What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving immune checkpoint inhibitors like Durvalumab (PD-L1 inhibitor) and combination therapies with chemotherapy have several known side effects. Immune checkpoint inhibitors can cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Combination therapies with chemotherapy can lead to additional side effects including nausea, fatigue, anemia, neutropenia, and increased risk of infections. The severity of these side effects can vary, with some patients experiencing grade 3 or higher adverse events, which are more severe and may require discontinuation of treatment.

What prior FDA approvals exist?

Several PD-1/PD-L1 inhibitors have received FDA approval for the treatment of NSCLC. Pembrolizumab (Keytruda) is approved for use in combination with chemotherapy for both squamous and non-squamous NSCLC, showing improved overall survival and progression-free survival. Atezolizumab (Tecentriq) is another PD-L1 inhibitor approved for use with chemotherapy in non-squamous NSCLC, also demonstrating significant benefits in survival outcomes. Cemiplimab (Libtayo) is approved for advanced NSCLC with high PD-L1 expression. These approvals highlight the effectiveness of combining immunotherapy with chemotherapy in treating NSCLC.

What other types of research exist?

Promising alternatives to Durvalumab for NSCLC patients include Pembrolizumab and Nivolumab, both of which are PD-1 inhibitors with demonstrated efficacy in various NSCLC subtypes. Atezolizumab, another PD-L1 inhibitor, is also a viable option. Additionally, targeted therapies such as Lorlatinib for ALK-positive NSCLC, Alectinib for crizotinib-resistant ALK-rearranged NSCLC, and Osimertinib for EGFR-mutated NSCLC are promising novel treatments. These alternatives have shown significant efficacy and safety profiles in clinical trials.

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PD-L1 Inhibitor

Durvalumab + Radiation for Lung Cancer

Phase 2

Recruiting

Led By Charles Simone, MD

Research Sponsored by Memorial Sloan Kettering 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining the drug durvalumab with a precise radiation treatment is more effective for early-stage lung cancer patients than using the radiation treatment alone. Durvalumab has shown promise in improving survival rates in advanced lung cancer patients and is being tested in various combinations, including with radiation therapy.

Who is the study for?

This trial is for adults with early-stage non-small cell lung cancer who can't or choose not to have surgery. They should be in good physical condition, weigh over 30kg, and have a life expectancy of at least 12 weeks. Patients must not have certain mutations, autoimmune diseases, severe illnesses, or previous treatments that could interfere with the study.

What is being tested?

The study is testing if combining durvalumab (a drug) with stereotactic body radiation therapy (SBRT) works better than SBRT alone for treating early-stage non-small cell lung cancer. Participants will receive both the drug and radiation to see if this improves their treatment outcomes.

What are the potential side effects?

Durvalumab may cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems (like thyroid), fatigue, nausea and potential infusion-related reactions. Radiation therapy might lead to skin irritation and fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Progression Free Survival

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129

65%

Fatigue

63%

Abdominal pain

55%

Diarrhea

43%

Pain

40%

Weight loss

35%

Hypertension

30%

Anorexia

30%

Constipation

28%

Nausea

28%

Pruritus

25%

Vomiting

20%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Early-stage Non-Small Cell Lung CancerExperimental Treatment2 Interventions

Participants will be diagnosed with Stage I-IIIA NSCLC and will be ineligible for surgery and will have any level of PD-L1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790

Do I qualify?Apply below to find out

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, chemotherapy, and targeted therapies. Immunotherapies like Durvalumab, a PD-L1 inhibitor, work by blocking the interaction between PD-L1 on tumor cells and PD-1 on T-cells, thereby enhancing the immune system's ability to attack cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cancer cells, while targeted therapies focus on specific genetic mutations within cancer cells, such as EGFR or ALK mutations, to inhibit their growth. These treatments are crucial for NSCLC patients as they offer different mechanisms to control and potentially eradicate the cancer, improving survival rates and quality of life.