BC Cancer Protocol Summary for Treatment of Locally Advanced
Non-Small Cell Lung Cancer Using Durvalumab
Protocol Code LULADUR
Tumour Group Lung
Contact Physician Dr. Angela Chan
ELIGIBILITY:
Patients must have:
Stage III unresectable NSCLC,
No disease progression following prior treatment with at least 2 cycles of platinum-
based chemotherapy given concurrently with radiation (e.g., LULAPERT,
LULAPE2RT, LULACATRT)
Patients should have:
ECOG 0-1,
Adequate hepatic and renal function,
Access to a treatment centre with expertise to manage immune-mediated adverse
reactions of durvalumab
Notes:
CAP approval is not required to switch between LULADUR and LULADUR4
Patients may have subsequent checkpoint inhibitors provided the last dose of
durvalumab was > 6 months. They are not eligible if they progressed on durvalumab
Patients whose cancer is unresectable after prior neoadjuvant nivolumab (i.e., after
prior treatment with LUAJNIVPC or LUAJNIVPP), and who have received
chemotherapy concurrently with radiation, are eligible for LULADUR/LULADUR4
EXCLUSIONS:
Patients must not have:
ECOG performance status ≥ 2
CAUTIONS:
Active or previous autoimmune disease (within the past 2 years)
Unresolved toxic effects of Grade ≥ 2 from prior treatment
Grade ≥ 2 pneumonitis from prior chemoradiotherapy
Patients with long term immunosuppressive therapy or systemic corticosteroids
(requiring more than 10 mg predniSONE/day or equivalent)
BC Cancer Protocol Summary LULADUR Page 1 of 3
Activated: 1 Feb 2020 Revised: 1 Feb 2024 (Eligibility updated)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at http://www.bccancer.bc.ca/terms-of-use
TESTS:
Baseline: CBC & differential, platelets, creatinine, alkaline phosphatase, ALT, total
bilirubin, LDH, sodium, potassium, TSH, morning serum cortisol, chest x-ray
Before each treatment: CBC & differential, platelets, creatinine, alkaline phosphatase,
ALT, total bilirubin, LDH, sodium, potassium, TSH
If clinically indicated: chest x-ray, ECG, morning serum cortisol, lipase, glucose,
serum or urine hCG (required for women of child bearing potential if pregnancy
suspected), free T3 and free T4, serum ACTH levels, testosterone, estradiol, FSH, LH
Weekly telephone nursing assessment for signs and symptoms of side effects while
on treatment (optional)
PREMEDICATIONS:
Antiemetics are not usually required
Antiemetic protocol for low emetogenicity (see SCNAUSEA)
If prior infusion reactions to durvalumab: diphenhydrAMINE 50 mg PO,
acetaminophen 325 to 975 mg PO, and hydrocortisone 25 mg IV 30 minutes prior to
treatment
TREATMENT:
Drug Dose BC Cancer Administration Guideline
10 mg/kg IV in 100 mL NS over 60 minutes
durvalumab
(maximum 750 mg) Using a 0.2 micron in-line filter
Repeat every 2 weeks for 1 year of treatment (including doses given as
LULADUR4), unless disease progression or unacceptable toxicity
DOSE MODIFICATIONS:
No specific dose modifications. Toxicity managed by treatment delay and other
measures (see SCIMMUNE for management of immune-mediated adverse reactions to
checkpoint inhibitor immunotherapy: http://www.bccancer.bc.ca/chemotherapy-
protocols-site/Documents/Supportive%20Care/SCIMMUNE_Protocol.pdf).
BC Cancer Protocol Summary LULADUR Page 2 of 3
Activated: 1 Feb 2020 Revised: 1 Feb 2024 (Eligibility updated)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at http://www.bccancer.bc.ca/terms-of-use
PRECAUTIONS:
1. Serious immune-mediated reactions: can be severe to fatal and usually occur
during the treatment course, but may develop months after discontinuation of
therapy. They may include enterocolitis, intestinal perforation or hemorrhage,
hepatitis, dermatitis, neuropathy, endocrinopathy, pneumonitis, as well as toxicities
in other organ systems. Early diagnosis and appropriate management are essential
to minimize life-threatening complications (see SCIMMUNE for management of
immune-mediated adverse reactions to checkpoint inhibitor immunotherapy:
http://www.bccancer.bc.ca/chemotherapy-protocols-
site/Documents/Supportive%20Care/SCIMMUNE_Protocol.pdf).
2. Infusion-related reactions: isolated cases of severe infusion reactions have been
reported. For mild or moderate infusion reactions, decrease the infusion rate to 50%
or temporarily interrupt infusion until the reaction has resolved. Consider
premedication for subsequent infusions. Permanently discontinue durvalumab for
severe reactions.
3. Infections: severe infections such as sepsis, necrotizing fasciitis, and osteomyelitis
have been reported. Treat suspected or confirmed infections as indicated. Withhold
durvalumab for severe infections.
Contact Dr. Angela Chan or tumour group delegate at (604) 930-2098 or 1-800-
523-2885 with any problems or questions regarding this treatment program.
REFERENCES:
1. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after Chemoradiotherapy in Stage III Non-Small
Cell Lung Cancer. N Engl J Med 2017; 377:1919-29.
2. Antonia SJ, Villegas A, Daniel D, et al. Overall Survival with Durvalumab After Chemoradiotherapy in
Stage III NSCLC. N Engl J Med 2018; 379;24:2342-50.
3. AstraZeneca Canada Inc. IMFINZI® product monograph. Mississauga, Ontario; 23 August 2019.
BC Cancer Protocol Summary LULADUR Page 3 of 3
Activated: 1 Feb 2020 Revised: 1 Feb 2024 (Eligibility updated)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician seeking to
apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of these documents is at
your own risk and is subject to BC Cancer's terms of use available at http://www.bccancer.bc.ca/terms-of-use
