NCT07507188

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Amivantamab SC + Lazertinib PO	• Amivantamab SC plus Lazertinib PO: 28-day Cycles * Amivantamab 1600/2240 mg SC QW up to C2D1 and Q2W thereafter; * Lazertinib 240 mg PO QD
DRUG	Amivantamab SC + Chemotherapy (Carboplatin IV & Pemetrexed IV)	* Amivantamab SC plus Chemotherapy: 21-day Cycles 1-4 * Amivantamab 1600/2240 mg SC C1D1; 2400/3360 mg C1D8, C1D15, and Day 1 of Cycles 2, 3, 4 * Pemetrexced 500 mg/m2 IV Day 1 * Carboplatin AUC5 IV Day 1 * Amivantamab SC plus Chemotherapy: 21-day Cycles 5+ * Amivantamab 2400/3360 mg SC Day 1 * Pemetrexed 500 mg/m2 IV Day 1

Timeline

• Start date: 2026-04-06
• Primary completion: 2031-01-31
• Completion: 2031-01-31
• First posted: 2026-04-02
• Last updated: 2026-04-02