Stereotactic Body Radiation Therapy for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Adenocarcinoma+16 More
Stereotactic Body Radiation Therapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the addition of radiation therapy to the usual immunotherapy (with or without chemotherapy) treatment for patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) and who are also negative for a molecular marker called PD-L1.

Eligible Conditions
  • Adenocarcinoma
  • Non-Small Cell Lung Carcinoma
  • Stage IIIC Lung Cancer AJCC v8
  • Stage IVA Lung Cancer AJCC v8
  • Stage IIIB Lung Cancer AJCC v8
  • Advanced Lung Adenocarcinoma
  • Lung
  • Adenosquamous carcinoma
  • Metastatic Lung Adenocarcinoma
  • Malignant Neoplasms
  • Stage IVB Lung Cancer AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 5 years

Year 5
Overall survival (OS) (Phase III)
Year 5
PFS
Progression-free survival (PFS) (Phase II)
Up to 5 years
Incidence of treatment-related adverse events
Objective response rate (ORR)
Quality of life

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Treatment (Chemotherapy, Oregovomab, SBRT, Surgery)
55%Leukopenia
36%Thrombocytopenia
36%Lymphopenia
18%Reduced ANC
18%AST elevation
18%ALT elevation
18%Anemia
9%Orthostasis
9%Nausea
9%Dehydration
9%Acidosis
9%Cardiac disorders
9%Hypokalemia
9%Hyperkalemia
9%Pancreatitis
9%Sepsis
9%Rash
9%Vomiting
9%Sinusitis
9%Depression
9%Pneumonia
9%Urinary tract infection
9%Pleural effusion
9%Somnolence
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01959672) in the Treatment (Chemotherapy, Oregovomab, SBRT, Surgery) ARM group. Side effects include: Leukopenia with 55%, Thrombocytopenia with 36%, Lymphopenia with 36%, Reduced ANC with 18%, AST elevation with 18%.

Trial Design

2 Treatment Groups

Arm A (immunotherapy, +/- chemotherapy)
1 of 2
Arm B ( immunotherapy, +/- chemotherapy, SBRT)
1 of 2
Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Body Radiation Therapy · No Placebo Group · Phase 2 & 3

Arm A (immunotherapy, +/- chemotherapy)Experimental Group · 8 Interventions: Carboplatin, Nab-paclitaxel, Paclitaxel, Pemetrexed, Pembrolizumab, Ipilimumab, Quality-of-Life Assessment, Nivolumab · Intervention Types: Drug, Drug, Drug, Drug, Biological, Biological, Other, Biological
Arm B ( immunotherapy, +/- chemotherapy, SBRT)Experimental Group · 9 Interventions: Carboplatin, Nab-paclitaxel, Paclitaxel, Pemetrexed, Pembrolizumab, Ipilimumab, Quality-of-Life Assessment, Stereotactic Body Radiation Therapy, Nivolumab · Intervention Types: Drug, Drug, Drug, Drug, Biological, Biological, Other, Radiation, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Albumin human
FDA approved
Paclitaxel
FDA approved
Pemetrexed
FDA approved
Pembrolizumab
FDA approved
Ipilimumab
FDA approved
Stereotactic Body Radiation Therapy
2016
Completed Phase 2
~590
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,297,538 Total Patients Enrolled
408 Trials studying Adenocarcinoma
79,435 Patients Enrolled for Adenocarcinoma
Steven E SchildPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory
You have measurable disease based on RECIST 1.1, including at least two cancerous deposits.
You have a histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: October 28th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.