Difference between revisions of "Non-small cell lung cancer, HER2-mutated"

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[[#top|Back to Top]]
 
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Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens.
 
Note: these are regimens tested in biomarker-specific populations, please see the '''[[Non-small cell lung cancer|main NSCLC page]]''' for other regimens.
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
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{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
 
=Guidelines=
 
=Guidelines=
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'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
 
==[https://www.asco.org/ ASCO]==
 
==[https://www.asco.org/ ASCO]==
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*'''2022:''' Singh et al. [https://doi.org/10.1200/jco.22.00824 Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline]
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*'''2022:''' Singh et al. [https://doi.org/10.1200/jco.22.00824 Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline] [https://www.ncbi.nlm.nih.gov/pubmed/35816666 PubMed]
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==[https://www.esmo.org/ ESMO]==
 
==[https://www.esmo.org/ ESMO]==
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*'''2023:''' Hendriks et al. [https://doi.org/10.1016/j.annonc.2022.12.009 Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up]
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*'''2023:''' Hendriks et al. [https://doi.org/10.1016/j.annonc.2022.12.009 Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up] [https://www.ncbi.nlm.nih.gov/pubmed/36872130 PubMed]
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==NCCN==
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*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1450 NCCN Guidelines - Non-Small Cell Lung Cancer].''
  
 
=Metastatic disease, all lines of therapy=
 
=Metastatic disease, all lines of therapy=
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==Carboplatin, Pemetrexed, Pembrolizumab {{#subobject:a3c8c5|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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===Regimen {{#subobject:04328c|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
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!style="width: 20%"|Dates of enrollment
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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|-
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|[https://www.clinicaltrials.gov/study/NCT05048797 Awaiting publication (DESTINY-Lung04)]
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|2021-ongoing
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|style="background-color:#1a9851"|Phase 3 (C)
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|[[#Trastuzumab_deruxtecan_monotherapy|T-DXd]]
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|style="background-color:#d3d3d3"|TBD if different primary endpoint of PFS
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|-
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|}
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<div class="toccolours" style="background-color:#b3e2cd">
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====Chemotherapy====
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*[[Carboplatin (Paraplatin)]]
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*[[Pemetrexed (Alimta)]]
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====Immunotherapy====
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*[[Pembrolizumab (Keytruda)]]
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</div></div>
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===References===
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#'''DESTINY-Lung04:''' [https://clinicaltrials.gov/study/NCT05048797 NCT05048797]
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==Cisplatin, Pemetrexed, Pembrolizumab {{#subobject:a3csc5|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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===Regimen {{#subobject:04sp8c|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 +
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 +
|-
 +
|[https://www.clinicaltrials.gov/study/NCT05048797 Awaiting publication (DESTINY-Lung04)]
 +
|2021-ongoing
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Trastuzumab_deruxtecan_monotherapy|T-DXd]]
 +
|style="background-color:#d3d3d3"|TBD if different primary endpoint of PFS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
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====Chemotherapy====
 +
*[[Cisplatin (Platinol)]]
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*[[Pemetrexed (Alimta)]]
 +
====Immunotherapy====
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*[[Pembrolizumab (Keytruda)]]
 +
</div></div>
 +
===References===
 +
#'''DESTINY-Lung04:''' [https://clinicaltrials.gov/study/NCT05048797 NCT05048797]
 
==Trastuzumab deruxtecan monotherapy {{#subobject:7hg71v|Regimen=1}}==
 
==Trastuzumab deruxtecan monotherapy {{#subobject:7hg71v|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
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|[https://www.clinicaltrials.gov/ct2/show/NCT04644237 Awaiting publication (DESTINY-Lung02)]
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|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ Goto et al. 2023 (DESTINY-Lung02)]
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|2021-ongoing
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|2021-03 to 2022-03
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|-
 
|-
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|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
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|[https://www.clinicaltrials.gov/ct2/show/NCT04644237 Awaiting publication (DESTINY-Lung02)]
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|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ Goto et al. 2023 (DESTINY-Lung02)]
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|2021-ongoing
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|2021-03 to 2022-03
 
