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

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m (Text replacement - "'''contains verified protocol'''" to "'''contains dosing details in manuscript'''")
m
 
(31 intermediate revisions by 3 users not shown)
Line 3: Line 3:
 
[[#top|Back to Top]]
 
[[#top|Back to Top]]
 
</div>
 
</div>
−
{{#lst:Section editor transclusions|nsclc}}
+
{{#lst:Editorial board transclusions|nsclc}}
 
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.
 +
<br>There are several related dedicated pages:
 +
*'''Histology-specific:'''
 +
**'''[[Non-small_cell_lung_cancer,_nonsquamous|NSCLC, Nonsquamous]]'''
 +
**'''[[Non-small_cell_lung_cancer,_squamous|NSCLC, Squamous]]'''
 +
*'''Site-specific:'''
 +
**'''[[Non-small cell lung cancer, CNS metastases|NSCLC, CNS metastases]]'''
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
{| class="wikitable" style="float:right; margin-right: 5px;"
 
|-
 
|-
Line 11: Line 17:
 
|}
 
|}
 
{{TOC limit|limit=3}}
 
{{TOC limit|limit=3}}
−
=Metastatic disease=
+
=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.'''
 +
==[https://www.asco.org/ ASCO]==
 +
*'''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://pubmed.ncbi.nlm.nih.gov/35816666 PubMed]
 +
==[https://www.esmo.org/ ESMO]==
 +
*'''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://pubmed.ncbi.nlm.nih.gov/36872130 PubMed]
 +
==NCCN==
 +
*''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=
 
==Capmatinib monotherapy {{#subobject:791280|Regimen=1}}==
 
==Capmatinib monotherapy {{#subobject:791280|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:f3e479|Variant=1}}===
 
===Regimen {{#subobject:f3e479|Variant=1}}===
 
{| class="wikitable" style="color:white; background-color:#404040"
 
{| class="wikitable" style="color:white; background-color:#404040"
Line 22: Line 36:
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://doi.org/10.1056/nejmoa2002787 Wolf et al. 2020 (GEOMETRY mono-1)]
 
|[https://doi.org/10.1056/nejmoa2002787 Wolf et al. 2020 (GEOMETRY mono-1)]
−
|NR
+
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-233-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
 +
|-
 +
|} -->
 +
|2015 to not reported
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*MET exon 14 skipping alterations
 
*MET exon 14 skipping alterations
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
*[[Capmatinib (Tabrecta)]] 400 mg PO twice per day with or without food
+
*[[Capmatinib (Tabrecta)]] 400 mg PO twice per day on days 1 to 28, taken with or without food
−
 
+
'''28-day cycles'''
−
'''Continued indefinitely'''
+
</div></div>
−
 
 
 
===References===
 
===References===
−
<!-- # '''Abstract:''' Juergen Wolf, Takashi Seto, Ji-Youn Han, Noemi Reguart, Edward B. Garon, Harry J.M. Groen, Daniel Shao-Weng Tan, Toyoaki Hida, Maja J. De Jonge, Sergey V. Orlov, Egbert F. Smit, Pierre Jean Souquet, Johan F. Vansteenkiste, Monica Giovannini, Sylvie Le Mouhaer, Anna Robeva, Maeve Waldron-Lynch, Rebecca Suk Heist. Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study. [https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.9004 link to abstract] '''contains dosing details in manuscript''' [https://doi.org/10.1200/JCO.2019.37.15_suppl.9004 DOI] -->
+
<!-- # '''Abstract:''' Juergen Wolf, Takashi Seto, Ji-Youn Han, Noemi Reguart, Edward B. Garon, Harry J.M. Groen, Daniel Shao-Weng Tan, Toyoaki Hida, Maja J. De Jonge, Sergey V. Orlov, Egbert F. Smit, Pierre Jean Souquet, Johan F. Vansteenkiste, Monica Giovannini, Sylvie Le Mouhaer, Anna Robeva, Maeve Waldron-Lynch, Rebecca Suk Heist. Capmatinib (INC280) in METΔex14-mutated advanced non-small cell lung cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study. [https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.9004 link to abstract] '''dosing details in manuscript have been reviewed by our editors''' [https://doi.org/10.1200/JCO.2019.37.15_suppl.9004 DOI] -->
−
#'''GEOMETRY mono-1:''' Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. [https://doi.org/10.1056/nejmoa2002787 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/32877583 PubMed] NCT02414139
+
#'''GEOMETRY mono-1:''' Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. [https://doi.org/10.1056/nejmoa2002787 link to original article] '''dosing details in abstract have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/32877583/ PubMed] [https://clinicaltrials.gov/study/NCT02414139 NCT02414139]
  
 
==Tepotinib monotherapy {{#subobject:7it980|Regimen=1}}==
 
==Tepotinib monotherapy {{#subobject:7it980|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:f3eig9|Variant=1}}===
 
