Clinical trials: ALK-positive Advanced NSCLC
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.
Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N
A Real World Study of Ensartinib in Advanced ALK-positive NSCLC
The primary objective of this study is to evaluate the efficacy and safety of Ensartinib in advanced ALK-positive non-small cell lung cancer, and the mechanisms of population pharmacokinetics and resistance to Ensartinib.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase I1171N, Ensartinib
- Trial name
- NCT05498064
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 490 people
- Sponsor
- Peking Union Medical College Hospital
Non-small Cell Lung Cancer, Lung Cancer
An Expanded Access Study of Brigatinib for Patients With ALK-positive Advanced Non-Small Cell Lung Cancer
The purpose of this study is to provide brigatinib for those patients with locally advanced and/or metastatic patients with ALK+ NSCLC on an expanded access basis due to their inability to meet eligibility criteria for on-going…
- Conditions
- Non-small Cell Lung Cancer, Lung Cancer, Advanced Malignancies, Carcinoma
- Trial name
- NCT02784158
- Testing
- Brigatinib
- Where
- 3 sites in United States
- Sponsor
- Ariad Pharmaceuticals
Non-small Cell Lung Cancer
The Patient-Reported Outcomes in ALK Positive Advanced NSCLC in China
This is a multicenter, prospective, longitudinal observational study designed to evaluate the patient-reported outcomes and safety profiles of patients with ALK positive advanced Non-Small Cell Lung Cancer (NSCLC) who received…
- Trial name
- NCT06586801
- Testing
- Patient-reported outcome
- Volunteers
- 800 people
- Sponsor
- Shanghai East Hospital
Solid Tumor
PF-07284892 in Participants With Advanced Solid Tumors
The purpose of this first-in-patient, open label study is to determine the maximum tolerated dose and/or recommended dose for further study of PF-07284892 as a single agent and in combination with lorlatinib, encorafenib and…
- Trial name
- NCT04800822
- Testing
- PF-07284892, lorlatinib, binimetinib
- Where
- 11 sites in United States
- Volunteers
- 53 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
Phase I/II Study of SY-3505 in Patients With ALK-positive Advanced Non-small Cell Lung Cancer
This is a phase I/II, open-label and multi-center study of SY-3505, a third-generation ALK TKI, in patients with advanced ALK-positive non-small cell lung cancer (ALK-positive NSCLC).
- Trial name
- NCT05257512
- Testing
- SY-3505
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
Non Small Cell Lung Cancer, Advanced Cancer
Crizotinib in ALK Rearranged Non-small-cell Lung Cancer
This is a multicenter, observational, retrospective cohort study aimed at assessing the efficacy and safety of crizotinib in ALK positive NSCLC treated in real life setting.
- Conditions
- Non Small Cell Lung Cancer, Advanced Cancer, Metastatic Cancer
- Trial name
- SPECIALK (NCT04317651)
- Where
- 23 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Fondazione Ricerca Traslazionale
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
AUY922 for Advanced ALK-positive NSCLC
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer.
- Trial name
- NCT01752400
- Testing
- AUY922
- Where
- 4 sites in United States
- Volunteers
- 6 people
- Sponsor
- Massachusetts General Hospital
Non-small Cell Lung Cancer (NSCLC)
A Study to Learn About Brigatinib Treatment Information Available in Chinese Participants With Non-Small-cell Lung Cancer (NSCLC)
The main aim of this study is to learn about the time between the start and stop of treatment with brigatinib in Chinese participants with non-small-cell lung cancer (NSCLC) and who have been positively diagnosed with having the…
- Trial name
- Brilliant (NCT05721950)
- Testing
- Brigatinib
- Where
- China
- Volunteers
- 154 people
- Sponsor
- Takeda
Non Small Cell Lung Cancer, ALK Gene Mutation
Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)
This is a phase II randomized, open-labelled, non-comparative multicenter study in which ALK+ NSCLC patients who are naïve of treatment for advanced disease will be randomized to receive brigatinib monotherapy (Arm A) or…
- Trial name
- MP-ALK (NCT05200481)
- Testing
- Brigatinib 180 MG, Carboplatin, Pemetrexed
- Where
- 29 sites in France
- Volunteers
- 110 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Non-Small Cell Lung Cancer
Ensartinib in Combination With Bevacizumab in ALK-positive NSCLC Patients With TP53 Mutation
This is a prospective, single-arm, multicenter, phase II study to investigate the efficacy and safety of Ensartinib plus Bevacizumab in metastatic anaplastic lymphoma kinase (ALK)-rearranged Non-Small Cell Lung Cancer (NSCLC)…
- Trial name
- EAGLE (NCT05491811)
- Testing
- Ensartinib, Bevacizumab
- Where
- China
- Volunteers
- 47 people
- Sponsor
- Sun Yat-sen University
Advanced Non-Small Cell Lung Cancer
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer
This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.
- Trial name
- NCT07415005
- Testing
- Lorlatinib
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- M.D. Anderson Cancer Center
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.
Non-Small Cell Lung Cancer ALK-positive
A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC
The purpose of this retrospective study is to learn about the real-world effects of the study medicine lorlatinib for the first-line treatment of Chinese adult patients who were diagnosed with ALK-positive a/mNSCLC.
- Trial name
- NCT07556549
- Testing
- Lorlatinib
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer Metastatic
Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
This is a phase IV multicenter trial to evaluate the pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.
- Trial name
- NCT02228421
- Where
- 3 sites in Canada
- Volunteers
- 29 people
- Sponsor
- PeriPharm
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 in Neo-adjuvant Treatment of Stage III NSCLC
Stage III NSCLC is a heterogeneous group of tumors with a wide spectrum of clinical presentations. Across this wide spectrum of heterogeneity, there is no single definitive therapeutic approach and the definition of the most…
- Trial name
- ALNEO (NCT05015010)
- Testing
- Alectinib
- Where
- 20 sites in Italy
- Volunteers
- 33 people
- Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
Non-small Cell Lung Cancer Metastatic
Study to Evaluate Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
This is a phase IV multicenter trial to evaluate the mechanisms of resistance and pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell…
- Trial name
- NCT02041468
- Where
- 8 sites in Canada
- Volunteers
- 29 people
- Sponsor
- Jewish General Hospital
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