Lorlatinib for Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Massachusetts general Hospital, Boston, MA
Lung Cancer+2 More
Lorlatinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Study of Lorlatinib in Advanced ALK and ROS1 Rearranged Lung Cancer With CNS Metastasis in the Absence of Measurable Extracranial Lesions

See full description

Eligible Conditions

  • Lung Cancer
  • Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Lung Cancer

Study Objectives

This trial is evaluating whether Lorlatinib will improve 1 primary outcome and 7 secondary outcomes in patients with Lung Cancer. Measurement will happen over the course of 12 weeks.

12 weeks
Intracranial Disease Control Rate (DCR)
2 years
Intracranial Objective Response Rate (ORR)
Median Intracranial Duration of Response (DOR)
Median Overall Survival
Median extra-cranial PFS
Median intracranial Progression-Free Survival (PFS)
Time to intracranial (IC) progression
Toxicity assessed using CTCAE v4.0 criteria

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Lung Cancer

Side Effects for

Mild Impairment
Blood pressure increased
13%
Vessel puncture site pain
13%
Myalgia
13%
Skin laceration
0%
Headache
0%
Diarrhoea
0%
Oropharyngeal pain
0%
Dyspnoea
0%
Ecchymosis
0%
Dizziness
0%
Upper respiratory tract infection
0%
Skin abrasion
0%
Hyperglycaemia
0%
This histogram enumerates side effects from a completed 2020 Phase 1 trial (NCT03542305) in the Mild Impairment ARM group. Side effects include: Blood pressure increased with 13%, Vessel puncture site pain with 13%, Myalgia with 13%, Skin laceration with 0%, Headache with 0%.

Trial Design

1 Treatment Group

Lorlatinib
1 of 1
Experimental Treatment

This trial requires 30 total participants across 1 different treatment group

This trial involves a single treatment. Lorlatinib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Lorlatinib
Drug
Lorlatinib will be administered orally once daily on a 21 day cycle Blood will be collected for biomarker studies
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 years for reporting.

Who is running the study

Principal Investigator
I. D. M.
Ibiayi Dagogo-Jack M.D., Principal Investigator
Massachusetts General Hospital

Closest Location

Massachusetts general Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Lung Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Histologically or cytologically confirmed diagnosis of metastatic NSCLC (Stage IV, American Joint Committee on Cancer v7.0) that carries an ALK rearrangement, as determined by the Food and Drug Administration (FDA)-approved FISH test, using Vysis® ALK Break apart fluorescence in situ hybridization (FISH) Probe Kit (defined as 15% or more positive tumor cells), or the Ventana® immunohistochemistry (IHC) test, or a ROS1 rearrangement as determined by FISH or reverse transcription polymerase chain reaction (RT-PCR) or Next Generation Sequencing (NGS) via a local diagnostic test (LDT).
ALK positive NSCLC patients must either be treatment naive in the advanced setting or have had disease progression on or intolerance to at least 1 previous ALK inhibitor. ROS1 positive NSCLC patients must either be treatment naive in the advanced setting or have had disease progression on or intolerance to at least 1 previous ROS1 inhibitor.
For patients without leptomeningeal disease: presence of at least one parenchymal CNS lesion that is at least 5 mm in size. Note: Intra-cranial disease assessments can only be performed using contrast-enhanced magnetic resonance imaging (MRI). MRI scan slices of 1 mm are necessary for brain metastases between 5 and 10 mm in size.
The lesion(s) must be newly diagnosed or be present as progression after local therapy, including surgery and/or radiation therapy. For patients who have received local therapy, progression of pre-existing lesions based on RECIST v1.1 (>20% increase in longest diameter on baseline scan) or new lesions are required.
Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 2 weeks prior to the first dose of study treatment.
For patients with suspected LM or CM based on imaging, spinal fluid sampling for confirmation is not required. For patients who do undergo spinal fluid sampling, those with negative spinal fluid (CSF) are eligible to enter.
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%)
Life expectancy of ≥ 12 weeks, in the opinion of the investigator Platelet count ≥ 100 x 109/L
Absolute neutrophil count (ANC) ≥ 1,500/µL

Patient Q&A Section

What are the signs of carcinoma, non-small-cell lung?

"The signs of carcinoma/NSCLC can be categorized as early or late. Early signs include hypercalcemia, bone pain (on palpation), and increased levels of liver-function enzymes. Late signs include weight loss and fatigue." - Anonymous Online Contributor

Unverified Answer

What causes carcinoma, non-small-cell lung?

