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Anti-metabolites

Arm 2 (SBRT + maintenance chemotherapy) for Non-Small Cell 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

Study 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.Check my eligibility

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.See study design

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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase II - Progression-Free Survival (PFS)

Phase III - Overall Survival (OS)

Secondary outcome measures

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 more

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

Pemetrexed Disodium

2015

Completed Phase 2

~280

Pembrolizumab

2017

Completed Phase 2

~2010

Docetaxel

1995

Completed Phase 4

~5620

Gemcitabine

2017

Completed Phase 3

~2070

Erlotinib Hydrochloride

2010

Completed Phase 2

~2850

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,634 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,223 Total Patients Enrolled

Puneeth IyengarPrincipal InvestigatorNRG Oncology

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for individuals to participate in this research?

"As indicated on clinicaltrials.gov, this research is no longer recruiting patients; the trial was originally posted in April 2017 and updated most recently in December 2023. However, 1938 other medical trials are actively looking for participants at present."

Answered by AI

What number of medical facilities are now carrying out this clinical trial?

"There are 306 sites where this clinical trial is running, including West virginia University Healthcare in Morgantown, Langlade Hospital and Cancer Center in Antigo, and Lancaster General Ann B Barshinger Cancer Institute in Lancaster. Additionally there numerous other locations participating."

Answered by AI

What is the current regulatory status of Arm 2 (SBRT + maintenance chemotherapy)?

"Although Phase 2 trials have only provided evidence of safety, our team at Power believes that Arm 2 (SBRT + maintenance chemotherapy) is relatively secure and assigned it a score of two."

Answered by AI

What are the stated objectives of this experiment?

"The primary objective of this Phase III trial is to monitor Overall Survival. Secondary endpoints include the Time to Development of New Lesions, Time to In-Field Failure, and Incidence of Adverse Events graded per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5. These measurements will be taken over a three year period on an intent-to-treat basis from randomization until documented progression or death due to any cause occurs first."

Answered by AI