Floatz Rating
BB66/100
Confidence
Indicative
Sponsor
Chugai Pharmaceutical
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
67High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07617337CT.gov AQUA07 in Patients With ALK-Positive Non-Small Cell Lung Cancer | — | Not Yet Recruiting | — | — | — |
NCT07556549CT.gov A Study to Learn About Study Medicine Lorlatinib, as a First-line Treatment in Chinese Adults With ALK-positive a/mNSCLC | — | Active Not Recruiting | — | — | — |
NCT07567352CT.gov A Study to Learn About Patients With Non-Small Cell Lung Cancer (NSCLC) Who Took Lorlatinib as Their First Treatment | — | Active Not Recruiting | — | — | — |
NCT07415005CT.gov Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer | — | Recruiting | — | — | — |
NCT07083687CT.gov Lorlatinib in ROS1+ NSCLC With Brain Metastasis | — | Not Yet Recruiting | — | — | — |
NCT06678555CT.gov A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer (NSCLC) Which Has Spread Out. | — | Active Not Recruiting | — | — | — |
NCT06893354CT.gov Explore the Mechanisms Underlying Disease Resistance and Potential Primary Resistance Mechanism of Induction Therapy Lorlatinib in Resectable Non-small Cell Lung Cancer (NSCLC) Harboring ALK Positive Mutation Revealed by Single-cell RNA Sequencing and Spatial Transcriptomics | — | Not Yet Recruiting | — | — | — |
NCT06858410CT.gov Lorlatinib Compared with Concurrent/ Sequential Chemoradiotherapy in Stage III ALK Positive Lung Adenocarcinoma | — | Not Yet Recruiting | — | — | — |
NCT06487078CT.gov Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context | — | Recruiting | — | — | — |
NCT06682884CT.gov Lorlatinib as Neoadjuvant Treatment in Stage IB-IIIB ALK-rearranged Non-Small Cell Lung Cancer | — | Not Yet Recruiting | — | — | — |
Show 34 more trialsShow fewer
NCT06690541CT.gov Real-world Study of Local Therapy Changes During 1L Lorlatinib in Unresectable ALK+ NSCLC | — | Not Yet Recruiting | — | — | — |
NCT06876675CT.gov LORLATINIB-related HYPERLIPIDEMIA in ALK+ Non-Small Cell Lung Cancer | — | Enrolling By Invitation | — | — | — |
NCT06532149CT.gov ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer | — | Recruiting | — | — | — |
NCT06282874CT.gov Lorlatinib in Patients With ALK-Positive NSCLC With Brain or Leptomeningeal Metastases | — | Active Not Recruiting | — | — | — |
NCT06361589CT.gov Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients | — | Recruiting | — | — | — |
NCT06378892CT.gov 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 | — | Recruiting | — | — | — |
NCT05948462CT.gov 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 | — | Withdrawn | — | — | — |
NCT06410040CT.gov A Retrospective Study of the Efficacy and Safety of Lolatinib in ALK+ NSCLC Patients With Brain or Meningeal Metastasis | — | Unknown | — | — | — |
NCT06092086CT.gov Lorlatinib as the First-line Treatment in China Advanced ALK+ NSCLC | — | Recruiting | — | — | — |
NCT06007937CT.gov A Study of Lorlatinib in Combination With Ramucirumab in People With Lung Cancer | — | Recruiting | — | — | — |
NCT05834348CT.gov A Study to Learn About the Effectiveness of Cancer Medicines in Patients With Metastatic Non-small Cell Lung Cancer in Norway. | — | Completed | — | — | — |
NCT05740943CT.gov Induction Lorlatinib in Stage III Non-small Cell Lung Cancer | — | Active Not Recruiting | — | — | — |
NCT05297890CT.gov A Study of Lorlatinib in Subjects With ROS1-Positive Non-Small Cell Lung Cancer | — | Active Not Recruiting | — | — | — |
NCT05144997CT.gov Lorlatinib Continuation Study | — | Active Not Recruiting | — | — | — |
NCT05167500CT.gov Efficacy & Safety Study of Lorlatinib in ALK/ROS1 Metastatic NSCLC Patients With Compassionate Use Treatment | — | Completed | — | — | — |
