Clinical trials: ALK-positive Non-small-cell Lung Cancer
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
Carcinoma, Non-Small-Cell Lung
Real World Clinical Outcomes of Resected ALK-Positive Early Stage NSCLC Patients Treated With Alectinib as Adjuvant Therapy
This study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage II-IIIB anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) adult…
- Trial name
- NCT06862869
- Testing
- Alectinib
- Where
- 44 sites in China
- Volunteers
- 800 people
- Sponsor
- Hoffmann-La Roche
ALK-positive Non-small-cell Lung Cancer
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a…
- Trial name
- NCT04979988
- Testing
- Lortlatinib
- Where
- 16 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Pfizer
Non Small Cell Lung Cancer, ALK-positive Non-small Cell Lung Cancer (NSCLC)
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid Tumors
The Expanded Access Program will provide an alternate mechanism for patients, who lack satisfactory therapeutic alternatives and cannot participate in a neladalkib clinical trial, to access investigational neladalkib.
- Trial name
- NVL-655-EAP (NCT06834074)
- Testing
- NVL-655
- Where
- 50 sites in United States, Australia and 10 more
- Sponsor
- Nuvalent Inc.
Advanced Solid Tumors, Non-small Cell Lung Cancer
Phase 1/2 Study of X-396, an Oral ALK Inhibitor, in Patients With ALK-positive Non-Small Cell Lung Cancer
This is the first human study to use X-396 (ensartinib), a drug being developed for treatment of advanced cancers. The initial purpose of the study is to determine the largest amount of X-396 that can be safely given to humans…
- Trial name
- NCT01625234
- Testing
- Phase I: X-396 (ensartinib), Phase II: X-396 (ensartinib)
- Where
- 14 sites in United States
- Volunteers
- 131 people
- Sponsor
- Xcovery Holdings, Inc.
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
Carcinoma, Advanced ALK+ or ROS1+Non-Small-Cell Lung, Neoplasm, Advanced ALK+ or ROS1+Solid Tumors
A Phase 1 Drug-Drug Interaction Study Between Brigatinib and the CYP3A Substrate, Midazolam, in Participants With ALK-Positive or ROS1-Positive Solid Tumors
The purpose of this study is to characterize the effect of repeat-dose administration of brigatinib 180 milligram (mg) once daily (QD) on the single-dose pharmacokinetics (PK) of midazolam.
- Trial name
- NCT03420742
- Testing
- Midazolam, Brigatinib
- Where
- 14 sites in France, Italy and 2 more
- Volunteers
- 24 people
- Sponsor
- Takeda
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
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
Non-Small Cell Lung Cancer
Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state…
- Trial name
- NCT02299505
- Testing
- ceritinib
- Where
- 73 sites in United States, Australia and 22 more
- Volunteers
- 306 people
- Sponsor
- Novartis Pharmaceuticals
Non-Small Cell Lung Cancer
A Clinical Study Testing The Safety And Efficacy Of Crizotinib In East Asian Patients With Anaplastic Lymphoma Kinase (ALK) Positive Advanced Non-Small Cell Lung Cancer
This is an open-label multi-center Phase 2 efficacy and safety study of crizotinib in East Asian patients with advanced Non-Squamous NSCLC harboring a translocation or inversion event involving the ALK gene locus who have…
- Trial name
- NCT01500824
- Testing
- Crizotinib
- Sponsor
- Pfizer
Non Small Cell Lung Cancer
A Study of Ganetespib in Subjects With ALK-Positive Non-Small-Cell Lung Cancer (NSCLC)
Phase 2 study of subjects with ALK positive, advanced NSCLC who have failed up to 3 prior therapies. The study will take place globally at multiple study centers.
- Trial name
- CHIARA (NCT01562015)
- Testing
- Ganetespib
- Where
- 5 sites in United States, Canada
- Volunteers
- 12 people
- Sponsor
- Synta Pharmaceuticals Corp.
Neoplasms Malignant
Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK)
This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.
- Trial name
- NCT01121588
- Testing
- Crizotinib
- Where
- 21 sites in United States, China and 5 more
- Volunteers
- 44 people
- Sponsor
- Pfizer
ALK-positive NSCLC
Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer
This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients
- Trial name
- NCT02393625
- Testing
- Ceritinib (LDK378), Nivolumab
- Where
- 12 sites in United States, Australia and 6 more
- Volunteers
- 57 people
- Sponsor
- Novartis Pharmaceuticals
Non-small Cell Lung Cancer
eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of X-396 (ensartinib) vs. crizotinib in patients with ALK-positive non-small cell lung cancer that have received up to 1 prior chemotherapy regimen and no…
- Trial name
- NCT02767804
- Testing
- X-396 (ensartinib), crizotinib
- Where
- 72 sites in United States, Argentina and 18 more
- Volunteers
- 290 people
- Sponsor
- Xcovery Holdings, Inc.
Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive
This expanded access study has being designed following a demand from the FDA, given the increase in the number of request for single patient INDs for lorlatinib
- Trial name
- NCT03178071
- Testing
- Lorlatinib
- Where
- 49 sites in United States
- 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
Lung Neoplasms
A Study of SHR-1210 in Combination With BP102 in Subjects With Non-squamous NSCLC
SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. This is a Phase II, multicenter, open-label study designed to evaluate the safety and efficacy of SHR-1210 with BP102 in subjects who are chemotherapy naive and have…
- Trial name
- NCT03666728
- Testing
- SHR-1210, BP102
- Where
- China
- Volunteers
- 5 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Non-small Cell Lung Cancer
Study Comparing WX-0593 to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
The primary purpose of this study is to evaluate the efficacy and safety of WX-0593 vs. crizotinib in patients with ALK-positive non-small cell lung cancer who had not received prior systemic therapy
- Trial name
- NCT04632758
- Testing
- WX-0593 Tablets, crizotinib
- Where
- China
- Volunteers
- 292 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.