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Chemotherapy

High-Dose Radiation + Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Phase 3

Recruiting

Led By Charles B Simone

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of identified primary tumor and at least one nodal metastasis

Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

Study Summary

This trial tests if adding radiation & chemo plus immunotherapy to standard treatment can treat non-small cell lung cancer more effectively.

Who is the study for?

Adults aged 18+ with stage II or III non-small cell lung cancer (NSCLC) that can't be surgically removed, but haven't had extensive prior treatment. They must have a performance status indicating they're still fairly active and able to care for themselves. Participants need functioning organs, no serious concurrent illnesses, and if of childbearing potential, agree to use contraception.Check my eligibility

What is being tested?

The trial is testing whether adding high-dose targeted radiation (SBRT) to the usual combination of image-guided radiation therapy (IGRT), chemotherapy drugs like cisplatin or carboplatin with paclitaxel, pemetrexed or etoposide, followed by immunotherapy drug durvalumab improves outcomes in inoperable NSCLC compared to standard treatment alone.See study design

What are the potential side effects?

Possible side effects include damage to surrounding healthy tissue from radiation; nausea, kidney issues from platinum-based chemo drugs; nerve problems from paclitaxel; immune-related reactions from durvalumab such as inflammation in various organs; fatigue and blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread to at least one lymph node.

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My lung fluid buildup is not due to cancer.

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My blood counts are good enough for chemotherapy and radiation.

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I can take care of myself and perform daily activities.

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My cancer has EGFR or ALK mutations.

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I am 18 years old or older.

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My primary tumor is 7 cm or smaller.

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My lung cancer is stage II or III and I know my PD-L1 status.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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

Overall Survival (OS)

Progression-Free Survival (PFS)

Secondary outcome measures

Changes in pulmonary function

Incidence of adverse events

Objective Response Rate (ORR)

+3 more

Other outcome measures

Functional mean lung dose

Incidence of toxicities

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)Experimental Treatment12 Interventions

Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.

Group II: Arm I (image guided RT, chemotherapy, immunotherapy)Active Control11 Interventions

Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2008

Completed Phase 2

~2240

Paclitaxel

2011

Completed Phase 4

~5380

Image Guided Radiation Therapy

2016

Completed Phase 2

~20

Pemetrexed

2014

Completed Phase 3

~5250

Carboplatin

2014

Completed Phase 3

~6670

Cisplatin

2013

Completed Phase 3

~1940

Computed Tomography

2017

Completed Phase 2

~2720

Durvalumab

2017

Completed Phase 2

~3870

Etoposide

2010

Completed Phase 3

~2440

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,378 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,262 Total Patients Enrolled

Charles B SimonePrincipal InvestigatorNRG Oncology

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05624996 — Phase 3

Lung Cancer Research Study Groups: Arm II (SBRT, image guided RT, chemotherapy, immunotherapy), Arm I (image guided RT, chemotherapy, immunotherapy)

Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05624996 — Phase 3

Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05624996 — Phase 3

Frequently Asked Questions

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

How many medical institutions are participating in the research of this trial?

"This trial is presently taking place at 5 clinical sites, including those situated in Antigo, Stevens Point and Wausau; the other two are nearby. In order to reduce any necessary travel expenses associated with participation, it may be advantageous to join a study near your current residence."

Answered by AI

Could you provide the upper limit for participants in this clinical investigation?

"Affirmative, the information hosted on clinicaltrials.gov reveals that this trial is currently welcoming volunteers; it was first posted in May 10th 2023 and has since been updated on May 31st of the same year. The research requires 474 individuals across 5 different sites to take part."

Answered by AI

What risks have been associated with the Arm II treatment plan (SBRT, image guided RT, chemotherapy, immunotherapy)?

"Our experts have evaluated Arm II (SBRT, image-guided RT, chemotherapy, immunotherapy) to be of a high level safety rating 3 due to the multiple clinical studies that demonstrate its efficacy and corroborated by numerous data points indicating its security."

Answered by AI

What are the main aims of this research endeavor?

"The chief aim of this clinical trial, which will be observed across an 8 year period from the date of randomization to the first documented instance of progression or death due to any cause, is Overall Survival (OS). Other secondary objectives include Time to primary, locoregional, or distant failure assessed using a competing risks analysis and Cumulative Incidence Function alongside log-rank test results; pulmonary function changes evaluated by Forced Expiratory Volume in 1 second (FEV1) and Diffusion Capacity for Carbon Monoxide (DLCO); Patient Reported Outcomes utilizing Functional Assessment of Cancer Therapy Lung Questionnaire Trial outcome index deterioration rates at"

Answered by AI

Are any potential participants being accepted for this experiment currently?

"Clinicaltrials.gov records indicate that this trial is actively looking for participants; the first posting of which was on May 10th 2023 and it has been updated most recently on May 31st, 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer

2023. "Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05624996.

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