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Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

A Phase I/II Study of Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

NCT03087448•University of California, San Francisco

View on ClinicalTrials.gov

Summary

This is a phase I/II study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase (ALK) rearranged non-small cell lung cancer (NSCLC). The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC. The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts: ALKi (ALK inhibitor) naïve patients; post-crizotinib progressed disease (PD) patients; and PD second line ALK tyrosine kinase inhibitor (TKI) patients.

Detailed Description

This was intended to be a phase I/II study of ceritinib and trametinib in Stage IIIB or IV ALK rearranged NSCLC. The phase I portion is a standard 3+3 dose escalation study starting at dose level 1 and will be open to any patient with ALK-rearranged, or ROS-1 rearranged NSCLC. The study was terminated before Phase II was initiated. The study did not open Phase II for enrollment into the planned cohorts: * Cohort A (ALKi Naïve) * Cohort B (Post-crizotinib PD) * Cohort C (PD second line ALK TKI (e.g., alectinib, ceritinib, PF-06463922 or - AP21163) Only participants in Phase 1 were enrolled. Patients may continue treatment for up to 24 months from the time of study entry, and will receive 12 months of follow-up following completion of the drugs.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 years old or older.
•2. Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
•3. Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to Cycle 1 Day 1 and agree to use effective contraception, throughout the treatment period, and for 4 months after the last dose of study treatment.
•.
•4. Patients must have histologically or cytological confirmed stage IIIB or IV non-small cell lung cancer.
•5. Documented ALK-rearrangement (or ROS1 rearrangement for phase I only) break-apart fluorescence in situ hybridization (FISH) (in at least 15% of tumor cells), or next generation sequencing assay performed on tumor sample or cell-free DNA in Clinical Laboratory Improvement Amendments (CLIA)-approved laboratory.
•6. Measurable disease defined by RECIST 1.1 criteria
•7. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2.
•8. Life expectancy of at least 3 months.
•9. Resolution of all acute toxic effects of prior chemotherapy, immunotherapy, radiotherapy or surgical procedures to ≤ grade 2 (CTCAE v 4.0). Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment.
+25 more criteria

Exclusion Criteria

•1. Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate).
•2. Patient has history of interstitial lung disease or interstitial pneumonitis, including clinically significant radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention).
•3. Patient who has received thoracic radiotherapy to lung fields ≤4 weeks prior to starting the study treatment or patients who have not recovered from radiotherapy-related toxicities. For all other anatomic sites (including radiotherapy to thoracic vertebrae and ribs) radiotherapy ≤2 weeks prior to starting the study treatment or has not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting study treatment is allowed.
•4. Prior systemic anti-cancer treatment (chemotherapy, immunotherapy, biologic therapy, vaccine therapy, or investigational treatment) within the last 3 weeks, or chemotherapy without delayed toxicity within the last 2 weeks preceding the first dose of the combination. Prior systemic treatment in the adjuvant setting is allowed.
•5. Patient has clinically significant, uncontrolled heart disease and/or recent cardiac event (within 6 months), such as:
•* unstable angina within 6 months prior to screening;
•* myocardial infarction within 6 months prior to screening;
•* history of documented congestive heart failure (New York Heart Association functional classification III-IV);
•* Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or without antihypertensive medication
•* initiation or adjustment of antihypertensive medication(s) is allowed prior to screening;
+32 more criteria

Locations (2)

University of California, Davis

Davis, California, United States

University of California, San Francisco

San Francisco, California, United States

Key Dates

Start Date

September 9, 2017

Primary Completion Date

April 30, 2022

Completion Date

April 30, 2022

Last Updated

December 27, 2022

Enrollment

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

Ceritinib

DRUG

Trametinib

DRUG

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

NCT07190248

Non-small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)