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Safety Information for RYBREVANT – Nail Toxicity

Last Updated: 11/07/2024

SUMMARY

  • RYBREVANT (amivantamab-vmjw) is a low fucose, fully human immunoglobulin G1 (IgG1)-based bispecific antibody with immune cell-directing activity that targets epidermal growth factor receptor (EGFR) mutations and mesenchymal-epithelial transition (MET) mutations and amplifications in non-small cell lung cancer (NSCLC).1
  • LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor (TKI).2
  • MARIPOSA (NCT04487080) is an ongoing, phase 3, randomized study evaluating the efficacy and safety of RYBREVANT and lazertinib combination therapy (open-label, n=429) vs osimertinib (double-blind, n=429) vs lazertinib (double-blind, n=216) as first-line treatment in patients with EGFR-mutated (Exon 19 deletion [Exon19del] or Exon 21 L858R substitution) locally advanced or metastatic NSCLC.2-4
    • Among patients treated with RYBREVANT plus lazertinib, grade ≥3 paronychia was reported in 11% of patients. Paronychia led to treatment interruption, reduction, and discontinuation, respectively, in 22%, 19%, and 3% of patients receiving RYBREVANT plus lazertinib (Table: MARIPOSA: Incidence of Paronychia).
  • PAPILLON (NCT04538664) is an ongoing, phase 3, randomized, open-label study designed to compare the efficacy and safety of RYBREVANT plus chemotherapy (carboplatin and pemetrexed; n=153) vs chemotherapy alone (carboplatin and pemetrexed; n=155) in patients with untreated locally advanced or metastatic NSCLC and EGFR Exon 20 insertion (Exon20ins) mutations.5,6
    • Among patients treated with RYBREVANT plus chemotherapy, all-grade paronychia was reported in 85 (56%) patients and grade ≥3 paronychia was reported in 10 (7%) patients (Table: PAPILLON: Incidence of Paronychia).
  • MARIPOSA-2 (NCT04988295) is an ongoing, phase 3, randomized, open-label study designed to assess the efficacy and safety of RYBREVANT-lazertinib-chemotherapy (pemetrexed and carboplatin; n=263) and RYBREVANT-chemotherapy (pemetrexed and carboplatin; n=131) vs chemotherapy alone (pemetrexed and carboplatin; n=263) in patients with EGFR-mutated (Exon19del or Exon 21 L858R substitution) locally advanced or metastatic NSCLC on or after osimertinib monotherapy.7,8
    • Any-grade treatment-emergent paronychia was reported in 133 (51%) patients treated with RYBREVANT-lazertinib-chemotherapy and 48 (37%) patients treated with RYBREVANT-chemotherapy. Grade ≥3 treatment-emergent paronychia was reported in 11 (4%) patients treated with RYBREVANT-lazertinib-chemotherapy and 3 (2%) patients treated with RYBREVANT-chemotherapy (Table: MARIPOSA-2: Incidence of Treatment-Emergent Paronychia).
  • CHRYSALIS (NCT02609776) is an ongoing phase 1, open-label, multicenter, dose escalation and dose expansion study evaluating the safety, efficacy, and pharmacokinetics of RYBREVANT as monotherapy and in combination with other therapies in adult patients with advanced NSCLC harboring EGFR mutations who had disease progression during or after previous standard of care (SOC) treatment.9
    • Among 114 patients in the safety population, any-grade paronychia was reported in 51 (45%) patients and grade ≥3 paronychia was reported in 1 (1%) patient. Among all patients treated at the recommended phase 2 dose (RP2D, n=258), any-grade paronychia was reported in 104 (40%) patients and grade ≥3 paronychia was reported in 3 (1%) patients (Table: CHRYSALIS: Incidence of Paronychia in Patients Treated at the RP2D).
    • In a long-term analysis of 114 patients in the CHRYSALIS study cohort D with a median follow-up of 19.2 months, any-grade paronychia was reported in 66 (58%) patients and grade ≥3 paronychia was reported in 4 (4%) patients. Among all patients treated at the RP2D (n=474), any-grade paronychia was reported in 204 (43%) patients and grade ≥3 paronychia was reported in 9 (2%) patients (Table: CHRYSALIS Long-Term Analysis: Incidence of Paronychia in Patients Treated at the RP2D).10
    • In a post hoc analysis of 380 patients from the CHRYSALIS study who received RYBREVANT at the RP2D with a median follow-up of 7.6 months, treatment-related rash and/or paronychia was reported in 296 (78%) patients. Treatment-emergent paronychia was reported in 164 (43%) patients, and grade 3 paronychia was reported in 7 (2%) patients. No grade 4 events were reported (Table: CHRYSALIS Post Hoc Analysis: Incidence of Treatment-Emergent Paronychia in Patients Treated at the RP2D).11
  • For medical management of paronychia in the phase 3 studies, refer to Guidelines for the Medical Management of Paronychia in the PAPILLON, MARIPOSA-2, and MARIPOSA Studies.12-14
  • For medical management of paronychia in the CHRYSALIS study, refer to Guidelines for the Medical Management of Paronychia in the CHRYSALIS Study.15
  • For best practices for preventing and managing paronychia, refer to Best Practices for Prevention and Management of Paronychia Reported in the Literature.16
  • Please refer to RYBREVANT and LAZCLUZE product labeling for complete safety information, including dose modification guidelines for adverse reactions.
  • Please refer to product labeling for carboplatin and/or pemetrexed for complete prescribing information.

