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Lorlatinib Combinations in Lung Cancer

NCT04292119 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2021-03-10

No results posted yet for this study

Summary

This research study is evaluating Lorlatinib in combination with Crizotinib, Binimetinib, or TNO155 as a possible treatment for either anaplastic lymphoma kinase (ALK)-positive lung cancer or ROS1-positive lung cancer.

* This research study involves four study drugs.
* Lorlatinib
* Binimetinib
* Crizotinib
* TNO155

Conditions

  • Lung Cancer
  • Anaplastic Lymphoma Kinase Gene Translocation
  • ROS1 Rearrangement
  • Relapsed Cancer
  • MET Amplification
  • Resistant Cancer
  • NSCLC

Interventions

DRUG

Lorlatinib

Lorlatinib will be taken orally once daily for 28 days when combined with crizotinib or binimetinib. Lorlatinib will be taken orally once daily for 21 days when combined with TNO155. Crizotinib taken orally twice daily for 28 days.

DRUG

Crizotinib

Crizotinib will be taken orally twice daily for 28 days. Binimetnib taken orally twice daily for 28 days.

DRUG

Binimetinib

Binimetinib will be taken orally twice daily for 28 days.

DRUG

TNO155

TNO155 will be taken orally once daily for 14 days.

Sponsors & Collaborators

  • Array BioPharma

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ibiayi Dagogo-Jack, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-12-01
Completion
2023-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04292119 on ClinicalTrials.gov