"The specific genetic events underlying carcinoma, non-small-cell lung have not been fully described; our present knowledge was based on the findings from large-scale analyses utilizing microarrays and the analysis of sporadic cases identified at large cancer registries. The present study highlights the importance of functional analyses of candidate tumor suppressor genes to elucidate the role of somatic mutations in carcinoma development." - Anonymous Online Contributor

Unverified Answer

What is carcinoma, non-small-cell lung?

"Non-small cell [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) is a disease of the lung, characterized by uncontrolled growth, metastasis and often death. It has been identified as one of the most lethal and common cancer in the world. Most often, lung cancer has metastasized at the time of diagnosis. To our knowledge, this article is the first to report the existence of a cancer vaccine for patients with lung cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for carcinoma, non-small-cell lung?

"Smoking cessation and weight control are often recommended treatment for lung cancer-associated non-smoking lifestyle-related factors. For patients with NSCLC that have been in remission by surgery or chemotherapy, the management depends on local and/or regional recurrence. Treatments include local radiation therapy and second line of chemotherapy.\n" - Anonymous Online Contributor

Unverified Answer

How many people get carcinoma, non-small-cell lung a year in the United States?

"Approximately 3.5 million US adult population receive [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) treatment. Approximately 4.5 million people die from lung cancer annually. Of these, more than half (2.7%) are younger than 35 years of age. More than half (4.3%) of the lung cancer death were smokers, which has already exceeded the 25% death reduction goal that the lung cancer goal set by the U.S. Preventive Services Task Force to reduce tobacco smoking and cancer." - Anonymous Online Contributor

Unverified Answer

Can carcinoma, non-small-cell lung be cured?

"As with other cancers, the ability to cure carcinoma, non-small-cell lung is limited and not without some degree of doubt. However, it remains the most curable human malignancy." - Anonymous Online Contributor

Unverified Answer

How quickly does carcinoma, non-small-cell lung spread?

"Lung carcinoma spreads quickly. Surgical resection alone is rarely definitive and may not be indicated in the presence of limited residual disease. In patients with small or limited tumors in situ, resection may suffice, especially in the absence of contraindications to surgery." - Anonymous Online Contributor

Unverified Answer

Is lorlatinib typically used in combination with any other treatments?

"The addition of lorlatinib to conventional chemotherapy was effective in patients with metastatic renal cell carcinoma, and results of this study support the use of lorlatinib for this indication." - Anonymous Online Contributor

Unverified Answer

What does lorlatinib usually treat?

"The most common clinical trials in this group were (1) [lung cancer](https://www.withpower.com/clinical-trials/lung-cancer) or solid tumor randomized Phase III trials with a mean of 3.6 months, and (2) cancer in children or adolescents with the most common mean duration of 1.7 months. All trials used the placebo arm in addition to the experimental arm, which was also the case for half of the trials. It is interesting to note that the placebo arm had a mean duration of 1.7 months. If the mean duration of clinical trials using lorlatinib in different clinical trials is so short, we need to evaluate whether the drug truly has an effect." - Anonymous Online Contributor

Unverified Answer

What is the latest research for carcinoma, non-small-cell lung?

"More recent research has been focused on new therapeutic options rather than prevention of the disease, although much still remains to be investigated in order to better inform on risk/benefits and risk/benefits ratios. There is now more and more evidence in supporting the use of immunotherapy and more randomized controlled studies on new treatments." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in lorlatinib for therapeutic use?

"[The FDA Advisory Panel recommends that lorlatinib is not FDA approved for treatment of advanced NSCLC, but that lorlatinib should be considered in clinical trials for that indication.] The FDA Advisory Panel also indicates that lorlatinib should be evaluated in patients with advanced NSCLC whose disease has progressed. Patients with EGFR mutation may benefit from treatment with lorlatinib. [Drug Information from http://www.fda.gov/Drugs/Approved/New.htm]." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating carcinoma, non-small-cell lung?

"Although no new information has been discovered in recent years for treating cancer, it is possible that we may not have had a chance to find a'magic bullet' that can eliminate cancer cells all together. It is hoped with such advances that more people will be able to live life to its fullest, while still not having too many side effects. It is crucial for oncologists and other physicians who treat patients to know when to stop treatment as more people live longer in different ways." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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