PRODUCT LABELING

CLINICAL DATA

MARIPOSA Study

Study Design/Methods

  • Phase 3, ongoing, randomized study designed to assess the efficacy and safety of RYBREVANT plus lazertinib (open-label, n=429) vs osimertinib (double-blind, n=429) vs lazertinib (double-blind, n=216) as first-line treatment in 1074 patients with EGFRmutated (Exon19del or L858R) locally advanced or metastatic NSCLC.2-4
    • RYBREVANT 1050 mg intravenous (IV; 1400 mg IV for body weight ≥80 kg) was administered every week for the first 4 weeks, with the initial dose as a split infusion on cycle 1 day 1 (C1D1) and D2, followed by every 2 weeks thereafter.
    • Lazertinib 240 mg was administered orally (PO) once daily.
    • Osimertinib 80 mg PO was administered once daily.

Results

  • The median duration of treatment was 18.5 months for RYBREVANT plus lazertinib and 18 months for osimertinib.2-4
  • The incidence of paronychia reported in the MARIPOSA study is shown in Table: MARIPOSA: Incidence of Paronychia.

MARIPOSA: Incidence of Paronychia4,17
AEs, n (%)
RYBREVANT + Lazertinib (n=421)
Osimertinib
(n=428)

All Grades
Grade ≥3
All Grades
Grade ≥3
Paronychia
288 (68)
46 (11)
121 (28)
2 (<1)
Treatment-related paronychia
285 (68)
44 (10)
115 (27)
2 (<1)
Paronychia leading to:
Interruption of any study drug in ≥3% of patients in any group
91 (22)
4 (1)
Reduction of any study drug in ≥1% of patients in any group
80 (19)
1 (<1)
Discontinuation of any study drug in ≥1% of patients in any group
14 (3)
0
Abbreviation: AE, adverse event.
aThe safety population included all randomized patients who received ≥1 dose of any study treatment.

Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.

PAPILLON Study

Study Design/Methods

  • Phase 3, ongoing, randomized, open-label study designed to compare the efficacy and safety of RYBREVANT plus chemotherapy (carboplatin and pemetrexed; n=153) vs chemotherapy alone (carboplatin and pemetrexed; n=155) in patients with untreated locally advanced or metastatic NSCLC and EGFR Exon20ins mutations.5,6
    • RYBREVANT 1400 mg IV (1750 mg IV for body weight ≥80 kg) was administered every week for the first 4 weeks, with the initial dose as a split infusion on C1D1 and D2, followed by RYBREVANT 1750 mg IV (2100 mg IV for body weight ≥80 kg) every 3 weeks starting at week 7 (C3D1) until disease progression.
    • Pemetrexed 500 mg/m2 IVwas administered every 3 weeks until disease progression.14
    • Carboplatin area under the curve (AUC) 5 IV was administered every 3 weeks for up to 4 cycles.

