Clinical trials: ROS1 Gene Rearrangement
Non-small Cell Lung Cancer (NSCLC)
An Open-label, Multicenter, Phase II Study of LDK378 in Patients With Non-small Cell Lung Cancer Harboring ROS1 Rearrangement
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.
- Trial name
- NCT01964157
- Testing
- LDK378
- Where
- South Korea
- Volunteers
- 32 people
- Sponsor
- Yonsei University
Solid Tumors, CNS Tumors
Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options
This is an open-label, Phase 1/2 multicenter dose escalation study in pediatric patients with relapsed or refractory extracranial solid tumors (Phase 1), with additional expansion cohorts (Phase 2) in patients with primary brain…
- Trial name
- STARTRK-NG (NCT02650401)
- Testing
- Entrectinib
- Where
- 26 sites in United States, Canada and 7 more
- Volunteers
- 69 people
- Sponsor
- Hoffmann-La Roche
ALK Positive, Locally Advanced Malignant Solid Neoplasm
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other…
- Conditions
- ALK Positive, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, ROS1 Gene Rearrangement
- Trial name
- NCT02321501
- Testing
- Ceritinib, Everolimus, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Nsclc, EGFR Activating Mutation
Pembrolizumab, Lenvatinib and Chemotherapy After TKIs in NSCLC
Adding chemotherapy or anti-VEGF to immunotherapy is an emerging strategy to enhance the efficacy of immunotherapy in many cancers.
- Conditions
- Nsclc, EGFR Activating Mutation, EGF-R Positive Non-Small Cell Lung Cancer, ALK Gene Rearrangement Positive
- Trial name
- NCT04989322
- Testing
- Pembrolizumab, Lenvatinib, Pemetrexed
- Where
- Hong Kong
- Volunteers
- 46 people
- Sponsor
- Dr Joanne CHIU
Non-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Study of Crizotinib for ROS1 and MET Activated Lung Cancer
This is a phase 2 study of a drug called crizotinib in people with metastatic (the cancer has spread to other parts of the body) non-small cell lung cancer with a mutation (change) in genes called ROS1 or MET.
- Conditions
- Non-squamous Non-small-cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, ROS1 Gene Rearrangement, MET Activating Mutation
- Trial name
- NCT04084717
- Testing
- Crizotinib
- Where
- Canada
- Volunteers
- 33 people
- Sponsor
- University Health Network, Toronto
Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
To determine the effect of a special preparation of cells, called tumor-infiltrating lymphocytes (TIL) stimulated with CD40L, when given with the drug nivolumab, for patients with EGFR, ALK, ROS1, or HER2-genomically altered lung…
- Conditions
- Non Small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer, Recurrent Non Small Cell Lung Cancer
- Trial name
- NCT05681780
- Testing
- Tumor-infiltrating Lymphocytes (TIL), Nivolumab, Cyclophosphamide
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Lung Cancer
APatinib Plus Chemotherapy vErsus Chemotherapy As First-line Treatment for Advanced NSCLC
The purpose of this study is to studying the addition of apatinib with chemotherapy to investigate the efficacy and safety of apatinib in combination with chemotherapy in patients with advanced NSCLC.
- Trial name
- APPEAL (NCT03164694)
- Testing
- Apatinib, Pemetrexed, Carboplatin
- Where
- China
- Sponsor
- Sun Yat-sen University
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma
- Trial name
- PROFILE 1001 (NCT00585195)
- Testing
- PF-02341066, Rifampin, Itraconazole
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 596 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer, ROS1 Gene Rearrangement
Real-world Observational Study of Targeted Therapy in Patients With Advanced ROS1-positive NSCLC
The purpose of this project is to conduct an observational study on the efficacy and safety of entrectinib in real-world patients with ROS1-positive NSCLC who have received entrectinib treatment, while exploring the mechanism of…
- Conditions
- Non-Small Cell Lung Cancer, ROS1 Gene Rearrangement, Resistance, Targeted Therapy
- Trial name
- NCT06694129
- Testing
- Entrectinib
- Volunteers
- 40 people
- Sponsor
- National Cancer Center, China
NSCLC, Crizotinib
Descriptive Observational Study ALK-2016-CPHG
Descriptive Observational Study. Characteristics Of ALK-positive and ROS1-positive Adults Patients Non-Small Cell Lung Cancer (NSCLC) Treated With Crizotinib Within General Hospitals
- Conditions
- NSCLC, Crizotinib, ALK Gene Rearrangement or ROS1 Gene Rearrangement
- Trial name
- ALK2016CPHG (NCT03718117)
- Where
- 26 sites in France
- Volunteers
- 73 people
- Sponsor
- Pfizer
Carcinoma, Non-Small-Cell Lung
A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC).
