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

Protocol-ID: 2642 V1.0 (Complete), 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).

Cycle diagram

Hydration: Balanced Crystalloid Solution

Substance	1	2	3	4	5	6	7
	Week 1 / d
Balanced Crystalloid Solution 500 ml i.v.

Prevention of Acute Systemic Reactions: Paclitaxel

Substance	1	2	3	4	5	6	7
	Week 1 / d
Dimetinden 4 mg i.v.
Cimetidine 300 mg i.v.

Antiemesis: Emetogenicity high (CRBP), FOSAP, GRAN i.v., DEXA i.v.

Substance	1	2	3	4	5	6	7
	Week 1 / d
Fosaprepitant 150 mg i.v.
Dexamethasone 12 mg i.v.
Granisetron 1 mg i.v.

Antineoplastic therapy: NIVO360/CRBP5/PACL175

Substance	1	2	3	4	5	6	7
	Week 1 / d
Nivolumab 360 mg i.v.
Carboplatin 5 AUC i.v.
Paclitaxel 175 mg/m² KOF i.v.

Cycles

Cycle length 21 days, recommended cycles: 4

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.

Pharmacokinetics

Cimetidine and Fosaprepitant are CYP3A4 inhibitors, use caution with concomitant use of CYP3A4 substrates

Original indication

Non-Small Cell Lung Cancer, Stage IIA/IIIB, ECOG 0-1, ALK and EGFR negative.

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

Status

Valid since 2024-06-13, Version 1.0, last updated 2026-08-11

Last modification: V1.0: Sequence according to primary literature, durations according to the respective summaries of product characteristics.

Important notice

The copyrighted protocols are treatment recommendations. The information contained in this compilation on cytostatic drugs, concomitant medication and other therapeutic procedures, as well as dosage and application information, is continuously reviewed with all due care by the authors and editors involved. Nevertheless, the publishers and authors do not assume any liability for the correctness - also with regard to possible printing errors.

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