BC Cancer Protocol Summary for Treatment of Advanced Non-
Small Cell Lung Cancer Using Nivolumab
Protocol Code LUAVNIV
Tumour Group Lung
Contact Physician Dr. Christopher Lee
ELIGIBILITY:
Patients must have:
Advanced non-small cell lung cancer, irrespective of histology, and
Disease progression on or after prior platinum-based chemotherapy requiring
second- or subsequent-line therapy
Note:
In the advanced setting, patients are eligible to receive nivolumab, atezolizumab or
pembrolizumab, but not sequential use of these agents
CAP approval is not required to switch between LUAVNIV and LUAVNIV4.
Patients should have:
Good performance status (ECOG 0-2)
Adequate hepatic and renal function
Access to a treatment centre with expertise to manage immune-mediated adverse
reactions of nivolumab
EXCLUSIONS:
Patients must not have:
Relapsed on or within 6 months of completing adjuvant durvalumab or atezolizumab,
or
Prior use of first-line nivolumab and ipilimumab or pembrolizumab
CAUTION:
Active, known or suspected autoimmune disease
Patients with long term immunosuppressive therapy or systemic corticosteroids
(requiring more than 10 mg predniSONE/day or equivalent)
BC Cancer Protocol Summary LUAVNIV Page 1 of 3
Activate1 Mar 2017 Revised: 1 Aug 2023 (Eligibility and exclusions 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 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
C-reactive protein and albumin (optional, and results do not have to be available to
proceed with first treatment)
Before each treatment: CBC & differential, platelets, creatinine, alkaline phosphatase,
ALT, total bilirubin, LDH, sodium, potassium, TSH
If clinically indicated: chest x-ray, 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, ECG
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 nivolumab: 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
3 mg/kg IV in 50 to 100 mL NS over 30 minutes
nivolumab
(maximum 240 mg) Using a 0.2 micron in-line filter
Repeat every 2 weeks until disease progression or unacceptable toxicity
If pseudo progression on imaging is suspected, may continue treatment for another
6 weeks. Discontinue treatment if confirmatory progression on subsequent scan (6-
10 weeks)
DOSE MODIFICATIONS:
No specific dose modifications. Toxicity managed by treatment delay and other
measures. (see SCIMMUNE protocol for management of immune-mediated adverse
reactions to checkpoint inhibitors immunotherapy,
http://www.bccancer.bc.ca/chemotherapy-protocols-
site/Documents/Supportive%20Care/SCIMMUNE_Protocol.pdf).
BC Cancer Protocol Summary LUAVNIV Page 2 of 3
Activate1 Mar 2017 Revised: 1 Aug 2023 (Eligibility and exclusions 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 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 protocol for
management of immune-mediated adverse reactions to checkpoint inhibitors
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. Discontinue nivolumab with severe reactions (Grade 3 or 4). Patients with
mild or moderate infusion reactions may receive nivolumab with close monitoring
and use of premedication.
Contact Dr. Christopher Lee or tumour group delegate at (604) 930-2098 or 1-
800-523-2885 with any problems or questions regarding this treatment program.
REFERENCES:
1. Bristol-Myers Squibb: OPDIVO (nivolumab) product monograph. Montreal, Quebec: 24 September 2015.
2. Brahmer J, Reckcamp KL, Baas P, et al. Nivolumab vs docetaxel in advanced squamous cell non-small cell lung
cancer. N Engl J Med 2015;373(2):123-5.
3. Borghaei H, Paz-Ares L, Horn L, et al. Nivolumab vs docetaxel in advanced nonsquamous non-small cell lung
cancer. N Engl J Med 2015;373(17):1627-39.
4. Gettinger SN, Horn L, Gandhi L, et al. Overall survival and long-term safety of nivolumab (anti-programmed
death 1 antibody, BMS-936558, ONO-4538) in patients with previously treated advanced non-small cell lung
cancer. J Clin Oncol 2015;33(18):2004-12.
5. Weber JS, et al. Management of adverse events following treatment with anti-programmed death-1 agents.
Oncologist 2016;21:1-11.
6. Waterhouse D, Horn L, Reynolds C, et al. Safety profile of nivolumab administered as 30-min infusion: analysis
of data from CheckMate 153. Cancer Chemother Pharmacol 2018;81:679-86.
BC Cancer Protocol Summary LUAVNIV Page 3 of 3
Activate1 Mar 2017 Revised: 1 Aug 2023 (Eligibility and exclusions 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 www.bccancer.bc.ca/terms-of-use.
