Therapy Detail
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| Therapy Name | Amivantamab-vmjw + Lazertinib |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Amivantamab-vmjw | Rybrevant | JNJ-61186372 | EGFR Antibody 60 MET Antibody 31 | Rybrevant (amivantamab-vmjw) is a bi-specific antibody that targets EGFR and MET, resulting in inhibition of downstream signaling and potentially leading to decreased growth of EGFR and/or MET-expressing tumors (PMID: 27216193, PMID: 32414908). Rybrevant (amivantamab-vmjw) is FDA-approved for use in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy, in combination with carboplatin and pemetrexed as first-line therapy for adult patients with NSCLC harboring EGFR exon 20 insertion mutations and for patients harboring EGFR exon 19 deletion or L858R who progressed on prior EGFR TKI, and in combination with Lazcluze (lazertinib) as first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR exon 19 deletions or EGFR L858R (FDA.gov). |
| Lazertinib | Lazcluze | GNS 1480|YH25448|JNJ-73841937|JNJ73841937|JNJ 73841937|YH 25448|YH-25448 | EGFR Inhibitor 3rd gen 26 | Lazcluze (lazertinib) is an irreversible protein kinase inhibitor with selective activity against mutant EGFR, which may lead to growth inhibition of EGFR-mutant tumor cells and reduced toxicity (PMID: 30670498, PMID: 32599977). Lazcluze (lazertinib) is FDA approved in combination with Rybrevant (amivantamab-vmjw) as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 19 deletions or EGFR L858R (FDA.gov) |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04077463 | Phase I | Amivantamab-vmjw + Lazertinib Amivantamab-vmjw + Carboplatin + Lazertinib + Pemetrexed Disodium Amivantamab-vmjw Lazertinib | A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer (Chrysalis-2) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 5 |
| NCT05498428 | Phase II | Amivantamab-vmjw Amivantamab-vmjw + Lazertinib Amivantamab-vmjw + Carboplatin + Pemetrexed Disodium Amivantamab-vmjw + Carboplatin + Lazertinib + Pemetrexed Disodium | A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (PALOMA-2) | Recruiting | USA | ITA | ISR | GBR | FRA | ESP | DEU | BRA | 4 |
| NCT02609776 | Phase I | Amivantamab-vmjw Amivantamab-vmjw + Carboplatin + Pemetrexed Disodium Amivantamab-vmjw + Lazertinib | Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer (CHRYSALIS) | Active, not recruiting | USA | GBR | FRA | ESP | CAN | AUS | 4 |
| NCT04965090 | Phase II | Amivantamab-vmjw + Lazertinib | A Study of Amivantamab and Lazertinib in People With Non-Small Cell Lung Cancer (NSCLC) | Active, not recruiting | USA | 0 |
| NCT04606381 | Phase I | Amivantamab-vmjw + Lazertinib Amivantamab-vmjw + Lazertinib + rHuPH20 Amivantamab-vmjw Amivantamab-vmjw + rHuPH20 | A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (PALOMA) | Active, not recruiting | USA | GBR | CAN | 1 |
| NCT05388669 | Phase III | Amivantamab-vmjw + Lazertinib | A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3) | Active, not recruiting | USA | TUR | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | AUS | ARG | 7 |
| NCT04487080 | Phase III | Amivantamab-vmjw + Lazertinib Lazertinib Osimertinib | A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA) | Active, not recruiting | USA | TUR | POL | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS | ARG | 12 |
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