What side effects are associated with this type of intervention?

Common side effects of immunotherapies such as pembrolizumab and atezolizumab for Non-Small Cell Lung Cancer include fatigue, rash, diarrhea, and immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies, depending on the specific agent, can cause side effects such as skin rash, diarrhea, liver enzyme abnormalities, and hypertension. Both types of treatments generally have more favorable toxicity profiles compared to conventional chemotherapy, potentially improving the quality of life for patients.

What prior FDA approvals exist?

Several immunotherapies and targeted therapies have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, an anti-PD-1 therapy, has been approved in combination with chemotherapy for both squamous and non-squamous NSCLC, showing significant improvements in overall survival (OS) and progression-free survival (PFS). Atezolizumab, another immunotherapy, has been approved in combination with bevacizumab and chemotherapy for non-squamous NSCLC, also demonstrating enhanced OS and PFS. Additionally, nivolumab combined with ipilimumab, with or without chemotherapy, is approved for advanced NSCLC irrespective of PD-L1 expression. These treatments align with the goals of the Beating Lung Cancer in Ohio protocol, which aims to evaluate therapies that prolong survival and improve quality of life.

What other types of research exist?

Promising alternatives to the Beating Lung Cancer in Ohio protocol for NSCLC patients include: 1) Pembrolizumab combined with platinum-doublet chemotherapy, which has shown improved overall survival and progression-free survival in patients with advanced nonsquamous NSCLC. 2) Nivolumab, either alone or in combination with ipilimumab, which has demonstrated improved survival and quality of life in patients with advanced NSCLC. 3) Atezolizumab combined with chemotherapy, particularly for patients with high PD-L1 expression, which has shown benefits in progression-free survival and overall survival.

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New Treatment Protocol for Advanced Lung Cancer (BLCIO Trial)

N/A

Recruiting

Led By Peter Shields, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Being treated with definitive chemoradiotherapy or surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new ways to treat advanced lung cancer using genetic and immune system tests, along with expert advice for doctors. It aims to improve survival and quality of life for patients with stage IV non-small cell lung cancer.

Who is the study for?

This trial is for English-speaking adults with stage IV non-small cell lung cancer (NSCLC), including current or recent smokers. Participants must be willing to share medical records and biospecimens, and complete questionnaires. They should not have hearing or vision impairments that would affect their participation, nor should they have been treated for advanced lung cancer for over a month before joining.

What is being tested?

The 'Beating Lung Cancer in Ohio' protocol is being tested to see if it can improve survival rates by using immunotherapies and targeted therapies instead of conventional chemotherapy. These treatments are expected to be less toxic and may positively impact the quality of life.

What are the potential side effects?

While specific side effects are not listed, immunotherapies and targeted therapies typically may cause reactions at the injection site, flu-like symptoms, fatigue, skin reactions, organ inflammation, and changes in blood counts.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently undergoing treatment with chemotherapy and radiation, or I have had surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cost-Effectiveness Analysis

Overall survival (Aim I observational phase)

Percent of patients receiving first line targeted therapy (Aim I observational phase)

+9 more

Side effects data

From 2022 Phase 3 trial • 87 Patients • NCT02066181

73%

Fatigue

71%

Palmar-plantar erythrodysesthesia syndrome

63%

Hypertension

61%

Papulopustular rash

55%

Diarrhea

51%

Nausea

39%

Myalgia

37%

Alopecia

35%

Arthralgia

33%

Abdominal pain

31%

Anorexia

27%

Vomiting

22%

Mucositis oral

22%

Constipation

18%

Anemia

18%

Alanine aminotransferase increased

16%

Platelet count decreased

14%

Pruritus

14%

Hyperglycemia

14%

Rash maculo-papular

14%

Skin and subcutaneous tissue disorders - Other, specify

12%

Aspartate aminotransferase increased

12%

Rash acneiform

12%

Peripheral sensory neuropathy

10%

Investigations - Other, specify

10%

Dry skin

10%

Neutrophil count decreased

10%

Blood bilirubin increased

Back pain

Headache

Nervous system disorders - Other, specify

Pain in extremity

General disorders and administration site conditions - Other, specify

Skin infection

White blood cell decreased

Hypercalcemia

Hypokalemia

Musculoskeletal and connective tissue disorder - Other, specify

Dizziness

Respiratory, thoracic and mediastinal disorders - Other, specify

Eye disorders - Other, specify

Hyperkalemia

Pain

Alkaline phosphatase increased

Hypocalcemia

Cough

Flushing

Tinnitus

Dental caries

Gastrointestinal disorders - Other, specify

Hemoglobin increased

Weight loss

Metabolism and nutrition disorders - Other, specify

Dysgeusia

Anxiety

Irregular menstruation

Menorrhagia

Sore throat

Lymphocyte count decreased

Hyperuricemia

Non-cardiac chest pain

Infections and infestations - Other, specify

Hypernatremia

Hypoglycemia

Scalp pain

Dry mouth

Blurred vision

Hypothyroidism

Urticaria

Hemorrhoids

Acute kidney injury

Palpitations

Leukocytosis

Myocardial infarction

Vertigo

Anal hemorrhage

Dysphagia

Esophageal pain

Periodontal disease

Fever

Sinusitis

Urinary tract infection

Bruising

Dermatitis radiation

Cholesterol high

Creatinine increased

Neck pain

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Concentration impairment

Memory impairment

Spasticity

Depression

Insomnia

Allergic rhinitis

Productive cough

Sleep apnea

Pregnancy, puerperium and perinatal conditions - Other, specify

Dry eye

Lymphedema

Chest pain - cardiac

Heart failure

Gastric perforation

Hypertriglyceridemia

Dyspnea

Cardiac disorders - Other, specify

Gastroesophageal reflux disease

Oral dysesthesia

Chills

Hypophosphatemia

Chest wall pain

Psychiatric disorders - Other, specify

Hematuria

Urinary tract obstruction

Dysmenorrhea

Skin hypopigmentation

Unintended pregnancy

Flu like symptoms

Nail infection

Pancreatitis

Blood and lymphatic system disorders - Other, specify

Oral pain

Fall

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Sorafenib Tosylate)

Arm II (Placebo)

Crossover Group

Awards & 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 II (AGIT/DS)Experimental Treatment6 Interventions

Patients undergo collection of tumor tissue for analysis using FoundationOne assay and blood sample for analysis using FoundationACT blood circulating tumor DNA assay. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

Group II: Arm I (UC)Active Control7 Interventions

Patients receive usual care and undergo collection of tumor tissue and blood sample for the repository. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2020

Smoking Cessation Intervention

2005

N/A

~1800

0 / 1Eligibility criteria met

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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies and targeted therapies. Immunotherapies, such as PD-1/PD-L1 inhibitors, enhance the immune system's ability to recognize and attack cancer cells by blocking proteins that allow cancer cells to evade immune detection. Targeted therapies involve drugs that specifically target genetic mutations or proteins essential for cancer cell growth and survival, such as EGFR inhibitors for EGFR mutations and ALK inhibitors for ALK rearrangements. These treatments are significant for NSCLC patients as they provide more personalized and effective options, potentially improving survival rates and quality of life with fewer side effects compared to traditional chemotherapy.

Emerging therapeutic agents for lung cancer.