- Trial name
- NCT04603807
- Testing
- Entrectinib, Crizotinib
- Where
- 61 sites in Brazil, China and 16 more
- Volunteers
- 217 people
- Sponsor
- Hoffmann-La Roche
Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive
Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the…
- Conditions
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- Trial name
- LORLATU (NCT03727477)
- Where
- 30 sites in France
- Volunteers
- 291 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Lung Cancer, ROS1 Gene Rearrangement
X-396 Capsule in Advanced NSCLC Patients With ROS1 Gene Rearrangement
To assess treatment effectiveness and safety of oral X-396 capsule (Ensartinib) administered to Chinese patients with Advanced Non-Small Cell Lung Cancer (NSCLC) that is confirmed to be positive for a c-ROS Oncogene (ROS1)…
- Trial name
- NCT03608007
- Testing
- X-396 Capsule
- Where
- China
- Volunteers
- 69 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
Advanced Solid Tumor, Metastatic Solid Tumor
A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastatin in Patients With Advanced Solid Tumors
This is a Phase 1 study to evaluate the potential drug-drug interaction (DDI) effect of repotrectinib on certain drug transporters in patients with advanced cancer.
- Trial name
- NCT05828303
- Testing
- TPX-0005, Metformin Hydrochloride, Digoxin
- Where
- 33 sites in United States, Australia and 4 more
- Sponsor
- Turning Point Therapeutics, Inc.
Protein Kinase Inhibitors, Other Protocol Specified Criteria
Phase I Study of JYP0322 in ROS1 Fusion-Positive Solid Tumors
An open, non-randomized, multicenter, single-arm dose-escalation design, phase 1 trial to study the safety, tolerability, pharmacokinetics and efficacy of JYP0322 in patients with ROS1+ locally advanced/metastatic solid tumors .
- Conditions
- Protein Kinase Inhibitors, Other Protocol Specified Criteria, Lung Neoplasms, Brain Neoplasms
- Trial name
- JYP0322 (NCT06128148)
- Testing
- JYP0322 50 mg qd, JYP0322 100 mg qd, JYP0322 200 mg qd
- Where
- China
- Volunteers
- 101 people
- Sponsor
- Guangzhou JOYO Pharma Co., Ltd
Non-Small Cell Lung Cancer
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)
Phase 2 Platform Study in Patients with Advanced Non-Small Lung Cancer who progressed on First-Line Osimertinib Therapy. This study is modular in design, allowing evaluation of the efficacy, safety and tolerability of multiple…
- Trial name
- ORCHARD (NCT03944772)
- Testing
- Osimertinib, Savolitinib, Gefitinib
- Where
- 47 sites in United States, Denmark and 7 more
- Volunteers
- 247 people
- Sponsor
- AstraZeneca
ALK Gene Rearrangement, Lung Non-Small Cell Carcinoma
Brigatinib and Binimetinib in Treating Patients With Stage IIIB-IV ALK or ROS1-Rearranged Non-small Cell Lung Cancer
This phase I trial studies the side effects and best dose of brigatinib and binimetinib in treating patients with stage IIIB-IV non-small cell lung cancer and a type of gene mutation called a rearrangement in the ALK or ROS1…
- Conditions
- ALK Gene Rearrangement, Lung Non-Small Cell Carcinoma, Progressive Disease, ROS1 Gene Rearrangement
- Trial name
- NCT04005144
- Testing
- Binimetinib, Brigatinib
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of California, San Francisco
NSCLC, Brain Metastases
Repotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain Metastasis
REPOSE is a phase II clinical trial exploring the safety and efficacy of repotrectinib in patients with non-small cell lung cancer (NSCLC) characterized by the presence of brain metastasis (BM) and whose tumors have mutated ROS…
- Conditions
- NSCLC, Brain Metastases, ROS1 Gene Rearrangement
- Trial name
- REPOSE (NCT06315010)
- Testing
- Repotrectinib
- Where
- 17 sites in Austria, Germany and 1 more
- Volunteers
- 20 people
- Sponsor
- MedSIR
Breast Cancer, Cholangiocarcinoma
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)
This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion.
- Conditions
- Breast Cancer, Cholangiocarcinoma, Colorectal Cancer, Head and Neck Neoplasms
- Trial name
- STARTRK-2 (NCT02568267)
- Testing
- Entrectinib
- Where
- 120 sites in United States, Australia and 14 more
- Volunteers
- 534 people
- Sponsor
- Hoffmann-La Roche
Cancer, Cancer Metastatic
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers.
- Conditions
- Cancer, Cancer Metastatic, NTRK Gene Fusion Overexpression, NTRK Family Gene Mutation
- Trial name
- TRacKING (NCT04921553)
- Testing
- Data collection and quality of life questionnaire
- Where
- 41 sites in Austria, Czechia and 9 more
- Volunteers
- 500 people
- Sponsor
- Centre Leon Berard