Clinical trials: Anaplastic Lymphoma Kinase-positive
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
Non Small Cell Lung Cancer
TGRX-326 Chinese Phase III for Advanced Non-small Cell Lung Cancer (NSCLC)
This is a multi-center, randomized, open-label, Phase III clinical trial which compares the safety and efficacy of TGRX-326 with crizotinib in patients with ALK-positive advanced or metastatic NSCLC
- Trial name
- NCT06082635
- Testing
- TGRX-326, Crizotinib
- Where
- China
- Volunteers
- 321 people
- Sponsor
- Shenzhen TargetRx Co., Ltd.
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
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.
ALK-positive NSCLC
Study of TQ-B3139 in Subjects With Anaplastic Lymphoma Kinase (ALK) Positive Non-Small Cell Lung Cancer (NSCLC) Previously Treated With Crizotinib
To evaluate the efficacy and safety of TQ-B3139 in subjects with ALK-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic…
- Trial name
- NCT04056572
- Testing
- TQ-B3139
- Where
- 2 sites in China
- Volunteers
- 135 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Non-Small Cell Lung Cancer, ALK-positive
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLC
This randomized, multicenter, Phase III, open-label study will evaluate the efficacy and safety of SAF-189s versus crizotinib treatment in participants with treatment-naive ALK-positive advanced NSCLC.
- Conditions
- Non-Small Cell Lung Cancer, ALK-positive, SAF-189s
- Trial name
- NCT06569420
- Testing
- Drug: Foritinib Succinate, Drug: Crizotinib
- Where
- China
- Volunteers
- 275 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
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.
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
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.
Non-small Cell Lung Cancer
A Study Evaluates the Safety and Efficacy of WX-0593 in ALK -Positive, or ROS1-positive Non-small Cell Lung Cancer
The purpose of the study is to evaluate safety and efficacy of WX-0593 oral tablets in ALK -positive, or ROS1-positive non-small cell lung cancer (NSCLC)
- Trial name
- NCT04641754
- Testing
- WX-0593 Tablets
- Where
- 41 sites in China
- Volunteers
- 176 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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
Non-Small Cell Lung Cancer
Phase I Study of a Selective ALK Inhibitor PLB1003 in Patients With ALK+ NSCLC.
This phase I, first-in-human dose-escalation study was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose (RP2D), dose-limiting toxicities (DLTs), pharmacokinetics (PK) profile, and preliminary…
- Trial name
- NCT03130881
- Testing
- PLB1003
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Pearl Biotechnology Limited Liability Company
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
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.
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
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)
Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets'…
- Trial name
- Drugs-SNPs (NCT05987956)
- Testing
- ALECENSA - alectinib hydrochloride capsule
- Where
- 2 sites in United States
- Volunteers
- 600 people
- Sponsor
- Medicine Invention Design, Inc
Non-small Cell Lung Cancer
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.
This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer.
- Trial name
- NCT02292550
- Testing
- Ribociclib, Ceritinib
- Where
- 8 sites in United States, France and 4 more
- Volunteers
- 27 people
- Sponsor
- Novartis Pharmaceuticals
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