Results

  • The median duration of treatment was 9.7 months (range, 0.1-26.9) for RYBREVANT plus chemotherapy and 6.7 months (range, 0-25.3) for chemotherapy alone.5,6
  • The incidence of paronychia reported in the PAPILLON study is shown in Table: PAPILLON: Incidence of Paronychia.

PAPILLON: Incidence of Paronychia6
AEs, n (%)
RYBREVANT + Chemotherapy (n=151)
Chemotherapy
(n=155)

All Grades
Grade ≥3
All Grades
Grade ≥3
Paronychia
85 (56)
10 (7)
0
0
Abbreviation: AE, adverse event.
aThe safety population included all randomized patients who received ≥1 dose of any study treatment.

Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.

MARIPOSA-2 Study

Study Design/Methods

  • Phase 3, ongoing, randomized, open-label study designed to assess the efficacy and safety of RYBREVANT-lazertinib-chemotherapy (n=263) and RYBREVANT-chemotherapy (n=131) vs chemotherapy alone (n=263) in 657 patients with EGFR-mutated locally advanced or metastatic NSCLC on or after osimertinib monotherapy (as the most recent line of therapy).7,8
    • RYBREVANT 1400 mg IV (1750 mg IV for body weight ≥80 kg) was administered every week for the first 4 weeks, with the initial dose as a split infusion on C1D1 and D2, followed by 1750 mg IV (2100 mg IV for body weight ≥80 kg) every 3 weeks starting at week 7 (C3D1) until disease progression.
    • Lazertinib 240 mg PO was administered once daily.
    • Chemotherapy was administered every 3 weeks at the beginning of each cycle, with carboplatin at AUC 5 IV for the first 4 cycles, and pemetrexed at 500 mg/m2 IV until disease progression.
  • In the RYBREVANT-lazertinib-chemotherapy arm, patients randomized before November 7, 2022 received lazertinib on C1D1. Due to an increase in hematologic and gastrointestinal toxicities in the arm, the regimen was modified to start lazertinib after carboplatin completion.8
    • An open-label, randomized, extension cohort will evaluate the efficacy and safety of the modified RYBREVANT-lazertinib-chemotherapy regimen vs RYBREVANT-chemotherapy.

Results

  • At a median follow-up of 8.7 months, the median duration of treatment was 5.8 months for RYBREVANT-lazertinib-chemotherapy, 6.3 months for RYBREVANT-chemotherapy, and 3.7 months for chemotherapy alone.7,8
  • The incidence of paronychia reported in the MARIPOSA-2 study is shown in Table: MARIPOSA-2: Incidence of Treatment-Emergent Paronychia.

MARIPOSA-2: Incidence of Treatment-Emergent Paronychia8
TEAEs, n (%)
RYBREVANT-Lazertinib-Chemotherapy (n=263)
RYBREVANT-Chemotherapy (n=130)
Chemotherapy
(n=243)

All Grades
Grade ≥3
All Grades
Grade ≥3
All Grades
Grade ≥3
Paronychia
133 (51)
11 (4)
48 (37)
3 (2)
1 (0.4)
0
Abbreviation: TEAE, treatment-emergent adverse event.

Guidelines for prevention and management of paronychia throughout treatment were reported and are summarized below.

CHRYSALIS Study

The results of the CHRYSALIS study are also included in the RYBREVANT product labeling. The incidence of adverse reactions described below may vary from that in the RYBREVANT product labeling due to the evaluation of different patient populations for safety analyses, contributing to differences in reported percentages. The summary below describes safety results from patients with metastatic or unresectable NSCLC and EGFR Exon20ins mutations with disease progression during or after platinum-based chemotherapy who received RYBREVANT at the RP2D and all patients treated at the RP2D.

Study Design/Methods

  • Phase 1, ongoing, open-label, multicenter, dose escalation and dose expansion study evaluating the safety, efficacy, and pharmacokinetics of RYBREVANT as monotherapy and in combination with other therapies in adult patients with advanced NSCLC harboring EGFR mutations who had disease progression during or after previous SOC treatment.9
    • RYBREVANT monotherapy was administered at the RP2D: 1050 mg IV (1400 mg IV for body weight ≥80 kg) every week for C1, with the initial dose as a split infusion on C1D1 and D2, and every 2 weeks thereafter until disease progression or unacceptable toxicity.
    • A total of 114 patients with metastatic or unresectable NSCLC and EGFR Exon20ins mutations with disease progression during or after platinum-based chemotherapy were evaluated for safety, and 81 evaluable patients were assessed for efficacy.

