Lorlatinib for Non-Small Cell Lung Cancer

Recruiting at 50 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Pfizer

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to learn whether the study medicine (called lorlatinib) is safe and effective for the treatment of non-small cell lung cancer that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene. This study is seeking participants whose lung cancer has progressed after receiving either alectinib or ceritinib as their first treatment. Participants will take part in this study for up to approximately 4 years, depending on when the study is completed and how their cancer responds to the study treatment. They will take lorlatinib orally (by mouth) once daily. Participants will visit the study site about every six weeks to meet with the study team. During these visits, the study team will monitor the safety and effects of lorlatinib.

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

This trial is for people with ALK-positive non-small cell lung cancer that worsened after treatment with alectinib or ceritinib. Participants should have manageable side effects from previous treatments, at least one measurable lung lesion, and be in good physical condition (ECOG 0-1). They must not be pregnant or breastfeeding and agree to use contraception. People can't join if they've had certain heart conditions, other recent cancers, severe allergies to the drug's components, or are unable to take oral medication.

Inclusion Criteria

I am fully active or can carry out light work.

My lung cancer is stage IV with an ALK rearrangement.

I have a measurable tumor outside the brain and may have stable brain metastases.

Exclusion Criteria

I haven't had any cancer other than my current NSCLC or certain low-risk types in the last 3 years.

I haven't had radiation therapy (except for bone pain relief) in the last 2 weeks.

Known prior or suspected severe hypersensitivity to study interventions or any component in their formulations.

Treatment Details

Interventions

• Lorlatinib (ALK Inhibitor)

Trial Overview The study tests Lorlatinib's safety and effectiveness in treating ALK-positive non-small cell lung cancer over up to four years. Patients will take Lorlatinib daily by mouth and visit the study site every six weeks for monitoring. The trial includes those who saw their cancer progress after initial treatment with either alectinib or ceritinib.

Participant Groups

Group I: Lorlatinib Experimental Treatment 1 Intervention

Participants will take 100 mg (four, 25 mg tablets) once daily.

Lorlatinib is already approved in Japan, Canada for the following indications:

Approved in Japan as Lorbrena for:

• Unresectable, advanced/recurrent non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement

Approved in Canada as Lorbrena for:

• Metastatic non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University