Nivolumab 360 / Carboplatin 5 / Paclitaxel 175, Non-Small Cell Lung Cancer, neoadjuvant, cycle 1-4

Protocol-ID: 2642 V1.0 (Standard), NIVO360/CRBP5/PACL175, NSCLC, neoadj., C1-4

Indication(s)

Lung Carcinoma, Non-Small Cell; ICD-10 C34.-

Protocol classification

Classification: current standard
Intensity: Standard dose
Therapy phase: neoadjuvant
Therapy intention: curative

Cycles

Cycle length 21 days, recommended cycles: 4

Protocol sequences

CM77T: NIVO360/CRBP5/PACL175, NSCLC, neoadj., C1-4 (PID2642) -|- NIVO480, adj., C5-18 (PID2646)

Risks

Emetogenicity (MASCC/ESMO): high (>90%)
Neutropenia: low (<10%)
Anemia Hb below 8g/dl: low (<5%)
Alopecia: CTC AE °1-2: 22%; °3-4: 1%
Constipation: CTC AE °1-2: 22%
Pneumonitis: CTC AE °1-2: 3%; °3-4: 2%
Colitis: CTC AE °1-2: 1%; °3-4: 1%
Rash: CTC AE °1-2: 4%; °3-4: 1%
Adrenal Insufficiency: CTC AE °1-2: 2%
Nephritis: CTC AE °1-2: 2%; °3-4: 1%
Hypothyroidism: CTC AE °1-2: 11%
Hyperthyroidism: CTC AE °1-2: 4%; °3-4: 1%
Hypophysitis: CTC AE °1-2: 1%

Therapy

Day	Substance	Dosage	Appl.	Inf. time	Procedure
HYD Hydration: Balanced Crystalloid Solution
Access: peripheral venous
Hydration before, during, or after antitumor therapy
1	Balanced Crystalloid Solution	500 ml	i.v.	60 min	60 min before Nivolumab (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
ASR Prevention of Acute Systemic Reactions: Paclitaxel
Access: peripheral venous
Dexamethasone, dimetindene, cimetidine, according to the paclitaxel technical info, patients must be pretreated with an H1 antihistamine, an H2 antihistamine, and a corticosteroid.
1	Dimetinden	4 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Nivolumab (d1)
1	Cimetidine	300 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Nivolumab (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
AE Antiemesis: Emetogenicity high (CRBP), FOSAP, GRAN i.v., DEXA i.v.
Access: peripheral venous
DGHO, ESMO, NCCN, ASCO; by 6/24, Carboplatin-containing combination therapies
1	Fosaprepitant	150 mg	NaCl 0.9% 150 ml	i.v.	20 min	30 min before Nivolumab (d1)
1	Dexamethasone	12 mg	NaCl 0.9% 50 ml	i.v.	5 min	30 min before Nivolumab (d1)
1	Granisetron	1 mg	NaCl 0.9% 50 ml	i.v.	5 min	15 min before Nivolumab (d1)

Day	Substance	Dosage	Solution	Appl.	Inf. time	Procedure
ANTX Antineoplastic therapy: NIVO360/CRBP5/PACL175
Access: peripheral venous
1	Nivolumab	360 mg	NaCl 0.9% 100 ml	i.v.	30 min	Sequence
1	Carboplatin	5 AUC	Dextrose 5% 250 ml	i.v.	30 min	Sequence
alternatively 6 AUC
1	Paclitaxel	175 mg/m² BSA	NaCl 0.9% 250 ml	i.v.	3 h	Sequence
alternatively 200 mg/m²

Substance links

Links to substances are found here.

Concomitant therapy supplements

For highly emetogenic chemotherapy, additional olanzapine is recommended in the acute (day 1) and delayed phases (days 2-4) at a dosing of 5-10 mg per day (NCCN, ESMO, ASCO, Onkopedia; as of 6/24). Dexamethasone for allergy prophylaxis is covered by dexamethasone for antiemesis.

Notes

Surgery is performed 3-4 weeks after completion of the 4th cycle. R0 resection is followed by adjuvant therapy with Nivolumab (see PID 2646).

Controls:

Blood count: on day 1 and subsequently weekly
Oxygen saturation In high-risk patients, lung function, CO2 diffusion capacity, CT thorax if necessary
ECG Risk of developing a conduction disorder with paclitaxel therapy, ECG monitoring every 3 cycles
Hepatitis (A,B,C) screening: anti-HAV IgM, HBs-Ag, anti-HBc, anti-HCV
CMV, EBV, HIV, tuberculosis screening
Day 1: Troponin T, CK, LDH
Day 1: Creatinine, glomerular filtration rate (GFR)
Day 1: Na⁺, K⁺, Ca²⁺, Mg²⁺
Day 1: GOT, GPT, GGT, Bilirubin, AP, Cholinesterase
Day 1: Lipase
Day 1: TSH, fT4, cortisol basal, blood glucose (HbA1c) optional and especially if clinically suspected: fT3, ACTH, DHEA-S, IGF1, prolactin, LH/FSH, estradiol (in women), every 6 weeks to 3 months after the end of immunotherapy and every 3 months thereafter.

Original author

Cascone T (2024)

Origin

University of Texas M.D. Anderson Cancer Center, Houston, CheckMate 77T

References

Cascone T, Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med 2024 May 16;390(19):1756-1769. doi: 10.1056/NEJMoa2311926. PMID: 38749033. [PMID] [DOI]

Recommendations

04/2024: National Comprehensive Cancer Network

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