Durvalumab and Consolidation SBRT Following Chemoradiation for Locally Advanced Stage III Non-Small Cell Lung

  • STATUS
    Recruiting
  • End date
    Oct 23, 2025
  • participants needed
    25
  • sponsor
    Hina Khan
Updated on 23 January 2021
Investigator
Roxanne Wood, BA
Primary Contact
The Miriam Hospital (2.3 mi away) Contact
+1 other location

Summary

Durvalumab is a drug that stimulates the immune system to fight lung cancer. Durvalumab is FDA approved to treat lung cancer. Stereotactic body radiation therapy (SBRT) is a newer radiation treatment that gives fewer, but higher doses of radiation than standard radiation.

With SBRT, radiation is focused toward the cancer and away from normal surrounding lung tissue. It is possible that when cancer cells are damaged by SBRT Durvalumab may be more effective in activating the immune system. SBRT is a standard FDA approved treatment for early stage (stage 1) lung cancer and is investigational in patients such as yourself with stage 3 lung cancer. The combination of Durvalumab and SBRT is investigational. This study will investigate the effects, good and bad, of the combination of Durvalumab and SBRT.

Details
Condition Stage III Non-small-cell Lung Cancer, Stage III Non-small-cell Lung Cancer
Treatment SBRT, durvalumab
Clinical Study IdentifierNCT03589547
SponsorHina Khan
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Stage III NSCLC
Completion of concurrent chemoradiation
Radiation dose of 60.0 Gy (50-65Gy) using standard fractionation
Patients will receive the first dose of durvalumab > 3 weeks and < 7 weeks after their last treatment of chemoradiation (last radiation or chemotherapy treatment, whichever ended last).Sites are required to submit prior treatment (chemotherapy and radiation)
Residual tumor volume that is appropriate for SBRT
Residual Primary tumor <120cc (approximately 6cm diameter)
Absolute neutrophil count 1,000/uL, platelet 60,000/uL prior to registration
Total bilirubin 1.5x upper institutional limit of normal (ULN), and AST and ALT 3x ULN
ECOG performance status 0 to 1
Minimum life expectancy of 12 weeks as determined by treating physician
Age > 18 years
Voluntary, signed written informed consent
Women of childbearing potential must have a negative serum pregnancy test within 7 days of day 1 of treatment (post-menopausal women, defined as surgical menopause or lack or menses >12 months, do not need to have a pregnancy test, document status.)
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 6 months after the last treatment
Resolution of all related toxicities from chemo/RT to < grade 2, except alopecia
Patient must have tissue available from prior biopsy for correlative studies as confirmed by treating physician

Exclusion Criteria

Disease progression during or after standard chemoradiation
Prior thoracic radiation (other than the chemoradiation delivered prior to SBRT)
Metastatic disease
Uncontrolled severe, intercurrent illness as confirmed by the treating physician
Chemotherapy within 3 weeks from the first treatment on study (day 1)
Prior complete resection of all NSCLC (patients could have undergone prior resection as long as it is not complete and the patient meets criteria and staging and tumor volume for registration)
Severe, active co-morbidity, defined as follows
Uncontrolled neuropathy grade 2 regardless of cause
Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
Transmural myocardial infarction within the last 6 months
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease
HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol unless patient is known to be HIV positive and they do not had a CD4 count result within 30 days prior to registration
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment, not inclusive of patients who are HIV positive and who meet criterion above
Note: Patients who require continuous or intermittent steroid therapy for non-
autoimmune conditions, e.g. asthma, osteoarthritis or intravenous contrast
allergy, are eligible permitted those patients who receive continuous steroids
are limited to a dose of 10 mg/day of prednisone (or equivalent). Higher doses
are permitted for intermittent therapy, e.g. for contrast allergy, but will
need to be approved by BrUOG prior to registration
Has a known history of active tuberculosis
Hypersensitivity to Durvalumab or any of its excipients
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Has known history of clinically significant pneumonitis
Has an active infection requiring intravenous systemic therapy at the time of registration
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating physician
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial as per the treating physician
Is pregnant or breastfeeding
Has received prior therapy with an anti-CTLA-4, -PD-1, -PD-L1, or -PD-L2 agent
Has a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA)
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note