Clinical Trial

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)

Study acronym: INSTAR
Not Yet Recruiting Phase 2
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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).
Trial Details
NCT Number NCT07507188
Lead Sponsor Yonsei University
Conditions Non Small Cell Lung Cancer
Enrollment 80 participants
Start Date 2026-04-06
Primary Completion 2031-01-31 (estimated)
Study Completion 2031-01-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-02