Clinical trials: ALK-positive Advanced NSCLC
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
Non-Small-Cell Lung, ALK-positive Advanced NSCLC
A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment
The main purpose of the study is to learn how the lung cancer medicines work. The study also looks into treatment sequence of these medicines.
- Conditions
- Non-Small-Cell Lung, ALK-positive Advanced NSCLC, ALK-positive Non-small-cell Lung Cancer, ALK-positive NSCLC
- Trial name
- NCT07567352
- Testing
- lorlatinib
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Pfizer
Non-small Cell Lung Cancer
Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer
To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.
- Trial name
- NSCLC (NCT03607188)
- Testing
- Alkotinib
- Where
- China
- Volunteers
- 17 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Non Small Cell Lung Cancer Metastatic
Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer
Crizotinib is a first-generation ALK tyrosine kinase inhibitor (ITK-ALK). It is the standard first-line treatment for patients with advanced NSCLC with ALK gene rearrangement.
- Trial name
- ORAKLE (NCT04111705)
- Testing
- Lorlatinib
- Where
- 32 sites in France
- Volunteers
- 23 people
- Sponsor
- Intergroupe Francophone de Cancerologie Thoracique
Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative
Efficacy and Safety of Ivonescimab Monotherapy as First-Line Treatment for PD-L1-Positive, Driver Gene-Negative, Locally Advanced or Metastatic NSCLC: A Multicenter, Prospective, Real-World Cohort Study
The treatment decisions, assessment schedule, and study procedures in this research will adhere to the routine clinical practice of each participating center.
- Conditions
- Patients Must Have Histologically or Cytologically Confirmed Locally Advanced or Metastatic NSCLC, EGFR Mutation-negative and ALK Rearrangement-negative, Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score of 0 to 2, No Prior Systemic Therapy Received for the Advanced or Metastatic Disease
- Trial name
- PROMISE (NCT07696832)
- Testing
- Ivonescimab Injection
- Where
- China
- Volunteers
- 265 people
- Sponsor
- Guangdong Association of Clinical Trials
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+ 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
NSCLC Stage IV
Alectinib-induced Endocrine Toxicity
The experimental Cohort A (male ALK+ ANSCLC patients receiving alectinib), the control Cohort B (female ALK+ ANSCLC patients receiving alectinib) and control Cohort C (male NON-ALK ANSCLC patients) were prospectively evaluated…
- Trial name
- TOSS-ALK (NCT06339554)
- Testing
- Alectinib 150 MG [Alecensa]
- Where
- Italy
- Volunteers
- 98 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lung Neoplasms
Camrelizumab Combined With Apatinib Mesylate and Standard Chemotherapy (Pemetrixed + Carboplatin) in Patients With Tyrosine Kinase Inhibitor Failure in ALK-positive Advanced NSCLC
This study is a phase II single-arm clinical study.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with apatinib mesylate and standard chemotherapy (pemetrexed plus carboplatin) in…
- Trial name
- NCT04425135
- Testing
- Camrelizumab, Apatinib, Pemetrixed
- Volunteers
- 59 people
- Sponsor
- The First Affiliated Hospital of Xiamen University
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 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
ALK Gene Rearrangement Positive, Non-Squamous Non-Small Cell Neoplasm of Lung
Alectinib in Combination With Bevacizumab in ALK Positive NSCLC
This single-arm, open-label, phase II clinical study aims to evaluate the progression-Free Survival (PFS) of the combination of Alectinib plus Bevacizumab in untreated and first and second-line chemotherapy failed subjects with…
- Trial name
- NCT03779191
- Testing
- Alectinib, Bevacizumab
- Where
- Mexico
- Volunteers
- 41 people
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
ALK Positive, NSCLC Stage IIIB
Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
The experimental design is exploratory, single-arm, multi-center, real-world research. Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients…
- Conditions
- ALK Positive, NSCLC Stage IIIB, NSCLC Stage IV
- Trial name
- EFLRWR (NCT05132218)
- Testing
- Ensatinib
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Peking University Cancer Hospital & Institute
Non-small Cell Lung Cancer, ALK Gene Rearrangement Positive
Analysis of Biological Characteristics of Advanced ALK-rearranged NSCLC
BioEXALK is a prospective study evaluating the biological characteristics of advanced ALK-rearranged NSCLC treated with next generation TKIs in first line, included in the national EXPLORE ALK cohort (GFPC 03-2019), a…
- Trial name
- BIOEXALK (NCT05122806)
- Testing
- RNAseq
- Where
- 46 sites in France
- Volunteers
- 100 people
- Sponsor
- Groupe Francais De Pneumo-Cancerologie
Non-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation
Alectinib Pharmacokinetic in Patients With NSCLC
This interventional study aims to determine the pharmacokinetics of orally administered alectinib with dose escalation from 300 mg to 600 mg twice daily in Mexican patients with advanced ALK-positive NSCLC.
- Trial name
- NCT05713006
- Testing
- Alectinib Oral Product
- Where
- Mexico
- Volunteers
- 45 people
- Sponsor
- Instituto Nacional de Cancerologia de Mexico
Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent
A Study Of Oral PF-02341066, A C-Met/Hepatocyte Growth Factor Tyrosine Kinase Inhibitor, In Patients With Advanced Cancer
PF-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. PF-02341066 is a new class of drugs called c-Met/Hepatocyte growth factor receptor tyrosine kinase inhibitors.
- Conditions
- Non-Small Cell Lung Cancer ALK-positive, Non-Small Cell Lung Cancer c-Met Dependent, Non-Small Cell Lung Cancer ROS Marker Positive, Systemic Anaplastic Large-Cell Lymphoma
- Trial name
- PROFILE 1001 (NCT00585195)
- Testing
- PF-02341066, Rifampin, Itraconazole
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 596 people
- Sponsor
- Pfizer
Untreated Advanced NSCLC Patients, FISH Identified ALK Fusion Positive or Negative
The Study of Exosome EML4-ALK Fusion in NSCLC Clinical Diagnosis and Dynamic Monitoring
The application of ALK inhibitors in the first-line cancer treatment can significantly increase the PFS and ORR of patients those with EML4-ALK fusion.
- Trial name
- NCT04499794
- Testing
- ALK inhibitor
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Chinese Academy of Medical Sciences
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
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