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Lorlatinib for Non-Small Cell Lung Cancer

UC Irvine Health, Orange, CA
Non-Small Cell Lung CancerLorlatinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will provide continued lorlatinib treatment and safety monitoring to those who benefit from it, to further understand its safety profile.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

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Copanlisib
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Lorlatinib

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline up to approximately 5 years

Year 5
Number of participants with adverse events leading to permanent discontinuation of study intervention
Number of serious adverse events reported for all participants

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Copanlisib
1
Copanlisib
1
Lorlatinib

Side Effects for

Mild Impairment
13%Blood pressure increased
13%Vessel puncture site pain
13%Myalgia
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%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1 Treatment Group

Lorlatinib
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: Lorlatinib · No Placebo Group · Phase 4

Lorlatinib
Drug
Experimental Group · 1 Intervention: Lorlatinib · Intervention Types: Drug
Treatment
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: baseline up to approximately 5 years

Who is running the clinical trial?

PfizerLead Sponsor
4,396 Previous Clinical Trials
25,774,832 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,340 Previous Clinical Trials
23,427,435 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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References

Frequently Asked Questions

What is the capacity of this experiment in terms of participants?

"Affirmative. Clinicaltrials.gov displays that this medical trial, which appeared on December 28th 2021 remains active and is currently recruiting participants. 200 individuals are being enrolled from a single medical centre." - Anonymous Online Contributor

Unverified Answer

Could you please elucidate the potential risks associated with Lorlatinib?

"Lorlatinib has already been approved by the FDA, so its safety level is rated a 3." - Anonymous Online Contributor

Unverified Answer

Is this clinical research program currently enrolling participants?

"According to information hosted on clinicaltrials.gov, enrollment is presently ongoing for this medical trial which was first publicized on December 28th 2021 and last revised on February 22nd 2023." - Anonymous Online Contributor

Unverified Answer

Does this clinical research represent a pioneering effort?

"Presently, 17 trials for Lorlatinib are being conducted in 440 cities and 26 nations. The pioneer investigation of this drug occurred in 2016 when Amgen sponsored a trial with 1550 participants which eventually culminated in Phase 2 FDA clearance. Since then, 12 such studies have been completed." - Anonymous Online Contributor

Unverified Answer

Has any other experimentation been done with Lorlatinib?

"Currently, there are 17 ongoing lorlatinib clinical trials with 1 in the third stage of testing. Broadly based out of Boston, Massachusetts these tests can be found at 901 different medical sites around the world." - 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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