Amivantamab clinical trials
Amivantamab is named as an intervention in 31 current clinical trials in our USA, Spain, South Korea, France, Italy, China, Germany, Taiwan, UK, Brazil, Japan, Poland, Canada, Turkey, Belgium, Netherlands, Israel, Mexico, Australia, India, Portugal, Sweden, Czechia, Egypt, Austria, Denmark, Switzerland and Singapore registers. 16 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Janssen Research & Development, LLC (20). The most-studied condition is Carcinoma, Non-Small-Cell Lung. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Amivantamab is approved
All regulators →Of the three regulators tracked here, the first to approve Amivantamab was the US, on 21 May 2021. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of partial deep dermal and full-thickness burns (28 Jun 2021, negative)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Amivantamab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Amivantamab works
All drug targets →- Epidermal growth factor receptor erbB1 inhibitor InhibitorTarget: EGFR epidermal growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Hepatocyte growth factor receptor inhibitor InhibitorTarget: MET MET proto-oncogene, receptor tyrosine kinase✓ In ChEMBL and the Guide to Pharmacology
- Colorectal cancerPhase 3
- Head and neck squamous cell carcinomaPhase 3
- Adenoid cystic carcinomaPhase 2
- Cutaneous squamous cell carcinomaPhase 2
- Esophageal cancerPhase 2
- Gastric cancerPhase 2
- Head and neck cancerPhase 2
- Hepatocellular carcinomaPhase 2
- CancerPhase 1
- GlioblastomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297774, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10505, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Amivantamab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Amivantamab. 3 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Amivantamab with carboplatin and pemetrexed for untreated EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer NICE TA1158 | Recommended (Cancer Drugs Fund) | 28 May 2026 | Current |
| Amivantamab with lazertinib for untreated EGFR mutation-positive advanced non-small-cell lung cancer NICE TA1122 | Recommended | 21 Jan 2026 | Current |
| Amivantamab for treating EGFR exon 20 insertion mutation-positive advanced non-small-cell lung cancer after platinum-based chemotherapy NICE TA850 | Not recommended | 14 Dec 2022 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Amivantamab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 5 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: RybrevantEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Amivantamab
31 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Amivantamab in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Amivantamab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
DYNAMIC ” IDentifY the best therapeutic sequeNcing strAtegy in oncogene addICted NSCLC:”
“A multi-arms prospective, randomized phase II study to evaluate the best sequential
therapeutic strategis in patients with metastatic non-small cell lung cancer harboring
targetable genomic driver alterations”
2026-525268-16-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Authorised | Universita' Degli Studi Di Torino | Italy |
|
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination with Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
2025-524816-13-00 · Neoplasms
|
Phase 2 | Ongoing | Janssen Cilag International | Spain |
Amivantamab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
5 single-substance products containing Amivantamab on the HPRA medicines list.
- Rybrevant 1 600 mg solution for injectionJanssen-Cilag International NV · EU/1/21/1594/002
- Rybrevant 2 400 mg solution for injectionJanssen-Cilag International NV · EU/1/21/1594/004
- Rybrevant 2240 mg solution for injectionJanssen-Cilag International NV · EU/1/21/1594/003
- Rybrevant 3 520 mg solution for injectionJanssen-Cilag International NV · EU/1/21/1594/005
- Rybrevant 350 mg concentrate for solution for infusionJanssen-Cilag International NV · EU/1/21/1594/001
Supply shortages
No entry for Amivantamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Amivantamab
24 conditionsAll 24 conditions
| Condition (as registered) | Trials |
|---|---|
| Carcinoma, Non-Small-Cell Lung | 11 |
| Colorectal Neoplasms | 2 |
| Squamous Cell Carcinoma of Head and Neck | 2 |
| Non-Small-Cell Lung Cancer | 1 |
| Carcinoma, Non-small-Cell Lung | 1 |
| Advanced or Metastatic Non-small Cell Lung Cancer | 1 |
| Advanced Stage Solid Tumors | 1 |
| Solid Tumor, Adult | 1 |
| Solid Tumors | 1 |
| EGFR Exon 20 Insertion Mutations | 1 |
| NSCLC | 1 |
| EGFR-mutated NSCLC | 1 |
| Advanced or Metastatic Colorectal Cancer | 1 |
| Leptomeningeal Metastasis From Lung Cancer | 1 |
| Lung Cancer (NSCLC) | 1 |
| Advanced Solid Tumor | 1 |
| Non Small Cell Lung Cancer | 1 |
| Metastatic NSCLC - Non-Small Cell Lung Cancer | 1 |
| Colorectal Cancer | 1 |
| Resectable Colorectal Carcinoma | 1 |
| Penile Squamous Cell Carcinoma | 1 |
| Metastatic Penile Squamous Cell Carcinoma | 1 |
| Non-Small Cell Lung Cancer (NSCLC) | 1 |
| RAS/BRAF Wild-type Advanced Colorectal Cancer Patients | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Amivantamab trials
How many clinical trials are testing Amivantamab?
31 current trials in our USA, Spain, South Korea, France, Italy, China, Germany, Taiwan, UK, Brazil, Japan, Poland, Canada, Turkey, Belgium, Netherlands, Israel, Mexico, Australia, India, Portugal, Sweden, Czechia, Egypt, Austria, Denmark, Switzerland and Singapore registers name Amivantamab (also registered as JNJ-61186372) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Amivantamab trials recruiting patients?
Yes. 16 of the 31 trials are recruiting: 11 with sites in USA, 10 with sites in Spain, 9 with sites in South Korea, 7 with sites in France, 9 with sites in Italy, 9 with sites in China, 9 with sites in Germany, 6 with sites in Taiwan, 6 with sites in UK, 4 with sites in Brazil, 5 with sites in Japan, 5 with sites in Poland, 5 with sites in Canada, 3 with sites in Turkey, 6 with sites in Belgium, 5 with sites in Netherlands, 4 with sites in Israel, 4 with sites in Mexico, 3 with sites in Australia, 3 with sites in India, 2 with sites in Portugal, 3 with sites in Sweden, 1 with sites in Czechia, 1 with sites in Egypt and 1 with sites in Austria. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Amivantamab clinical trials?
Janssen Research & Development, LLC (20), Kumquat Biosciences Inc (1), ORIC Pharmaceuticals (1) and Second Affiliated Hospital, Zhejiang University, School of Medicine (1), among 12 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Amivantamab licensed in Ireland?
Yes. The HPRA medicines list includes 5 single-substance products containing Amivantamab, for example Rybrevant 1 600 mg solution for injection (Janssen-Cilag International NV). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Amivantamab shortage?
Not in the lists we track: Amivantamab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Amivantamab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Amivantamab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Amivantamab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.