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Anti-metabolites
Maintenance Chemotherapy for Lung Cancer
Phase 2
Waitlist Available
Led By Puneeth Iyengar
Research Sponsored by NRG Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance ≥ 45 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Imaging proof of limited metastatic disease and response to therapy/stable disease, by at least CT chest through the adrenals or PET/CT within 30 days prior to registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying giving maintenance chemotherapy with or without local consolidation therapy to see if it works better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer who are in good general health and have responded to or have stable disease after initial therapy. They must be able to follow the study plan, use contraception if they can have children, and meet specific blood test and organ function criteria.
What is being tested?
The trial is testing whether adding local consolidation therapy (like radiation) to maintenance chemotherapy improves outcomes for patients with advanced lung cancer. Chemotherapy drugs like docetaxel and pemetrexed disodium aim to stop tumor growth by killing or preventing the division of cancer cells.
What are the potential side effects?
Possible side effects include fatigue, nausea, hair loss from chemotherapy drugs like docetaxel; skin reactions from radiation therapy; liver enzyme changes; low white blood cell counts which can increase infection risk; kidney function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is sufficient, with a creatinine clearance rate of at least 45 mL/min.
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My scans show limited spread of cancer and it's not getting worse.
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I can take care of myself and am up more than 50% of my waking hours.
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My lung cancer has spread to other parts of my body.
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My liver enzymes are within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase II - Progression-Free Survival (PFS)
Phase III - Overall Survival (OS)
Secondary study objectives
Duration of Maintenance Chemotherapy Usage
Incidence of adverse events graded per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5
Time to Development of New Lesions
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (SBRT + maintenance chemotherapy)Experimental Treatment8 Interventions
Patients undergo LCT over 2-4 weeks. If LCT cannot be used to treat primary disease sites, patients also undergo IMRT or 3DCRT over 3-5 weeks. Within 2 weeks after completion of radiation therapy, patients receive chemotherapy as in Arm 1. Patients may possibly undergo surgery.
Group II: Arm 1 (maintenance chemotherapy)Active Control5 Interventions
Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride PO QD, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Gemcitabine
2017
Completed Phase 3
~1920
Stereotactic Body Radiation Therapy (SBRT)
2018
Completed Phase 2
~950
Pemetrexed Disodium
2015
Completed Phase 2
~450
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900
Pembrolizumab
2017
Completed Phase 3
~3150
Find a Location
Who is running the clinical trial?
NRG OncologyLead Sponsor
238 Previous Clinical Trials
102,877 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,921 Total Patients Enrolled
Puneeth IyengarPrincipal InvestigatorNRG Oncology
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