Clinical trials: ALK-positive Advanced NSCLC
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
Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic…
- Trial name
- ALKAZAR (NCT06765109)
- Testing
- Neladalkib (NVL-655), Alectinib
- Where
- 159 sites in United States, Argentina and 27 more
- Volunteers
- 450 people
- Sponsor
- Nuvalent Inc.
Non-Small Cell Lung Cancer
LDK378 Versus Chemotherapy in ALK Rearranged (ALK Positive) Patients Previously Treated With Chemotherapy (Platinum Doublet) and Crizotinib
The primary purpose of the study was to compare the antitumor activity of LDK378 vs. chemotherapy in patients previously treated with chemotherapy (platinum doublet) and crizotinib.
- Trial name
- NCT01828112
- Testing
- Ceritinib, Pemetrexed, Docetaxel
- Where
- 97 sites in United States, Belgium and 18 more
- Volunteers
- 231 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
LDK378 in Adult Chinese Patients With ALK-rearranged (ALK-positive) Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
A single-Arm, open-label, multi-center, phase I/II study in which the pharmacokinetics, safety, tolerability and efficacy of LDK378 will be assessed in adult Chinese patients with locally advanced or metastatic NSCLC harboring a…
- Trial name
- NCT02040870
- Testing
- LDK378
- Where
- 15 sites in China
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals
NSCLC
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib
This study aims to characterize the clinical management and outcomes of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with alectinib in…
- Trial name
- ReAlec (NCT04764188)
- Testing
- Alectinib
- Where
- 116 sites in Argentina, Australia and 23 more
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche
ALK-positive Advanced NSCLC
A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib
The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in…
- Trial name
- ALTA-2 (NCT03535740)
- Testing
- Brigatinib
- Where
- 80 sites in United States, Australia and 13 more
- Volunteers
- 103 people
- Sponsor
- Ariad Pharmaceuticals
NSCLC
Post-Market Surveillance Study of ALK-Positive Advanced NSCLC Participants Treated With Iruplinalkib
The goal of this observational study is to evaluate the safety and efficacy of participants diagnosed with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) who are being treated with…
- Trial name
- NCT06644495
- Volunteers
- 1,000 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Non-small Cell Lung Cancer, Lung Cancer
ALTA-1L Study: A Study of Brigatinib Versus Crizotinib in Anaplastic Lymphoma Kinase Positive (ALK+) Advanced Non-small Cell Lung Cancer (NSCLC) Participants
The purpose of the study is to compare the efficacy of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic non-small cell lung cancer (NSCLC) participants naive to ALK inhibitors, as evidenced by…
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
- Trial name
- ALTA-1L (NCT02737501)
- Testing
- Brigatinib, Crizotinib
- Where
- 91 sites in United States, Australia and 17 more
- Volunteers
- 275 people
- Sponsor
- Ariad Pharmaceuticals
Non-small Cell Lung Cancer
Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Participants Previously Treated With Platinum-Based Chemotherapy and Crizotinib
This randomized active-controlled multicenter Phase III open-label study will evaluate and compare between treatment groups the efficacy of alectinib versus chemotherapy in participants with ALK-positive advanced NSCLC who were…
- Trial name
- NCT02604342
- Testing
- Alectinib, Docetaxel, Pemetrexed
- Where
- 54 sites in Belgium, Bulgaria and 13 more
- Volunteers
- 119 people
- Sponsor
- Hoffmann-La Roche
Advanced Cancer, Advanced Solid Tumor
A Phase I/II Clinical Study of SAF-189s in Non-small Cell Lung Cancer (NSCLC) Patients
The study comprises two phases: phase I dose escalation (including PK run-in period and treatment period) and phase II study.
- Conditions
- Advanced Cancer, Advanced Solid Tumor, Lung Cancer, Nonsmall Cell
- Trial name
- NCT04237805
- Testing
- SAF-189s
- Where
- 41 sites in China
- Volunteers
- 280 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
ALK or ROS1-positive NSCLC
Long Term Safety Observation of Crizotinib in Chinese NSCLC Population
This study is to allow access to crizotinib who were treated in previous Pfizer-sponsored studies in China.
- Trial name
- NCT03672643
- Testing
- Crizotinib
- Where
- 14 sites in China
- Volunteers
- 41 people
- Sponsor
- Pfizer
Advanced Solid Tumors
A Study of TAS-116 in Patients With Solid Tumors
A First-in-Human (FIH) study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then. The study consists of a dose escalation phase and a dose expansion phase.
- Trial name
- NCT02965885
- Testing
- TAS-116
- Where
- 12 sites in United States, Italy and 1 more
- Volunteers
- 31 people
- Sponsor
- Taiho Oncology, Inc.
ALK-positive Advanced NSCLC
Phase 2 Study of Brigatinib in Japanese Participants With Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate efficacy and safety of brigatinib in Japanese participants with anaplastic lymphoma kinase (ALK)-positive NSCLC.
- Trial name
- NCT03410108
- Testing
- Brigatinib
- Where
- 33 sites in Japan
- Volunteers
- 104 people
- Sponsor
- Takeda
Non-small Cell Lung Cancer
Safety And Efficacy Of Crizotinib (Regulatory Post Marketing Commitment Plan)
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors…
- Trial name
- NCT01597258
- Testing
- Crizotinib (Xalkori)
- Volunteers
- 2,029 people
- Sponsor
- Pfizer
ALK-positive Advanced NSCLC
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and anti-tumor activity of the combination.
- Trial name
- NCT02511184
- Testing
- Crizotinib, Pembrolizumab
- Where
- 15 sites in United States
- Volunteers
- 9 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer
Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified adverse events and any other…
- Trial name
- NCT03271554
- Testing
- Alectinib
- Where
- 37 sites in South Korea
- Volunteers
- 355 people
- Sponsor
- Hoffmann-La Roche
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations
Phase 1 and 2 trial to study the safety, pharmacokinetics, pharmacodynamics, patient reported outcomes and efficacy of PF-06463922 in ALK + advanced non-small cell lung cancer patients and ROS1+ advanced non small cell lung…
- Trial name
- NCT01970865
- Testing
- PF-06463922, Crizotinib
- Where
- 77 sites in United States, Australia and 12 more
- Volunteers
- 364 people
- Sponsor
- Pfizer
ALK-positive Advanced Tumors
A Phase I, Multi-center, Open Label, Drug-drug Interaction Study to Assess the Effect of Ceritinib on the Pharmacokinetics of Warfarin and Midazolam in Patients With ALK-positive Advanced Tumors
The purpose of this study was to evaluate the potential inhibitory effects of ceritinib on the CYP3A4- and CYP2C9-mediated metabolism of the probe drugs midazolam and warfarin, respectively, when administered simultaneously as a…
- Trial name
- NCT02422589
- Testing
- ceritinib, warfarin, midazolam
- Where
- 11 sites in United States, Denmark and 2 more
- Volunteers
- 33 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07140016
- Testing
- gilteritinib
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Non-small Cell Lung Cancer
A Study to Evaluate and Compare the Efficacy and Safety of XZP-3621 Versus Crizotinib
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of XZP-3621 versus crizotinib and to evaluate the pharmacokinetics of XZP-3621 in Chinese participants with treatment-naive…
- Trial name
- NCT05204628
- Testing
- XZP-3621, Crizotinib
- Where
- China
- Volunteers
- 238 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.