Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07415005
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lorlatinib — DRUG
    Given Orally

Study Details

This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.

Key Dates

Start date
Apr 24, 2026
Status verified
Apr 2026
Primary completion
Jul 22, 2028
Completion
Jul 22, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: G1_LLT: Phase 2 Group 1 Mono Treatment with Lorlatinib
    All patients will receive lorlatinib orally daily for an induction period of 12 weeks prior to randomization, for patients treated for another first line ALK TKI for 4 weeks or less and switched to lorlatinib, they will receive lorlatinib up to a total time of 12 weeks on an ALK TKI pre-randomization.
  • Experimental: G2_LLT+LCT: Phase 2 Group 2 Combo Treatment with Lorlatinib+Local Consolidation Therapy (LCT)
    All patients will receive lorlatinib orally daily for an induction period of 12 weeks prior to randomization, for patients treated for another first line ALK TKI for 4 weeks or less and switched to lorlatinib, they will receive lorlatinib up to a total time of 12 weeks on an ALK TKI pre-randomization.

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Yasir Y Elamin, MD
[email protected]
713-792-3428
Yasir Y Elamin, MD (PRINCIPAL_INVESTIGATOR)

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By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

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