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Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in Non-small Cell Lung Cancer (NSCLC)

A Randomized Phase II Study of Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy for Advance Non-small Cell Lung Cancer(NSCLC)

NCT01137968•Geron Corporation

View on ClinicalTrials.gov

Summary

The purpose of this is to evaluate the efficacy and safety of imetelstat (GRN163L) as maintenance therapy for patients with advanced stage NSCLC who have not progressed after 4 cycles of platinum based therapy. Participants will be randomized in a 2:1 ratio to imetelstat + standard of care versus standard of care alone. Participants who received bevacizumab with their induction chemotherapy will continue to receive bevacizumab on this study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Signed informed consent.
•Ability and willingness to comply with requirements of the study protocol.
•Male or female, age 18 or over.
•Histologically or cytologically confirmed diagnosis of NSCLC
•Stage IV (using the 7th edition of AJCC, or wet IIIb / IV using the 6th edition), or recurrent locally advanced disease not amenable to radiation or surgery with curative intent and not amenable to concurrent chemoradiation.
•Patients have completed four to six cycles of platinum-based chemotherapy doublet for first line, advanced NSCLC, with no evidence of disease progression according to RECIST version 1.1. Adjuvant chemotherapy greater than one year prior to progression is allowed.
•Patients are willing and able to continue treatment with bevacizumab, if they received it with their platinum based chemotherapy.
•ECOG performance status 0-1
•Adequate bone marrow reserve as measured by ANC ≥ 1500/mm3, hemoglobin
•≥ 9 g/dL, platelet count ≥ 75,000 μL. Must be measured ≥ 1 week after last transfusion of blood products and/or last dose of hematopoietic growth factor.
+10 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from screening and study entry:
•Patients who have received, or are scheduled to receive pemetrexed or erlotinib as maintenance therapy.
•Patients receiving bevacizumab must not have a recent history of hemoptysis ≥ ½ teaspoon of red blood or history of ≥ 2 g/24 hr urine protein while receiving prior bevacizumab, or squamous cell histology.
•Patients will be excluded from being randomized if any of the following criteria apply:
•Last dose of induction chemotherapy \< 21 days prior to randomization or \> 42 days prior to randomization
•History of pulmonary hemorrhage (\> 1 teaspoon) within the 4 weeks prior to randomization.
•Anti-platelet therapy within 2 weeks prior to randomization, other than low dose aspirin prophylaxis therapy.
•Therapeutic anticoagulation therapy except for low dose warfarin (e.g., 1 mg by mouth per day).
•Radiation therapy within 3 weeks prior to randomization (palliative radiation therapy is allowed, provided that sites of bone marrow production, i.e. iliac crests are not in the radiation field)
•Major surgery within 4 weeks prior to first study drug administration (central line placement is allowed)
+14 more criteria

Locations (33)

Achieve Clinical Research, Llc

Birmingham, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Cancer Care Associates of Fresno Medical Group Inc

Fresno, California, United States

St. Joseph's Hospital

Orange, California, United States

Kaiser Permanente Medical Center

Vallejo, California, United States

University of Colorado Denver School of Medicine

Aurora, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

Integrated Community Oncology Network

Jacksonville, Florida, United States

H. Moffitt Lee Cancer Center

Tampa, Florida, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

January 26, 2016

Enrollment

116

ACTUAL participants

Conditions

Non-small Cell Lung Cancer

Interventions

imetelstat

DRUG

Bevacizumab

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

View study

RECRUITINGPHASE3

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)

NCT06305754

Non-small Cell Lung Cancer (NSCLC)

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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: January 26, 2016Data 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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Imetelstat as Maintenance Therapy After Initial Induction Chemotherapy in 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)