Table of contents
- Clinical trials overview
- Lung cancer studies
- Colorectal cancer studies
- Head and neck cancer studies
- Other solid tumor studies
- What the trials measure
- Who may join these trials
Clinical trials overview
The trial data show that Amivantamab is being studied in many cancer settings, mainly non-small cell lung cancer, colorectal cancer, and head and neck squamous cell carcinoma.[1][2][3]
These studies include Phase 1, Phase 2, Phase 3, and one Phase 4 trial.[1][2][3] Early phases focus more on safety, dose selection, and how the treatment is tolerated, while later phases compare how well treatment works against standard care.[2][3]
Lung cancer studies
Most of the trials in this data are in non-small cell lung cancer (NSCLC), which is a common type of lung cancer.[1] Many of these studies focus on people with EGFR mutations, which are changes in a gene that can help cancer grow.[1]
Some trials study Amivantamab before surgery in people with resectable NSCLC, meaning the cancer can still be removed by surgery.[1] In NCT06784791, the main goal is to see how many patients can have curatively intended surgery within 43 days of starting study treatment.[1]
Several Phase 3 studies compare Amivantamab-based treatment with standard treatment in locally advanced or metastatic EGFR-mutated NSCLC.[1] These studies measure progression-free survival (PFS), which is the time before the cancer gets worse, and use RECIST v1.1, a standard scan-based method for checking tumor size.[1]
One large trial compares Amivantamab plus lazertinib with osimertinib as first-line treatment, while another compares Amivantamab plus platinum-based chemotherapy after osimertinib failure.[1] Another study looks at Amivantamab in people with EGFR exon 20 insertion mutations, a specific type of EGFR change.[1]
There are also studies testing different ways to give Amivantamab, including subcutaneous injection, which means under the skin, and intravenous infusion, which means through a vein.[1] One Phase 3 study checks whether subcutaneous Amivantamab with lazertinib is noninferior to intravenous Amivantamab, meaning it works at least as well.[1]
Some lung cancer trials also study side effects and supportive care. For example, one Phase 2 study looks at ways to reduce dermatologic adverse events, which are skin side effects, and another studies how to reduce infusion-related reactions during the first dose.[1]
Colorectal cancer studies
Amivantamab is also being studied in advanced or metastatic colorectal cancer, including tumors that are KRAS/NRAS and BRAF wild-type, which means these genes do not have certain changes.[2] Some studies focus on left-sided colorectal cancer, and others include recurrent, unresectable, or metastatic disease.[2]
Two large Phase 3 trials compare Amivantamab-based treatment with cetuximab-based standard regimens.[2] Their main goals are to measure progression-free survival and overall survival, which is how long patients live after treatment starts.[2]
There is also a Phase 1b/2 study in advanced or metastatic colorectal cancer that tests Amivantamab alone and with standard chemotherapy.[2] In that study, the main focus includes objective response rate, which means how many tumors shrink or disappear, and safety when Amivantamab is added to chemotherapy.[2]
These colorectal cancer studies are important because they try to find the best treatment for people whose cancer has spread or returned and who may need new options after standard therapy.[2]
Head and neck cancer studies
Several trials study Amivantamab in head and neck squamous cell carcinoma, a cancer that starts in the lining of the mouth, throat, or nearby areas.[3] Some studies include people whose disease has come back or spread, while others include treatment-naïve patients, meaning they have not yet received treatment for the recurrent or metastatic setting.[3]
One Phase 1b/2 study tests Amivantamab alone and in combination with other treatments such as pembrolizumab, carboplatin, and paclitaxel.[3] The goals include finding the recommended dose, checking safety, and measuring anti-tumor activity using objective response rate and other endpoints.[3]
Another Phase 3 study compares Amivantamab added to standard of care with standard of care alone in recurrent or metastatic head and neck cancer.[3] Its main endpoint is overall survival, so the study is trying to learn whether the Amivantamab group lives longer.[3]
Other solid tumor studies
Some trials include broader groups of advanced solid tumors, which means cancers that form a solid mass and have spread or cannot be removed easily.[4] These studies are often “basket” or parallel cohort trials, meaning different patient groups are studied in separate groups within one trial.[4]
One Phase 2 study looks at subcutaneous Amivantamab in multiple regimens for advanced or metastatic solid tumors, including EGFR-mutated NSCLC.[4] Its main endpoint is objective response rate by investigator review, which means the study doctor checks how many patients respond.[4]
Another Phase 1 study tests Amivantamab with capmatinib in unresectable metastatic NSCLC, with early parts focused on dose selection and safety, and later parts focused on tumor response in tumors with MET exon 14 skipping or MET amplification.[5] A different Phase 1 study tests Amivantamab with cetrelimab in metastatic NSCLC and looks at safety, dose-limiting toxicities, and response.[6]
One Phase 2 trial in advanced solid tumors is a modular basket study that measures response in small, molecularly selected patient groups.[7] This type of study helps researchers match a treatment to a specific tumor feature rather than only to one cancer type.[7]
What the trials measure
The main endpoints across these studies include objective response rate, progression-free survival, overall survival, and the chance of having surgery on time in preoperative studies.[1][2][3]
Some trials also measure safety outcomes such as adverse events, dose-limiting toxicities, and skin reactions.[3][6] In one study, researchers specifically track the rate of infusion-related reactions within 24 hours of the first infusion.[8]
Several studies use central review of scans, including blinded independent central review, to make the results more reliable.[1][2] This means the scan results are checked by experts who do not know which treatment the patient received.[1]
Who may join these trials
Eligibility depends on the cancer type, stage, and tumor gene changes listed in each study.[1][2][3] Many trials include adults with locally advanced, metastatic, recurrent, or unresectable disease, while some studies are for people who can still have surgery.[1][3]
Some studies require prior treatment, such as after osimertinib failure or after platinum-based chemotherapy and PD-1/PD-L1 therapy, while others are first-line studies for treatment-naïve patients.[3][5] This means the trials are testing Amivantamab at different points in the treatment journey.[3]
In short, the trial program is broad and aims to learn where Amivantamab may fit best: before surgery, after prior treatment, or together with other cancer medicines in selected patient groups.[1][2][3]
