Difference between revisions of "Non-small cell lung cancer, KRAS-mutated"
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# '''GSK 114653:''' Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. [https://doi.org/10.1093/annonc/mdv072 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25722381 PubMed] NCT01362296 | # '''GSK 114653:''' Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. [https://doi.org/10.1093/annonc/mdv072 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4855243/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/25722381 PubMed] NCT01362296 | ||
# '''SELECT-1:''' Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. [http://jamanetwork.com/journals/jama/article-abstract/2625317 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5815037/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28492898 PubMed] NCT01933932 | # '''SELECT-1:''' Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. [http://jamanetwork.com/journals/jama/article-abstract/2625317 link to original article] '''contains verified protocol''' [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc5815037/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28492898 PubMed] NCT01933932 | ||
+ | |||
+ | ==Sotorasib monotherapy {{#subobject:fgac16|Regimen=1}}== | ||
+ | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
+ | |- | ||
+ | |[[#top|back to top]] | ||
+ | |} | ||
+ | ===Regimen {{#subobject:15yvb6|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="color:white; background-color:#404040" | ||
+ | |<small>'''FDA-recommended dose'''</small> | ||
+ | |- | ||
+ | |} | ||
+ | {| class="wikitable sortable" style="width: 75%; text-align:center;" | ||
+ | !style="width: 33%"|Study | ||
+ | !style="width: 33%"|Years of enrollment | ||
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | |- | ||
+ | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7571518/ Hong et al. 2020 (CodeBreaK100)] | ||
+ | |2018-ongoing | ||
+ | | style="background-color:#91cf61" |Phase 1/2 (RT) | ||
+ | |- | ||
+ | |} | ||
+ | ''Note: this is the dose used in the expansion cohort.'' | ||
+ | ====Targeted therapy==== | ||
+ | *[[Sotorasib (Lumakras)]] 960 mg PO once per day | ||
+ | |||
+ | '''Continued indefinitely''' | ||
+ | ===References=== | ||
+ | #'''CodeBreaK100:''' Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. Epub 2020 Sep 20. [https://doi.org/10.1056/nejmoa1917239 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc7571518/ link to PMC article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/32955176 PubMed] NCT03600883 | ||
[[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 15:18, 1 June 2021
Page editor | Section editor | ||
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Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN ![]() |
Travis Osterman, DO, MS, FAMIA Vanderbilt University Nashville, TN ![]() |
Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
3 regimens on this page
3 variants on this page
|
Advanced or metastatic disease, subsequent lines of therapy
Docetaxel monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Blumenschein et al. 2015 (GSK 114653) | 2011-2012 | Randomized Phase II (C) | Trametinib | Did not meet primary endpoint of PFS |
Jänne et al. 2017 (SELECT-1) | 2013-2016 | Phase III (C) | Docetaxel & Selumetinib | Did not meet primary endpoint of PFS |
Chemotherapy
- Docetaxel (Taxotere) 75 mg/m2 IV over 60 minutes once on day 1
Supportive medications
- Per JMEI: Dexamethasone (Decadron) 8 mg PO twice per day on days -1 to 2 (3 days)
- Per Chem et al. 2006: Dexamethasone (Decadron) as follows:
- 8 mg PO once per day on days 1, 8, 15; 12 hours prior to Docetaxel (Taxotere)
- 10 mg IV once per day on days 1, 8, 15; 30 minutes prior to Docetaxel (Taxotere)
- 8 mg PO once per day on days 1, 8, 15; 12 hours after Docetaxel (Taxotere)
21-day cycles
References
- GSK 114653: Blumenschein GR Jr, Smit EF, Planchard D, Kim DW, Cadranel J, De Pas T, Dunphy F, Udud K, Ahn MJ, Hanna NH, Kim JH, Mazieres J, Kim SW, Baas P, Rappold E, Redhu S, Puski A, Wu FS, Jänne PA. A randomized phase II study of the MEK1/MEK2 inhibitor trametinib (GSK1120212) compared with docetaxel in KRAS-mutant advanced non-small-cell lung cancer (NSCLC). Ann Oncol. 2015 May;26(5):894-901. Epub 2015 Feb 26. link to original article link to PMC article contains verified protocol PubMed NCT01362296
- SELECT-1: Jänne PA, van den Heuvel MM, Barlesi F, Cobo M, Mazieres J, Crinò L, Orlov S, Blackhall F, Wolf J, Garrido P, Poltoratskiy A, Mariani G, Ghiorghiu D, Kilgour E, Smith P, Kohlmann A, Carlile DJ, Lawrence D, Bowen K, Vansteenkiste J. Selumetinib plus docetaxel compared with docetaxel alone and progression-free survival in patients with KRAS-mutant advanced non-small cell lung cancer: The SELECT-1 randomized clinical trial. JAMA. 2017 May 9;317(18):1844-1853. link to original article contains verified protocol link to PMC article PubMed NCT01933932
Sotorasib monotherapy
back to top |
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence |
---|---|---|
Hong et al. 2020 (CodeBreaK100) | 2018-ongoing | Phase 1/2 (RT) |
Note: this is the dose used in the expansion cohort.
Targeted therapy
- Sotorasib (Lumakras) 960 mg PO once per day
Continued indefinitely
References
- CodeBreaK100: Hong DS, Fakih MG, Strickler JH, Desai J, Durm GA, Shapiro GI, Falchook GS, Price TJ, Sacher A, Denlinger CS, Bang YJ, Dy GK, Krauss JC, Kuboki Y, Kuo JC, Coveler AL, Park K, Kim TW, Barlesi F, Munster PN, Ramalingam SS, Burns TF, Meric-Bernstam F, Henary H, Ngang J, Ngarmchamnanrith G, Kim J, Houk BE, Canon J, Lipford JR, Friberg G, Lito P, Govindan R, Li BT. KRASG12C Inhibition with Sotorasib in Advanced Solid Tumors. N Engl J Med. 2020 Sep 24;383(13):1207-1217. Epub 2020 Sep 20. link to original article link to PMC article contains verified protocol PubMed NCT03600883