← Back to Search

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
Must not have
Participants who are pregnant or unwilling to discontinue nursing
Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

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
Select...
My cancer has spread to at least one lymph node.
Select...
My lung fluid buildup is not due to cancer.
Select...
My blood counts are good enough for chemotherapy and radiation.
Select...
I can take care of myself and perform daily activities.
Select...
My cancer has EGFR or ALK mutations.
Select...
I am 18 years old or older.
Select...
My primary tumor is 7 cm or smaller.
Select...
My lung cancer is stage II or III and I know my PD-L1 status.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant and not nursing.
Select...
I do not have cancer that started in an unknown place with a swollen lymph node.
Select...
My main tumor is very close to the affected lymph nodes.
Select...
I've had radiation in the same area as my current cancer.

Timeline

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
~2210
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
~3840
Etoposide
2010
Completed Phase 3
~2440
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Stereotactic Body Radiation Therapy (SBRT) is a high-precision radiation treatment that targets lung cancer tumors with high doses of radiation over fewer sessions, minimizing damage to surrounding healthy tissue. This precision is crucial for lung cancer patients as it reduces side effects and improves the quality of life while effectively controlling tumor growth. Chemotherapy, using drugs like cisplatin and carboplatin, works by killing or inhibiting the growth of rapidly dividing cancer cells, but it can also affect normal cells, leading to broader side effects. Immunotherapy, such as durvalumab, enhances the body's immune response against cancer cells, offering a targeted approach that can lead to prolonged survival. Combining these treatments can provide a comprehensive approach to managing lung cancer, balancing efficacy with quality of life.
Stereotactic body radiotherapy for centrally located early-stage non-small cell lung cancer or lung metastases from the RSSearch(®) patient registry.

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor
232 Previous Clinical Trials
100,275 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,927 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
~316 spots leftby Oct 2031