Study Summary
This trial is testing whether a new drug, lorlatinib, is better than the standard drug, crizotinib, at treating patients with a certain type of lung cancer who have not yet received treatment.
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 27 Secondary · Reporting Duration: From time of Study Start up to 45 months
Day 2
Change From Baseline in Total Scores of Beck Depression Inventory (BDI)-II (Mood Assessment) Across Time
Number of Participants With Suicidal Ideation and Suicidal Behavior Across Time
Day 1
Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Index Across Time
Change From Baseline in Health Status as Assessed by EuroQol 5 Dimension 5 Level (EQ-5D-5L) - Visual Analogue Scale (VAS) Across Time
Month 33
Number of Participant With Maximum Increase From Baseline in Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
Number of Participant With Vital Signs and Body Weight Data Meeting Pre-defined Criteria
Number of Participants With Changes in Chemistry Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
Number of Participants With Changes in Hematology Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
Number of Participants With Changes in Lipid Laboratory Parameters From Baseline Maximum NCI-CTCAE Grade Lower Than 3 to Postbaseline Maximum Grade 3 or Grade 4
Number of Participants With Maximum Decrease From Baseline Greater Than or Equal to 20 Points in Left Ventricular Ejection Fraction (LVEF) Percentage
Time to Deterioration (TTD) in Participant Reported Pain in Chest, Dyspnea, or Cough From QLQ-LC13
Day 38
Therapeutic procedure
Change From Baseline in Lung Cancer Symptoms as Assessed by the EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ- LC13) During Overall Treatment
Month 33
Duration of Response (DR) Based on BICR Assessment
Intracranial Duration of Response (IC-DR) Based on BICR Assessment
Intracranial Objective Response Rate (IC-ORR) - Percentage of Participants With Intracranial Objective Response (IC-OR) Based on BICR Assessment
Intracranial Time to Progression (IC-TTP) Based on BICR Assessment
Intracranial Time to Tumor Response (IC-TTR) Based on BICR Assessment
Number of Participants With Treatment-Emergent Adverse Events (AEs; All-Causality and Treatment-Related)
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on BICR Assessment
Objective Response Rate (ORR) - Percentage of Participants With Objective Response (OR) Based on Investigator's Assessment
Overall Survival (OS)
Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) Assessment
Progression-Free Survival (PFS) Based on Investigator's Assessment
Time to Tumor Response (TTR) Based on BICR Assessment
Month 45
PFS2 Based on Investigator's Assessment
Day 7
Number of Participant With ALK Domain Mutation in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
Number of Participant With ALK Fusion Variant in Plasma Circulating Nucleic Acid (CNA) Analysis at Screening, Cycle 2 Day 1 and Cycle 7 Day 1
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Mild Impairment
13%Blood pressure increased
13%Vessel puncture site pain
13%Myalgia
Trial Design
2 Treatment Groups
Crizotinib
1 of 2
Lorlatinib
1 of 2
Active Control
Experimental Treatment
296 Total Participants · 2 Treatment Groups
Primary Treatment: Lorlatinib · No Placebo Group · Phase 3
Lorlatinib
Drug
Experimental Group · 1 Intervention: Lorlatinib · Intervention Types: DrugCrizotinib
Drug
ActiveComparator Group · 1 Intervention: Crizotinib · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from time of study start up to 45 months
Who is running the clinical trial?
PfizerLead Sponsor
4,353 Previous Clinical Trials
7,174,783 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,308 Previous Clinical Trials
4,836,641 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Shaw, Alice T., Todd M. Bauer, Filippo de Marinis, Enriqueta Felip, Yasushi Goto, Geoffrey Liu, Julien Mazieres, et al.. 2020. “First-line Lorlatinib or Crizotinib in Advanced alk-positive Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2027187.
- Shaw, Alice T, Enriqueta Felip, Todd M Bauer, Benjamin Besse, Alejandro Navarro, Sophie Postel-Vinay, Justin F Gainor, et al.. 2017. “Lorlatinib in Non-small-cell Lung Cancer with ALK or ROS1 Rearrangement: An International, Multicentre, Open-label, Single-arm First-in-man Phase 1 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(17)30680-0.
- Gainor, Justin F, and Alice T Shaw. 2017. “J-ALEX: Alectinib Versus Crizotinib in ALK -positive Lung Cancer”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(17)31074-7.
- Solomon, Benjamin J, Todd M Bauer, Filippo de Marinis, Enriqueta Felip, Yasushi Goto, Geoffrey Liu, Julien Mazieres, et al.. 2021. “Plain Language Summary of the CROWN Study Comparing Lorlatinib with Crizotinib for People with Untreated Non-small Cell Lung Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-0904.
- Solomon, Benjamin J, Todd M Bauer, Filippo de Marinis, Enriqueta Felip, Yasushi Goto, Geoffrey Liu, Julien Mazieres, et al.. 2021. “Plain Language Summary of the CROWN Study Comparing Lorlatinib with Crizotinib for People with Untreated Non-small Cell Lung Cancer”. Future Oncology. Future Medicine Ltd. doi:10.2217/fon-2021-0904.
- Solomon BJ, Bauer TM, Ignatius Ou SH, Liu G, Hayashi H, Bearz A, Penkov K, Wu YL, Arrieta O, Jassem J, Calella AM, Peltz G, Polli A, Thurm H, Mok T. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients With ALK-Positive Advanced Non-Small-Cell Lung Cancer From the Phase III CROWN Study. J Clin Oncol. 2022 Nov 1;40(31):3593-3602. doi: 10.1200/JCO.21.02278. Epub 2022 May 23.
- Gainor JF, Shaw AT. J-ALEX: alectinib versus crizotinib in ALK-positive lung cancer. Lancet. 2017 Jul 1;390(10089):3-4. doi: 10.1016/S0140-6736(17)31074-7. Epub 2017 May 10. No abstract available.
- 2017. "A Study Of Lorlatinib Versus Crizotinib In First Line Treatment Of Patients With ALK-Positive NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03052608.
Frequently Asked Questions
Is this the first study of its kind?
"Since 2011, when the first clinical study on lorlatinib was conducted, this medication has undergone extensive research. The first 44-person trial was sponsored by Pfizer and, following its success, lorlatinib received Phase 1 drug approval. Now, 47 clinical trials are ongoing in 1221 cities across 37 countries." - Anonymous Online Contributor
Unverified Answer
Does Lorlatinib have any serious side effects?
"This particular medication, Lorlatinib, is in Phase 3 of clinical trials. This means that while there is data supporting its efficacy, there is also multiple rounds of data affirming its safety. Consequently, our team at Power rates Lorlatinib as being a 3 in terms of safety." - Anonymous Online Contributor
Unverified Answer
Could you provide some context regarding Lorlatinib research?
"53 clinical trials studying lorlatinib have been completed since 2011, with 47 more ongoing. A large proportion of these studies are being conducted in Dickson, Florida." - Anonymous Online Contributor
Unverified Answer