|style="background-color:#91cf61"|Phase 2
 
|style="background-color:#91cf61"|Phase 2
 
|-
 
|-
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</div></div>
 
</div></div>
 
===References===
 
===References===
−
#'''DESTINY-Lung01:''' Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. [https://doi.org/10.1056/nejmoa2112431 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9066448/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34534430/ PubMed] NCT03505710
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#'''DESTINY-Lung01:''' Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. [https://doi.org/10.1056/nejmoa2112431 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9066448/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34534430/ PubMed] [https://clinicaltrials.gov/study/NCT03505710 NCT03505710]
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#'''DESTINY-Lung02:''' NCT04644237
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#'''DESTINY-Lung02:''' Goto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, Ahn MJ, Smit EF, de Langen AJ, Pérol M, Pons-Tostivint E, Novello S, Hayashi H, Shimizu J, Kim DW, Kuo CH, Yang JC, Pereira K, Cheng FC, Taguchi A, Cheng Y, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. J Clin Oncol. 2023 Nov 1;41(31):4852-4863. Epub 2023 Sep 11. Erratum in: J Clin Oncol. 2023 Dec 19;:JCO2302574. [https://doi.org/10.1200/jco.23.01361 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc10617843/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/37694347/ PubMed] [https://clinicaltrials.gov/study/NCT04644237 NCT04644237]
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Non-small cell lung cancer regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Non-small cell lung cancers]]
 
[[Category:Non-small cell lung cancers]]

Revision as of 11:29, 13 May 2024

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Page editor Section editor
Singhi Eric.jpeg
 Eric K. Singhi, MD
MD Anderson Cancer Center
Houston, TX, USA
LinkedIn
Amit Kulkarni.jpg
 Amit Kulkarni, MBBS
University of Minnesota
Minneapolis, MN, USA
LinkedIn

Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.

3 regimens on this page
4 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

ASCO

ESMO

NCCN

Metastatic disease, all lines of therapy

Carboplatin, Pemetrexed, Pembrolizumab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (DESTINY-Lung04) 2021-ongoing Phase 3 (C) T-DXd TBD if different primary endpoint of PFS

Chemotherapy

Immunotherapy

References

  1. DESTINY-Lung04: NCT05048797

Cisplatin, Pemetrexed, Pembrolizumab

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (DESTINY-Lung04) 2021-ongoing Phase 3 (C) T-DXd TBD if different primary endpoint of PFS

Chemotherapy

Immunotherapy

References

  1. DESTINY-Lung04: NCT05048797

Trastuzumab deruxtecan monotherapy

Regimen variant #1, 5.4 mg/kg

FDA-recommended dose
Study Dates of enrollment Evidence
Goto et al. 2023 (DESTINY-Lung02) 2021-03 to 2022-03 Phase 2 (RT)

Biomarker eligibility criteria

  • HER2 mutations

Antibody-drug conjugate therapy

21-day cycles


Regimen variant #2, 6.4 mg/kg

Study Dates of enrollment Evidence
Li et al. 2021 (DESTINY-Lung01) 2018-2020 Phase 2
Goto et al. 2023 (DESTINY-Lung02) 2021-03 to 2022-03 Phase 2

Biomarker eligibility criteria

  • HER2 mutations

Antibody-drug conjugate therapy

21-day cycles

References

  1. DESTINY-Lung01: Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazières J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Pérol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Jänne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. Epub 2021 Sep 18. link to original article contains dosing details in manuscript link to PMC article PubMed NCT03505710
  2. DESTINY-Lung02: Goto K, Goto Y, Kubo T, Ninomiya K, Kim SW, Planchard D, Ahn MJ, Smit EF, de Langen AJ, Pérol M, Pons-Tostivint E, Novello S, Hayashi H, Shimizu J, Kim DW, Kuo CH, Yang JC, Pereira K, Cheng FC, Taguchi A, Cheng Y, Feng W, Tsuchihashi Z, Jänne PA. Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non-Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. J Clin Oncol. 2023 Nov 1;41(31):4852-4863. Epub 2023 Sep 11. Erratum in: J Clin Oncol. 2023 Dec 19;:JCO2302574. link to original article link to PMC article contains dosing details in manuscript PubMed NCT04644237
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