NCT04621188CT.gov Lorlatinib After Failure of First-line TKI in Patients With Advanced ROS1-positive NSCLC (ALBATROS) | — | Active Not Recruiting | — | — | — |
NCT04647110CT.gov 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. | — | Completed | — | — | — |
NCT04127110CT.gov Activity of Lorlatinib Based on ALK Resistance Mutations Detected on Blood in ALK Positive NSCLC Patients | — | Active Not Recruiting | — | — | — |
NCT04541407CT.gov Temodar Plus Tyrosine Kinase Inhibitors for Progressive CNS Disease | — | Completed | — | — | — |
NCT04362072CT.gov Study of Lorlatinib In People With ALK-positive Non-small Cell Lung Cancer | — | Completed | — | — | — |
NCT04541706CT.gov Lorlatinib in ALK Inhibitor Treated Unresectable Advanced/Recurrent ALK-Positive Non Small Cell Lung Cancer Patients in India | — | Completed | — | — | — |
NCT04111705CT.gov Lorlatinib After Failure of First-line Second-generation ALK Kinase Inhibitor in Patients With Advanced ALK-positive Non-small Cell Lung Cancer | — | Completed | — | — | — |
NCT06282991CT.gov A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled | — | Completed | — | — | — |
NCT04292119CT.gov Lorlatinib Combinations in Lung Cancer | — | Unknown | — | — | — |
NCT03737994CT.gov Targeted Treatment for ALK Positive Patients Who Have Previously Been Treated for Non-squamous Non-small Cell Lung Cancer | — | Terminated | — | — | — |
NCT03612154CT.gov Study of Lorlatinib in ROS1 Rearranged NSCLC | — | Unknown | — | — | — |
NCT03909971CT.gov A Study of Lorlatinib in ALK Inhibitor-Treated ALK-Positive NSCLC in China | — | Completed | — | — | — |
NCT03546894CT.gov 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 | — | Completed | — | — | — |
NCT03439215CT.gov PF-06463922 for Crizotinib Pretreated ROS1 Positive Non-small-cell Lung Cancer | — | Unknown | — | — | — |
NCT03052608CT.gov A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC | — | Active Not Recruiting | — | — | — |
NCT02927340CT.gov A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions | — | Unknown | — | — | — |
NCT02584634CT.gov Study to Evaluate Safety, Efficacy, Pharmacokinetics And Pharmacodynamics Of Avelumab In Combination With Either Crizotinib Or PF-06463922 In Patients With NSCLC. (Javelin Lung 101) | — | Terminated | — | — | — |
NCT01970865CT.gov A Study Of PF-06463922 An ALK/ROS1 Inhibitor In Patients With Advanced Non Small Cell Lung Cancer With Specific Molecular Alterations | — | Completed | — | — | — |
NCT03178071CT.gov Expanded Access For Lorlatinib For Patients With Non Small Cell Lung Cancer ALK Positive or ROS1 Positive | — | No Longer Available | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Non-Small Cell Lung Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Lorlatinib (this asset) | Chugai Pharmaceutical | Approved | BB · 66 |
| Necitumumab | Jonsson Comprehensive Cancer Center | P3 | BBB |
| Glumetinib | Shanghai JMT-Bio Inc. | P3 | BBB |
| Veliparib | AbbVie | P3 | BBB |
| d-0316 | Betta Pharmaceuticals Co., Ltd. | P2/3 | BBB |
| Icotinib | The First Affiliated Hospital of Guangzhou Medical University | P4 | BBB |
| Zoledronate | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | P4 | BBB |
| Onartuzumab | Hoffmann-La Roche | P3 | BBB |
| Avitinib | Hangzhou ACEA Pharmaceutical Research Co., Ltd. | P3 | BBB |
+42 more in the Non-Small Cell Lung Carcinoma cohort
Other indications for Lorlatinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Hepatocellular Carcinoma | — | P4 | BB · 64 |
| Neoplastic Meningitis | — | P4 | B · 62 |
| Metastatic Malignant Neoplasm In The Brain | — | P4 | B · 59 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Lorlatinib in Non-Small Cell Lung Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/lorlatinib-non-small-cell-lung-carcinoma
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