Lorlatinib
Information
- Drug Name
- Lorlatinib
- Description
- Entry(CIViC)
- 9
CIViC
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| Preclinical study of PF-06463922 in NSCLC in-vitro... | ROS1 | ROS1 CD74-ROS1 G2032R | Sensitivity | true | CIViC Evidence | detail |
| Preclinical study of PF-06463922 in NSCLC in-vitro... | ROS1 | ROS1 CD74-ROS1 L2026M | Sensitivity | true | CIViC Evidence | detail |
| Efficacy of the second generation ALK inhibitor PF... | ALK |
ALK p.Phe1174Leu (p.F1174L) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Phe1174Leu (p.F1174L) ( ENST00000618119.4, ENST00000642122.1, ENST00000389048.8 ) |
Sensitivity | true | CIViC Evidence | detail |
| Patient derived xenografts of neuroblastoma Felix ... | ALK |
ALK p.Phe1245Cys (p.F1245C) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Phe1245Cys (p.F1245C) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| In NB-1643 and LAN-5 neuroblastoma cell lines cont... | ALK |
ALK p.Arg1275Gln (p.R1275Q) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) ALK p.Arg1275Gln (p.R1275Q) ( ENST00000389048.8, ENST00000618119.4, ENST00000642122.1 ) |
Sensitivity | true | CIViC Evidence | detail |
| EML4-ALK variant 1 containing H-3122 NSCLC cells w... | ALK | ALK EML4-ALK | Sensitivity | true | CIViC Evidence | detail |
| In a phase 2 trial, patients with NSCLC with ALK f... | ALK | ALK ALK FUSIONS ALK ALK FUSIONS | Sensitivity | true | CIViC Evidence | detail |
| Case report of a patient with metastatic ALK-rearr... | ALK | ALK EML4-ALK C1156Y | Sensitivity | true | CIViC Evidence | detail |
| Case report of a patient with metastatic ALK-rearr... | ALK | ALK EML4-ALK C1156Y–L1198F | Resitance or Non-Reponse | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT04127110 | Active, not recruiting | Phase 2 | Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients | November 17, 2020 | November 2024 |
| NCT04111705 | Active, not recruiting | Phase 2 | Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer | August 5, 2020 | January 2025 |
| NCT03909971 | Active, not recruiting | Phase 2 | A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China | April 28, 2019 | December 31, 2024 |
| NCT03107988 | Active, not recruiting | Phase 1 | NANT 2015-02: A Phase 1 Study of Lorlatinib (PF-06463922) | September 5, 2017 | December 2025 |
| NCT03126916 | Active, not recruiting | Phase 3 | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) | May 14, 2018 | September 30, 2026 |
| NCT03737994 | Active, not recruiting | Phase 2 | Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer | July 25, 2019 | September 21, 2024 |
| NCT05297890 | Active, not recruiting | Phase 2 | A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer | May 27, 2022 | November 2025 |
| NCT05097599 | Active, not recruiting | Phase 2 | Strata PATH™ (Precision Indications for Approved Therapies) | November 19, 2021 | November 19, 2029 |
| NCT04800822 | Active, not recruiting | Phase 1 | PF-07284892 in Participants With Advanced Solid Tumors | March 17, 2021 | November 29, 2025 |
| NCT06410040 | Active, not recruiting | A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis | August 20, 2023 | June 30, 2024 | |
| NCT03052608 | Active, not recruiting | Phase 3 | A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC | April 27, 2017 | December 31, 2028 |
| NCT04362072 | Active, not recruiting | Phase 4 | Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer | September 29, 2020 | June 25, 2024 |
| NCT03127618 | Approved for marketing | Lorlatinib - PF-06463922 | |||
| NCT04541706 | Completed | Phase 4 | Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India | August 27, 2020 | July 20, 2022 |
| NCT03542305 | Completed | Phase 1 | Lorlatinib Renal Impairment Study | August 23, 2018 | February 20, 2020 |
| NCT03546894 | Completed | 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 | July 23, 2018 | February 13, 2023 | |
| NCT04647110 | Completed | Real-world Therapy of ALK-positive NSCLC in Sweden: the Sequencing of ALK Tyrosine Kinase Inhibitor Drugs and Their Therapeutic Outcomes Based on Data From National Registers. | December 14, 2020 | March 15, 2021 | |
| NCT05167500 | Completed | Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment | December 9, 2021 | December 30, 2022 | |
| NCT06282991 | Completed | A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled | July 22, 2020 | January 18, 2021 | |
| NCT03178071 | No longer available | Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive | |||
| NCT06282874 | Not yet recruiting | Phase 4 | Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases | March 1, 2024 | March 1, 2027 |
| NCT06333899 | Not yet recruiting | Early Phase 1 | Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion | September 1, 2024 | September 1, 2034 |
| NCT02925234 | Recruiting | Phase 2 | The Drug Rediscovery Protocol (DRUP Trial) | August 2016 | December 2027 |
| NCT05144997 | Recruiting | Phase 4 | Lorlatinib Continuation Study | December 28, 2021 | December 28, 2026 |
| NCT04621188 | Recruiting | Phase 2 | Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) | March 19, 2021 | January 2026 |
| NCT05224609 | Recruiting | Phase 1 | A Study to Learn About the Study Medicine (Called Lorlatinib) in People With Liver Dysfunction | April 28, 2022 | August 31, 2024 |
| NCT06378892 | Recruiting | Phase 2 | A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib | March 15, 2024 | May 2028 |
| NCT06361589 | Recruiting | Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients | May 1, 2024 | November 1, 2028 | |
| NCT03505554 | Recruiting | Phase 2 | A Study of Oral Lorlatinib in Patients With Relapsed ALK Positive Lymphoma | October 10, 2017 | December 2024 |
| NCT05740943 | Recruiting | Phase 2 | Induction Lorlatinib in Stage III Non-small Cell Lung Cancer | March 15, 2023 | December 31, 2026 |
| NCT05834348 | Recruiting | A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | June 26, 2023 | February 3, 2025 | |
| NCT06007937 | Recruiting | Phase 1/Phase 2 | A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer | August 17, 2023 | August 17, 2028 |
| NCT04753658 | Terminated | Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib | March 19, 2021 | September 30, 2022 | |
| NCT03726333 | Terminated | Phase 1 | Hepatic Impairment Study for Lorlatinib in Cancer Patients | January 14, 2020 | July 14, 2021 |
| NCT03878524 | Terminated | Phase 1 | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | April 1, 2020 | December 10, 2020 |
| NCT04292119 | Unknown status | Phase 1/Phase 2 | Lorlatinib Combinations in Lung Cancer | May 1, 2020 | March 1, 2023 |
| NCT03439215 | Unknown status | Phase 2 | PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer | June 13, 2017 | June 2022 |
| NCT02927340 | Unknown status | Phase 2 | A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions | October 2016 | May 2023 |
| NCT03612154 | Unknown status | Phase 2 | Study of Lorlatinib in ROS1 Rearranged NSCLC | May 2, 2019 | December 31, 2023 |
| NCT05948462 | Withdrawn | Phase 2 | Lorlatinib in Combination With Chemotherapy in Participants With Metastatic Anaplastic Lymphoma Kinase Positive (ALK+) Non-small Cell Lung Cancer (NSCLC) Who Progressed on Single-agent Lorlatinib | November 2023 | September 2025 |
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- PF-06463922
- Synonym (Drug list of Screening Committee of Anticancer Drugs)
- PF-06463922
- Target (Drug list of Screening Committee of Anticancer Drugs)
- ROS1
- Target (Drug list of Screening Committee of Anticancer Drugs)
- Alk