Clinical trials: ALK-positive NSCLC
ALK-POSITIVE NSCLC
The Absorption, Metabolism and Excretion of [14C]Ensartinib in Human
This is a single-center, open-label, single-dose phase I study to investigate the absorption, metabolism and excretion of [14C] Ensartinib in healthy Chinese male subjects.
- Trial name
- NCT03804541
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
ALK-positive NSCLC
Study of TQ-B3139 Versus Crizotinib in the First Line Treatment of Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC)
To evaluate the efficacy and safety of TQ-B3139 versus crizotinib in subjects with ALK-positive NSCLC that have received one chemotherapy regimen and have not received ALK inhibitor.
- Trial name
- NCT04009317
- Testing
- TQ-B3139, Crizotinib
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Neoplasms
A Rollover Study of Alectinib in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive or Rearranged During Transfection (RET)-Positive Cancer
The purpose of this study is to provide continued treatment with alectinib or crizotinib as applicable to participants with ALK- or RET positive cancer who were previously enrolled in any Roche-sponsored alectinib study and who…
- Trial name
- NCT03194893
- Testing
- Alectinib, Crizotinib
- Where
- 29 sites in United States, France and 7 more
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
To compare the efficacy and safety of ceritinib with standard first-line chemotherapy (pemetrexed plus cisplatin or carboplatin) in patients with stage IIIB (not candidates for definitive multimodality therapy) or stage IV…
- Trial name
- NCT01828099
- Testing
- Ceritinib, Pemetrexed, Cisplatin
- Where
- 167 sites in Argentina, Australia and 27 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small-Cell Lung Cancer, NSCLC
Lorlatinib Continuation Study
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that…
- Trial name
- NCT05144997
- Testing
- Lorlatinib
- Where
- 27 sites in United States, China and 6 more
- Volunteers
- 76 people
- Sponsor
- Pfizer
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
Lung Cancer, Nonsmall Cell, Brain Metastases
X-396 (Ensartinib) Capsules in ALK-Positive NSCLC Patients With Brain Metastases
To assess efficacy and safety of oral X-396 (Ensartinib) capsule in Chinese ALK-positive NSCLC patients with brain metastases, eligible patients will be enrolled with objective responses being primary outcome measures.
- Trial name
- NCT04415320
- Testing
- X-396(Ensartinib)
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
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.
Non-small Cell Lung Cancer (NSCLC)
A Study of Brigatinib as Preferred First Therapy for Adults With Non-Small Cell Lung Cancer (NSCLC) ENTIRETY
This is a study of brigatinib in adults with Non-Small Cell Lung Cancer (NSCLC). The main aim of this study is to learn about the time period in which the condition does not worsen after the participant has received brigatinib.
- Trial name
- ENTIRETY (NCT05735327)
- Testing
- No intervention
- Where
- 12 sites in Poland
- Volunteers
- 50 people
- Sponsor
- Takeda
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
Anaplastic Lymphoma Kinase-positive, Carcinoma Non-small-cell Lung
A Study to Determine Progression-free Survival (PFS) and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) Non-Small Cell Lung Cancer (NSCLC) Treated With Anaplastic Lymphoma Kinase (ALK) Inhibitors
The primary purpose of this study is to determine the differences in PFS for participants who have been receiving brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants receiving alectinib, ceritinib…
- Trial name
- NCT03546894
- Testing
- Brigatinib, Alectinib, Ceritinib
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Takeda
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