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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 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
~140
Pemetrexed
2014
Completed Phase 3
~5250

Find a Location

Who is running the clinical trial?

SCRI Development Innovations, LLCLead Sponsor
191 Previous Clinical Trials
13,563 Total Patients Enrolled
PfizerIndustry Sponsor
4,582 Previous Clinical Trials
14,634,797 Total Patients Enrolled
Melissa Johnson, MDStudy ChairSCRI Development Innovations, LLC
6 Previous Clinical Trials
882 Total Patients Enrolled
~0 spots leftby Mar 2025
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