Results


CHRYSALIS: Incidence of Paronychia in Patients Treated at the RP2D9
AEs, n (%)
Safety Population
(n=114)a

All Patients Treated at the RP2D (n=258)b
Total
Grade ≥3
Total
Grade ≥3
Paronychia
51 (45)
1 (1)
104 (40)
3 (1)
08 June 2020 safety data cutoff.
Abbreviations: AE, adverse event; EGFR, epidermal growth factor receptor; Exon20ins, exon 20 insertion; RP2D, recommended phase 2 dose.
aIncluded patients with EGFR Exon20ins mutation who progressed on platinum-based chemotherapy and were treated at the RP2D.
bIncluded all patients treated at the RP2D across the dose escalation phase and dose expansion phase.


CHRYSALIS Long-Term Analysis: Incidence of Paronychia in Patients Treated at the RP2D10
AEs, n (%)
Safety Population
(n=114)
All Patients Treated at the RP2D
(n=474)

Total
Grade ≥3
Total
Grade ≥3
Paronychia
66 (58)
4 (4)
204 (43)
9 (2)
12 September 2022 safety data cutoff.
Abbreviations: AE, adverse event; RP2D, recommended phase 2 dose.

Guidelines for management of paronychia throughout treatment were reported and are summarized below.

Additional Analysis

Singh-Kandah et al (2024)11 reported results from a post hoc analysis of the CHRYSALIS study on the incidence, severity, time to first onset, and management of rash and paronychia in patients treated with RYBREVANT at the RP2D (N=380).

  • As of the March 2021 data cutoff, the median treatment duration was 4.1 months, and the median follow-up was 7.6 months.
  • A total of 296/380 (78%) patients experienced treatment-related rash and/or paronychia.
  • Among all patients, treatment-emergent paronychia was reported in 164 (43%) patients. A majority of the 164 patients with paronychia also experienced rash (143/164; 87%).
  • Grade 3 paronychia was reported in 7 (2%) patients. No grade 4 events were reported. The incidence and time to first occurrence of paronychia are shown in Table: CHRYSALIS Post Hoc Analysis: Incidence of Treatment-Emergent Paronychia in Patients Treated at the RP2D.

CHRYSALIS Post Hoc Analysis: Incidence of Treatment-Emergent Paronychia in Patients Treated at the RP2D11
TEAEs, n (%)
Grade
Overall
Median Time to First Occurrence, Days
1
2
3
Paronychia
72 (19)
85 (22)
7 (2)
164 (43)
69
March 2021 data cutoff.
Abbreviations: RP2D, recommended phase 2 dose; TEAE, treatment-emergent adverse event.

  • Generally, rash and paronychia occurred throughout treatment, with rash occurring prior to paronychia (median onset of 15 days for rash and 69 days for paronychia).
  • During treatment, rash was reported by most patients within the first cycle, while onset of paronychia was spread across cycles. After 3 treatment cycles, grade ≥3 events of rash and paronychia were less frequent.
  • Dose reductions and treatment discontinuation occurred due to rash in 21/380 (6%) and 1/380 (0.3%) patients and due to paronychia in 10/380 (3%) and 2/380 (0.5%) patients, respectively.
  • Concomitant medications received by patients with rash or paronychia after therapy initiation to mitigate symptoms are summarized in Table: Most Common Concomitant Medications Used for Rash and Paronychia in CHRYSALIS.