===Regimen {{#subobject:f3eig9|Variant=1}}===
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
{| class="wikitable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
+
!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
−
|[https://doi.org/10.1056/nejmoa2004407 Paik et al. 2020 (VISION<sub>NSCLC</sub>)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8422679/ Paik et al. 2020 (VISION<sub>NSCLC</sub>)]
 +
<!-- {| class="wikitable" style="margin:auto; color:white; background-color:#1B4F26"
 +
|'''[https://www.esmo.org/guidelines/esmo-mcbs/esmo-mcbs-scorecards/scorecard-253-1 <span style="color:white;">ESMO-MCBS (3)</span>]'''
 +
|-
 +
|} -->
 
|2016-2020
 
|2016-2020
 
|style="background-color:#91cf61"|Phase 2 (RT)
 
|style="background-color:#91cf61"|Phase 2 (RT)
Line 55: Line 79:
 
|}
 
|}
 
''Note: the FDA-recommended dose is 450 mg PO once per day; the dose here was the dose reported in VISION.''
 
''Note: the FDA-recommended dose is 450 mg PO once per day; the dose here was the dose reported in VISION.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*MET exon 14 skipping alterations
 
*MET exon 14 skipping alterations
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Tepotinib (Tepmetko)]] 500 mg PO once per day
 
*[[Tepotinib (Tepmetko)]] 500 mg PO once per day
−
 
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
 +
</div></div>
 +
===References===
 +
#'''VISION<sub>NSCLC</sub>:''' Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. Epub 2020 May 29. [https://doi.org/10.1056/nejmoa2004407 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8422679/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32469185/ PubMed] [https://clinicaltrials.gov/study/NCT02864992 NCT02864992]
  
 +
=Advanced or metastatic disease, subsequent lines of therapy=
 +
==Docetaxel monotherapy {{#subobject:fd1716|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:b495b6|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
! 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://clinicaltrials.gov/study/NCT04928846 Awaiting publication (M18-868)]
 +
|2022-ongoing
 +
| style="background-color:#1a9851" |Phase 3 (C)
 +
|[[#Telisotuzumab_vedotin_monotherapy_777|Telisotuzumab vedotin]]
 +
| style="background-color:#d3d3d3" |TBD if different co-primary outcomes of PFS/OS
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Docetaxel (Taxotere)]]
 +
'''21-day cycles'''
 +
</div></div>
 
===References===
 
===References===
−
#'''VISION<sub>NSCLC</sub>:''' Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. Epub 2020 May 29. [https://doi.org/10.1056/nejmoa2004407 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469185 PubMed] NCT02864992
+
#'''M18-868:''' [https://clinicaltrials.gov/study/NCT04928846 NCT04928846]
  
 
[[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]]

Latest revision as of 12:26, 18 July 2024

Back to Top

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.
There are several related dedicated pages:

3 regimens on this page
3 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

Capmatinib monotherapy

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence
Wolf et al. 2020 (GEOMETRY mono-1) 2015 to not reported Phase 2 (RT)

Biomarker eligibility criteria

  • MET exon 14 skipping alterations

Targeted therapy

28-day cycles

References

  1. GEOMETRY mono-1: Wolf J, Seto T, Han JY, Reguart N, Garon EB, Groen HJM, Tan DSW, Hida T, de Jonge M, Orlov SV, Smit EF, Souquet PJ, Vansteenkiste J, Hochmair M, Felip E, Nishio M, Thomas M, Ohashi K, Toyozawa R, Overbeck TR, de Marinis F, Kim TM, Laack E, Robeva A, Le Mouhaer S, Waldron-Lynch M, Sankaran B, Balbin OA, Cui X, Giovannini M, Akimov M, Heist RS; GEOMETRY mono-1 Investigators. Capmatinib in MET Exon 14-Mutated or MET-Amplified Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Sep 3;383(10):944-957. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT02414139

Tepotinib monotherapy

Regimen

Study Dates of enrollment Evidence
Paik et al. 2020 (VISIONNSCLC) 2016-2020 Phase 2 (RT)

Note: the FDA-recommended dose is 450 mg PO once per day; the dose here was the dose reported in VISION.

Biomarker eligibility criteria

  • MET exon 14 skipping alterations

Targeted therapy

Continued indefinitely

References

  1. VISIONNSCLC: Paik PK, Felip E, Veillon R, Sakai H, Cortot AB, Garassino MC, Mazieres J, Viteri S, Senellart H, Van Meerbeeck J, Raskin J, Reinmuth N, Conte P, Kowalski D, Cho BC, Patel JD, Horn L, Griesinger F, Han JY, Kim YC, Chang GC, Tsai CL, Yang JC, Chen YM, Smit EF, van der Wekken AJ, Kato T, Juraeva D, Stroh C, Bruns R, Straub J, Johne A, Scheele J, Heymach JV, Le X. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943. Epub 2020 May 29. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02864992

Advanced or metastatic disease, subsequent lines of therapy

Docetaxel monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Awaiting publication (M18-868) 2022-ongoing Phase 3 (C) Telisotuzumab vedotin TBD if different co-primary outcomes of PFS/OS

Chemotherapy

21-day cycles

References

  1. M18-868: NCT04928846
Retrieved from "https://hemonc.org/w/index.php?title=Non-small_cell_lung_cancer,_MET-mutated&oldid=89954"