Non-small cell lung cancer, HER2-mutated
Revision as of 19:19, 17 October 2023 by Warner-admin (talk | contribs) (Text replacement - "=Guidelines=" to "=Guidelines= '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any article published 5+ years ago to be for historical purposes, only.'''")
| Page editor | Section editor | ||
|---|---|---|---|
 |
Eric K. Singhi, MD MD Anderson Cancer Center Houston, TX, USA |
 |
Amit Kulkarni, MBBS University of Minnesota Minneapolis, MN, USA |
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 article published 5+ years ago to be for historical purposes, only.
ASCO
- 2022: Singh et al. Therapy for Stage IV Non-Small-Cell Lung Cancer With Driver Alterations: ASCO Living Guideline PubMed
ESMO
- 2023: Hendriks et al. Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up PubMed
NCCN
- NCCN does not have guidelines at this granular level; please see NCCN Guidelines - Non-Small Cell Lung Cancer.
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 |
References
- 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 |
References
- DESTINY-Lung04: NCT05048797
Trastuzumab deruxtecan monotherapy
Regimen variant #1, 5.4 mg/kg
| FDA-recommended dose |
| Study | Dates of enrollment | Evidence |
|---|---|---|
| Awaiting publication (DESTINY-Lung02) | 2021-ongoing | Phase 2 (RT) |
Biomarker eligibility criteria
- HER2 mutations
Antibody-drug conjugate therapy
- Trastuzumab deruxtecan (Enhertu) 5.4 mg/kg IV once on day 1
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 |
| Awaiting publication (DESTINY-Lung02) | 2021-ongoing | Phase 2 |
Biomarker eligibility criteria
- HER2 mutations
Antibody-drug conjugate therapy
- Trastuzumab deruxtecan (Enhertu) 6.4 mg/kg IV once on day 1
21-day cycles
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. link to original article contains dosing details in manuscript link to PMC article PubMed NCT03505710
- DESTINY-Lung02: NCT04644237