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ALK Inhibitor

Lorlatinib + Chemotherapy for Non-Small Cell Lung Cancer (NSCLC Trial)

Phase 2

Waitlist Available

Research Sponsored by SCRI Development Innovations, LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 26 months

Awards & highlights

NSCLC Trial Summary

This trial is studying the safety and effectiveness of lorlatinib combined with chemotherapy to treat ALK+ NSCLC.

Eligible Conditions

Lung Cancer
Non-Small Cell Lung Cancer

NSCLC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 26 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse and serious adverse events of lorlatinib in combination with standard of care platinum-based chemotherapy and pemetrexed as assessed by CTCAE v5.0.

Secondary outcome measures

Objective Response Rate (ORR) to assess the anti-tumor activity of treatment with lorlatinib in combination with standard of care platinum-based chemotherapy and pemetrexed.

Pharmacokinetic (PK) analysis: lowest concentration with steady state dosing interval (Css, min) of lorlatinib in combination with standard of care platinum-based chemotherapy and pemetrexed.

NSCLC Trial Design

1Treatment groups

Experimental Treatment

Group I: Lorlatinib and Platinum and PemetrexedExperimental Treatment3 Interventions

Lorlatinib will be administered by mouth daily plus Pemetrexed by IV infusion every 3 weeks until progression or intolerable toxicity. Platinum-based standard of care chemotherapy by IV infusion will also be given every 3 weeks for the first 4 cycles; carboplatin or cisplatin are the platinum agents that may be selected based on physician discretion. One cycle is defined as 3 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lorlatinib

2018

Completed Phase 4

~440

Cisplatin or Carboplatin

2015

Completed Phase 2

~90

Pemetrexed

2014

Completed Phase 3

~5250

Do I qualify?Apply below to find out

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Who is running the clinical trial?

SCRI Development Innovations, LLCLead Sponsor

191 Previous Clinical Trials

13,563 Total Patients Enrolled

PfizerIndustry Sponsor

4,567 Previous Clinical Trials

10,911,874 Total Patients Enrolled

Melissa Johnson, MDStudy ChairSCRI Development Innovations, LLC

6 Previous Clinical Trials

882 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks should be taken into account when considering a Lorlatinib, Platinum and Pemetrexed regimen?

"The safety of Lorlatinib and Platinum and Pemetrexed has been evaluated by our team at Power, receiving a score of 2 due to the presence of initial data indicating its capacity for security, yet lacking any evidence in regards to efficacy."

Answered by AI

Are there still opportunities to enroll in this investigation?

"As per clinicaltrials.gov, this trial is presently enlisting patients to take part in the research. The first posting was made on September 1st 2023 and it has been revised most recently on September 20th of the same year."

Answered by AI

What is the numerical limit to those who can participate in this experimental endeavor?

"That is accurate. According to clinicaltrials.gov, this study opened on September 1st 2023 and has recently been updated as of the twentieth day in September 2023. 15 volunteers are needed from a single medical centre for participation in the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948462.

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