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m (Replaced content with "==Carboplatin & Paclitaxel (CP) {{#subobject:3a6h8q|Regimen=1}}== CP: '''<u>C</u>'''arboplatin & '''<u>P</u>'''aclitaxel ===Regimen {{#subobject:1yg1q7|Variant=1}}=== {|...")
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m (Replaced content with "==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab <div class="tocc...")
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==Carboplatin & Paclitaxel (CP) {{#subobject:3a6h8q|Regimen=1}}==
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==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
 
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CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
CP: '''<u>C</u>'''arboplatin & '''<u>P</u>'''aclitaxel
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<div class="toccolours" style="background-color:#eeeeee">
===Regimen {{#subobject:1yg1q7|Variant=1}}===
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===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
!style="width: 20%"|Years of enrollment
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!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
|[https://doi.org/10.1056/nejmoa2202170 Forde et al. 2022 (CheckMate 816)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
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{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
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|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
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|-
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|Click to learn more!
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|-
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|}
 
|2017-2019
 
|2017-2019
| style="background-color:#1a9851" |Phase 3 (C)
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
|1. [[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_Nivolumab|CP & Nivolumab]]<br>2. [[#Cisplatin_.26_Vinorelbine_.28CVb.29_.26_Nivolumab|CVb & Nivolumab]]<br>3. [[#Cisplatin_.26_Docetaxel_.28DC.29_.26_Nivolumab|DC & Nivolumab]]
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|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
| style="background-color:#d73027" |Inferior EFS
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| style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75)
 
|-
 
|-
 
|}
 
|}
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====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*CheckMate 816: No sensitizing EGFR or ALK mutations
 
*CheckMate 816: No sensitizing EGFR or ALK mutations
</div>
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</div></div>
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
 
 
*[[Carboplatin (Paraplatin)]] AUC 5 or 6 IV once on day 1
 
*[[Paclitaxel (Taxol)]] 175 or 200 mg/m<sup>2</sup> IV once on day 1
 
 
 
'''21-day cycle for 3 cycles'''
 
</div>
 
<div class="toccolours" style="background-color:#cbd5e8">
 
====Subsequent treatment====
 
 
 
*[[Surgery#Surgical_resection|Complete resection]]
 
</div>
 
===References===
 
#'''CheckMate 816:''' Forde PM, Spicer J, Lu S, Provencio M, Mitsudomi T, Awad MM, Felip E, Broderick SR, Brahmer JR, Swanson SJ, Kerr K, Wang C, Ciuleanu TE, Saylors GB, Tanaka F, Ito H, Chen KN, Liberman M, Vokes EE, Taube JM, Dorange C, Cai J, Fiore J, Jarkowski A, Balli D, Sausen M, Pandya D, Calvet CY, Girard N; CheckMate 816 Investigators. Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer. N Engl J Med. 2022 May 26;386(21):1973-1985. Epub 2022 Apr 11. [https://doi.org/10.1056/nejmoa2202170 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35403841/ PubMed] NCT02998528
 

Latest revision as of 12:58, 18 July 2024

Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC
Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations