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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)

NCT07507188 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-06
Primary Completion
2031-01-31
Completion
2031-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507188 on ClinicalTrials.gov