Most Commona Concomitant Medications Used for Rash and Paronychia in CHRYSALIS11
Medication Type, n (%)
Rash
(n=288)

Paronychia
(n=164)

Any
255 (89)
125 (76)
Systemic antibiotics
187 (65)
58 (35)
Systemic corticosteroids
132 (46)
24 (15)
Topical corticosteroids
119 (41)
40 (24)
Systemic antihistamines
40 (14)
1 (1)
Topical antibiotics
38 (13)
57 (35)
Emollients and protectives
23 (8)
5 (3)
Topical antifungals
23 (8)
2 (1)
Antiacne preparations
17 (6)
4 (2)
Other dermatologic preparations
16 (6)
6 (4)
Ophthalmologic medications
13 (5)
23 (14)
Antiseptics and disinfectants
12 (4)
12 (7)
aGreater than 5% in 1 group or more.
Note: Examples of systemic antibiotics are doxycycline, minocycline, and cephalexin. Examples of systemic corticosteroids are prednisone, prednisolone, and methylprednisolone. Examples of topical corticosteroids are betamethasone, hydrocortisone, clobetasol, and prednicarbate. Examples of systemic antihistamines are fexofenadine, ebastine, diphenhydramine, and bepotastine. Examples of topical antibiotics are clindamycin, mupirocin, erythromycin, and terramycin. Examples of emollients and protectives are emollient creams, white soft paraffin, and petrolatum. Examples of topical antifungals are ciclopirox olamine, ketoconazole, metronidazole, and terbinafine. Examples of antiacne preparations are isotretinoin, benzoyl peroxide/clindamycin, and nadifloxacin. An example of other dermatologic preparations is pyrithione zinc. Examples of antiseptics and disinfectants are silver nitrate and lactic acid lotion.

Guidelines for the Medical Management of Paronychia in the PAPILLON, MARIPOSA-2, AND MARIPOSA Studies

The information provided in this section summarizes interventions investigators in the phase 3 studies were instructed to perform to manage paronychia.12-14 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.

Prophylaxis Recommendations12-14

  • Avoid skin irritants.
  • Cushion affected areas.
  • Wear gloves and comfortable shoes.
  • Apply moisturizer to nails.

Reactive Management12-14

Grade 1 Paronychia

  • Use antimicrobial soaks once or twice daily: warm bowl of water + 5 mL of bleach (sodium hypochlorite) or vinegar (DO NOT USE BOTH TOGETHER); soak for 5 minutes, rinse, pat dry, and then apply either emollient or topical treatments below.
  • Apply topical antiseptic (povidone-iodine 10% solution) twice daily.
  • Apply a topical steroid ointment (eg, betamethasone valerate 0.1% or clobetasol) or topical calcineurin inhibitor (eg, tacrolimus 0.1%) twice daily. If using topical steroid, once resolved, switch to topical calcineurin inhibitor daily or decrease to twice per week to maintain.

Grade 2/3 Paronychia

In addition to the guidance for grade 1 paronychia above:

  • Apply topical antibiotic/antifungal agent (eg, mupirocin, fusidic acid, clotrimazole, or miconazole) twice daily.
  • Initiate oral antibiotic for ≥14 days (eg, doxycycline 100 mg twice daily, minocycline 100 mg twice daily, or cephalexin 500 mg twice daily).
  • Consult a dermatologist or podiatrist.

Guidelines for the Medical Management of Paronychia in the CHRYSALIS Study

The information provided in this section summarizes interventions investigators in the CHRYSALIS study were instructed to perform to manage paronychia.15 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.

Reactive Management

  • For paronychia, antiseptic soaks and local potent corticosteroids in addition to oral antibiotics were recommended and, if no improvement was seen, a dermatology or surgery consultation was recommended.15

Best Practices for Prevention and Management of Paronychia Reported in the Literature

The information provided in this section includes best practices for prevention and management of paronychia reported in the literature.16 These are not recommendations for individual patient care. Interventions should be based on patient presentation and the clinical judgment of the treating physician.

  • Discuss lifestyle modifications, which include avoiding the following16:
    • Manicures, pedicures, and artificial nails
    • Drying agents in soaps and makeup (eg, alcohol)
    • Skin irritants
    • Hot showers and baths
    • Gardening
    • Being outdoors and/or sun exposure
  • Dermatology should be consulted early in the treatment for cutaneous toxicities and when initial interventions are not successful or severe cases are observed.
  • Consider the following described in Table: Prevention and Treatment of Paronychia.

