What side effects are associated with this type of intervention?

Common treatments for ALK-positive NSCLC, such as Lorlatinib, Crizotinib, and other ALK inhibitors, often lead to side effects including fatigue, dyspnea (shortness of breath), and cough. Additionally, patients may experience gastrointestinal issues like nausea and diarrhea, as well as liver enzyme abnormalities. Serious adverse events can include pneumonitis and hepatotoxicity. These treatments aim to improve quality of life and manage symptoms, but monitoring for these side effects is crucial.

What prior FDA approvals exist?

The FDA has approved several ALK inhibitors for the treatment of Non-Small Cell Lung Cancer (NSCLC). These include alectinib and ceritinib, which have shown clinical benefits in treatment-naïve patients and as second-line therapy after crizotinib. Brigatinib and lorlatinib have also demonstrated activity in further lines of therapy. These drugs have been effective in improving responses, particularly in patients with brain metastases.

What other types of research exist?

Promising alternatives to Lorlatinib for NSCLC patients include entrectinib and ceritinib, which have shown efficacy in patients with ALK and ROS1 rearrangements. Additionally, afatinib has demonstrated activity in NRG1-positive lung cancer. These options provide viable alternatives for patients considering treatment in 2024.

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Lorlatinib for Lung Cancer

Phase 4

Waitlist Available

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have adequate Bone Marrow, Liver, Renal, and Pancreatic Function

Be older than 18 years old

Must not have

Female participants who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to continue providing lorlatinib to patients who are still benefiting from it. Lorlatinib is a medication that helps stop cancer cells from growing. The trial will also collect more safety data to better understand any side effects. Lorlatinib is used to treat non-small-cell lung cancer with ALK or ROS1 rearrangement, and it has been studied to assess its safety and effectiveness.

Who is the study for?

This trial is for individuals with non-small cell lung cancer who are benefiting from ongoing Lorlatinib treatment in previous Pfizer studies. They must have good bone marrow, liver, kidney, and pancreatic function and agree to follow reproductive guidelines. Pregnant or breastfeeding women can't participate.

What is being tested?

The study continues providing Lorlatinib to patients from prior trials who still benefit from it. It aims to gather more safety data on the long-term use of Lorlatinib in treating non-small cell lung cancer.

What are the potential side effects?

While specific side effects aren't listed here, common ones associated with Lorlatinib may include swelling, weight gain, mood effects, nerve damage causing tingling or pain, and high cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My bone marrow, liver, kidneys, and pancreas are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events leading to permanent discontinuation of study intervention

Number of serious adverse events reported for all participants

Side effects data

From 2024 Phase 2 trial • 109 Patients • NCT03909971

87%

Hypertriglyceridaemia

64%

Weight increased

54%

Hypercholesterolaemia

46%

Alanine aminotransferase increased

45%

Aspartate aminotransferase increased

43%

Blood cholesterol increased

28%

Gamma-glutamyltransferase increased

28%

Anaemia

27%

Hyperglycaemia

24%

Hypoalbuminemia

21%

Electrocardiogram QT prolonged

19%

Hyperuricaemia

19%

Oedema peripheral

18%

Low density lipoprotein increased

18%

Arthralgia

16%

Blood triglycerides increased

15%

Hypoaesthesia

13%

Amylase increased

13%

Hypertension

10%

Upper respiratory tract infection

10%

Peripheral swelling

10%

Hypokalemia

Blood creatinine increased

Platelet count decreased

Cough

Rash

Lipase increased

Proteinuria

Sinus tachycardia

High density lipoprotein increased

Hematuria

Pyrexia

Sinus bradycardia

Neutrophil count decreased

Pericardial effusion

Blood glucose increased

Vision blurred

Blood alkaline phosphatase increased

Diarrhea

Pain

Pneumonia

Atrioventricular block first degree

Hyperlipidaemia

Blood creatine phosphokinase increased

Blood pressure increased

Blood uric acid increased

Hyponatremia

Dyspnea

Blood albumin decreased

Haemoglobin decreased

Vomiting

Lymphocyte count decreased

Blood phosphorus decreased

Pneumonitis

Ulna fracture

Hepatic function abnormal

Cholecystitis

Cholelithiasis

Drug-induced liver injury

Embolism

Bronchial haemorrhage

Neoplasm progression

Albumin urine present

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 1

Cohort 2

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LorlatinibExperimental Treatment1 Intervention

Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorlatinib

2018

Completed Phase 4

~640

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted therapies for Non-Small Cell Lung Cancer (NSCLC), such as ALK and ROS1 inhibitors like Lorlatinib, work by blocking specific proteins that drive cancer growth in patients with certain genetic mutations. ALK inhibitors target the anaplastic lymphoma kinase protein, while ROS1 inhibitors focus on the ROS1 protein. These treatments are significant because they offer a personalized approach, leading to better outcomes and fewer side effects compared to traditional chemotherapy, making them particularly beneficial for NSCLC patients with these genetic alterations.