phase 2
Completed NCT02403193 - Trial of PBF-509 and PDR001 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Phase 1