Clinical trials: ALK-positive NSCLC
Non-small Cell Lung Cancer
Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC).
- Trial name
- NCT03087448
- Testing
- Ceritinib, Trametinib
- Where
- 2 sites in United States
- Volunteers
- 9 people
- Sponsor
- University of California, San Francisco
ALK Positive, Locally Advanced Malignant Solid Neoplasm
Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer
This phase I trial studies the side effects and best dose of ceritinib and everolimus in treating patients with solid tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or to other…
- Conditions
- ALK Positive, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, ROS1 Gene Rearrangement
- Trial name
- NCT02321501
- Testing
- Ceritinib, Everolimus, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
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 Metastatic, ALK Gene Rearrangement Positive
Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib
The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the…
- Conditions
- Non-small Cell Lung Cancer Metastatic, ALK Gene Rearrangement Positive, ROS-1 Gene Rearrangement Positive
- Trial name
- LORLATU (NCT03727477)
- Where
- 30 sites in France
- Volunteers
- 291 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Potentially Resectable ALK Positive Non-Small Cell Lung Cancer
Neoadjuvant Therapy With Iruplinalkib for Potentially Resectable ALK Positive NSCLC: A Single Arm, Exploratory Trial
Fusion of anaplastic lymphoma kinase (ALK) is an important driving gene for NSCLC, with an incidence rate of 3-7%. In patients with advanced ALK mutation NSCLC, first-line use of ALK inhibitors significantly improves progression…
- Trial name
- NCT06282536
- Testing
- Iruplinalkib, surgery
- Volunteers
- 20 people
- Sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
ALK-positive Non-small Cell Lung Cancer
A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges
This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed…
- Trial name
- Ascend-7 (NCT02336451)
- Testing
- Ceritinib
- Where
- 57 sites in United States, Australia and 15 more
- Volunteers
- 156 people
- Sponsor
- Novartis Pharmaceuticals
ALK+ Non-Small-Cell Lung Carcinoma
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context
Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World context
- Trial name
- LOREA (NCT06487078)
- Testing
- Lorlatinib
- Where
- 32 sites in France
- Volunteers
- 90 people
- Sponsor
- Pfizer
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.
Advanced Non-Small Cell Lung Cancer
Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India
Lorlatinib is a third-generation, oral, reversible, ATP-competitive, macrocyclic TKI of ALK and ROS1. Lorlatinib was specifically designed to penetrate the CNS and to overcome known secondary resistance mutations in the ALK…
- Trial name
- NCT04541706
- Testing
- Lorlatinib
- Where
- 12 sites in India
- Volunteers
- 100 people
- Sponsor
- Pfizer
ALK-positive NSCLC, ALK-Positive Lung Cancer
A Phase 1/2 Study of TRI-611 in ALK-Positive NSCLC
The goal of this clinical trial is to learn about the safety and recommended dose of TRI-611 when administered to adults with ALK-positive non-small cell lung cancer (NSCLC).
- Conditions
- ALK-positive NSCLC, ALK-Positive Lung Cancer, ALK-positive Non-small Cell Lung Cancer
- Trial name
- NCT07491497
- Testing
- TRI-611
- Where
- 16 sites in United States, Australia
- Volunteers
- 160 people
- Sponsor
- TRIANA Biomedicines, Inc.
Carcinoma, Non-Small-Cell Lung, Brain Metastases
Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases
This study is an investigator-initiated, prospective, open-label, single-arm, multicenter clinical trial aimed at exploring the antitumor activity of Lorlatinib in ALK-positive NSCLC patients with brain/ leptomeningeal metastases.
- Conditions
- Carcinoma, Non-Small-Cell Lung, Brain Metastases, Leptomeningeal Metastasis
- Trial name
- NCT06282874
- Testing
- Lorlatinib
- Where
- 3 sites in China
- Volunteers
- 41 people
- Sponsor
- Guangdong Association of Clinical Trials
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.
Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma
Ensartinib, Carboplatin, Pemetrexed and Bevacizumab for the Treatment of Stage IIIC or IV or Recurrent ALK-Positive Non-small Cell Lung Cancer
This phase Ib trial finds the best dose and side effects of ensartinib and its effects when given with carboplatin, pemetrexed and bevacizumab for in treating patients with ALK-positive non-small cell lung cancer that is stage…
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8
- Trial name
- NCT04837716
- Testing
- Bevacizumab, Carboplatin, Ensartinib
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- M.D. Anderson Cancer Center
Carcinoma, Non-Small-Cell Lung, Anaplastic Lymphoma Kinase
A Study of Brigatinib to Treat Adults With Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non Small Cell Lung Cancer (NSCLC)
The aims of the study are to assess the safety profile of brigatinib and the clinical response rates in adults with Anaplastic Lymphoma Kinase (ALK)-Positive Metastatic Non Small Cell Lung Cancer (NSCLC).
- Trial name
- NCT04887519
- Testing
- No Intervention
- Where
- Argentina
- Volunteers
- 39 people
- Sponsor
- Takeda
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
Brigatinib Plus Chemotherapy or Local Consolidation Therapy in ALK Positive Advanced Non-small Cell Lung Cancer (BrightStar-2)
The goal of this clinical research study is to learn if the combination of brigatinib and either local consolidation therapy (such as radiotherapy or surgery) or chemotherapy (pemetrexed and carboplatin) can help to control the…
- Trial name
- NCT06522360
- Testing
- Brigatinib, Carboplatin, Pemetrexed
- Sponsor
- M.D. Anderson Cancer Center
ALK+ Advanced NSCLC
A Study of Brigatinib Compared to Alectinib in Adults With Non-Small-Cell Lung Cancer
Brigatinib is a medicine that binds to the surface of tumor cells in some cancers and delivers a dose of chemotherapy directly to the tumor.
- Trial name
- ALTA-3 (NCT03596866)
- Testing
- Brigatinib, Alectinib
- Where
- 114 sites in United States, Argentina and 18 more
- Volunteers
- 248 people
- Sponsor
- Takeda
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
Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer
This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell…
- Trial name
- NCT05341583
- Testing
- Ensartinib
- Where
- China
- Volunteers
- 202 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
ALK-positive Non-small Cell Lung Cancer
Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung cancer and slow down cancer growth and prevent it from spreading.
- Trial name
- NCT02513667
- Testing
- Ceritinib, Stereotactic ablative body radiation
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of Texas Southwestern Medical Center