Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus C… (NCT07507188) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Collaborative Clinical-translational Cohort of Amivantamab Plus Lazertinib and Amivantamab Plus Chemotherapy in Patients With EGFR-mutant, Locally Advanced or Metastatic/Recurrent Non-Small Cell Lung Cancer (INSTAR Study)
80 participantsStarted 2026-04-06
Plain-language summary
* In this study, we hypothesized that immune engagement by amivantamab will enhance antitumor efficacy by modulating the immune microenvironment in combination with lazertinib in patients with untreated EGFR-mutant NSCLC or with chemotherapy (carboplatin plus pemetrexed) after progression with 3rd generation (3G) EGFR TKI.
* The primary objective of this study is to examine the patients' tumors for immunomodulatory effects of amivantamab-based regimens.
* In a phase 2, two cohort clinical trial, treatment naïve patients with EGFR-mutant NSCLC will be treated with amivantamab SC plus oral lazertinib (Cohort 1, n=30) or patients with EGFR-mutant NSCLC progressed on or after 3G EGFR TKI treated with amivantamab SC plus chemotherapy (Cohort 2, n=30).
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 19 years and older
. Provision of informed consent prior to any study specific procedures
. Histologically or cytologically confirmed Locally advanced, Recurrent, or Metastatic NSCLC, performed on a biopsy and able to do a paired biopsy during treatment (C3D1)
. Documented activating EGFR mutation (Exon 19 deletion or L858R)
. Measurable disease defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
. Resolution of all acute toxic effects of prior chemotherapy, radiotherapy or surgical procedures to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: ≤ grade 1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Leptomeningeal carcinomatosis or uncontrolled central nervous system (CNS) metastases
. Symptomatic spinal cord compression that has not been treated definitively with surgery or radiation
. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
. Patients who are known to be serologically positive for human immunodeficiency virus (HIV)
. Participant has concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Principal Investigator:
. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.
. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.