Prevention and Treatment of Paronychia16
Prevention
Treatment
Medications:
  • Topical unscented creams or ointments (eg, petroleum jelly)
  • Oral doxycycline or minocycline
  • Topical chlorhexidine

Other interventions:
  • Monitor for signs and symptoms of infections
Medications:
  • Topical antibiotics - clindamycin 1% lotion
  • Topical soaking recipe - vinegar, soap, or bleach soak
  • Oral antibiotics - doxycycline or culture-guided antibiotics if infection is suspected
  • If rash is not relieved by topical and oral antibiotics and no infection is suspected, topical and/or oral steroids are recommended

Other interventions:
  • Silver nitrate sticks and/or debridement for more advanced cases
  • Wear cotton socks with pads when necessary
  • Use liquid bandage for small cuts to prevent infections
  • Consult infectious disease when indicated

Literature Search

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and DerwentDrug File (and/or other resources, including internal/external databases) was conducted on 09 October 2024.

References

1 Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.  
2 Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small cell lung cancer. Future Oncol. 2022;18(6):639-647.  
3 Janssen Research & Development, LLC. A phase 3, randomized study of amivantamab and lazertinib combination therapy versus osimertinib versus lazertinib as first-line treatment in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 October 09]. Available from: https://clinicaltrials.gov/study/NCT04487080 NLM Identifier: NCT04487080.  
4 Cho BC, Lu S, Felip E, et al. Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med. 2024;391:1486-1498.  
5 Janssen Research & Development, LLC. A randomized, open-label phase 3 study of combination amivantamab and carboplatin-pemetrexed therapy, compared with carboplatin-pemetrexed, in patients with EGFR exon 20ins mutated locally advanced or metastatic non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 October 09]. Available from: https://clinicaltrials.gov/study/NCT04538664 NLM Identifier: NCT04538664.  
6 Zhou C, Tang KJ, Cho BC, et al. Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051.  
7 Janssen Research & Development, LLC. A phase 3, open-label, randomized study of amivantamab and lazertinib in combination with platinum-based chemotherapy compared with platinum-based chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer after osimertinib failure. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 October 09]. Available from: https://clinicaltrials.gov/study/NCT04988295 NLM Identifier: NCT04988295.  
8 Passaro A, Wang J, Wang Y, et al. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024;35(1):77-90.  
9 Park K, Haura EB, Leighl NB, et al. Amivantamab in EGFR exon 20 insertion-mutated non-small cell lung cancer progressing on platinum chemotherapy: initial results from the CHRYSALIS phase I study. J Clin Oncol. 2021;39(30):3391-3402.  
10 Garrido P, Girard N, Cho B, et al. Long-term efficacy, safety and predictors of response to amivantamab among patients with post-platinum EGFR ex20ins-mutated advanced NSCLC. Oral Presentation presented at: European Lung Cancer Congress (ELCC); March 29-April 1, 2023; Copenhagen, Denmark.  
11 Singh-Kandah S, Wang K, Xia K, et al. Cutaneous toxicities with amivantamab for non-small cell lung cancer: a practical guide and best practices. Clin J Oncol Nurs. 2024;28(6):1-8.  
12 Passaro A, Wang J, Wang Y, et al. Clinical Protocol for: Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024;35(1):77-90.  
13 Data on File. MARIPOSA Clinical Protocol. Janssen Research & Development, LLC. EDMS-RIM-130080; 2023.  
14 Zhou C, Tang KJ, Cho BC, et al. Clinical Protocol for: Amivantamab plus chemotherapy in NSCLC with EGFR exon 20 insertions. N Engl J Med. 2023;389(22):2039-2051.  
15 Park K, Haura EB, Leighl NB, et al. Supplement to: Amivantamab in EGFR exon 20 insertion-mutated non-small cell lung cancer progressing on platinum chemotherapy: initial results from the CHRYSALIS phase I study. J Clin Oncol. 2021;39(30):3391-3402.  
16 Singh-Kandah S, Wang K, Xia K, et al. Supplement to: Cutaneous toxicities with amivantamab for non-small cell lung cancer: a practical guide and best practices. Clin J Oncol Nurs. 2024;28(6):1-8.  
17 Cho BC, Lu S, Felip E, et al. Supplementary Appendix for: Amivantamab plus lazertinib in previously untreated EGFR-mutated advanced NSCLC. N Engl J Med. 2024;391:1486-1498.