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Monoclonal Antibodies

Durvalumab + SBRT for Non-Small Cell Lung Cancer (358 Trial)

Phase 2

Waitlist Available

Led By Hina Khan, MD

Research Sponsored by Hina Khan

Eligibility Criteria Checklist

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

Must have

Stage III NSCLC

Age > 18 years

Must not have

Disease progression during or after standard chemoradiation

Metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of two treatments, Durvalumab and stereotactic body radiation therapy (SBRT), to see if it is more effective in fighting lung cancer than Durvalumab alone.

Who is the study for?

This trial is for adults over 18 with Stage III Non-Small Cell Lung Cancer who've completed chemoradiation but haven't progressed. They must have finished treatment within 3-7 weeks, have a tumor under 120cc suitable for SBRT, and meet certain blood and organ function criteria. Participants need to agree to use contraception and not be pregnant.

What is being tested?

The study tests combining Durvalumab, an immune system-stimulating drug approved for lung cancer, with SBRT—a high-dose radiation therapy focused on the tumor. This combination is investigational in stage III patients to see if it's more effective post-chemoradiation.

What are the potential side effects?

Durvalumab may cause immune-related reactions affecting organs, fatigue, infusion reactions like fever or chills, and increase infection risk. SBRT can lead to localized skin irritation or damage to nearby tissues due to its targeted high radiation doses.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer is at stage III.

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I am older than 18 years.

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I completed treatment combining chemotherapy and radiation, receiving a radiation dose between 50-65 Gy.

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My remaining tumor is small enough for targeted radiation therapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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My condition worsened despite receiving chemoradiation.

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My cancer has spread to other parts of my body.

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I do not have severe health issues like uncontrolled nerve pain, recent heart problems, serious liver disease, very low HIV immunity, recent use of strong immune system drugs, active tuberculosis, allergy to Durvalumab, active autoimmune disease treated in the last 2 years, significant lung inflammation, current serious infection needing IV treatment, or active Hepatitis B or C.

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I have had chest radiation before, not including treatment before SBRT.

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My doctor confirms I have a severe illness that is not under control.

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I haven't had chemotherapy in the last 3 weeks.

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I have been treated with immune checkpoint inhibitors before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months for 1 year then every 4 months for two years then every 6 months for two years then annually until progression on average for about 5 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

Average progression-free survival of chemoradiation followed by SBRT and durvalumab for patients with locally advanced stage III NSCLC.

Number of patients experiencing grade 2 or higher toxicities during consolidation SBRT with concurrent durvalumab after chemoradiation for locally advanced stage III NSCLC

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: Durvalumab and SBRTExperimental Treatment2 Interventions

Durvalumab 10mg/kg x 1 day, dose #1 to occur \> 3 weeks and \<7 weeks after last chemo/RT and prior to SBRT dose 1 (5-10 day time frame between Durvalumab and SBRT). SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab (see above for time frames). The dose will consist of 20Gy (2 fractions of 10Gy). 3 fractions are allowed for centrally located tumors Dose # 2 of durvalumab, (post SBRT) to be given 1-10 days post last SBRT. Durvalumab then to be given at 10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

SBRT

2014

Completed Phase 2

~1060