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)

Sponsor
Yonsei University
Study ID
NCT07507188
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab SC + Lazertinib PO — DRUG
    • 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
  • Amivantamab SC + Chemotherapy (Carboplatin IV & Pemetrexed IV) — DRUG
    * 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

Study Details

* 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).

Key Dates

Start date
Apr 6, 2026
Status verified
Mar 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    • No prior exposure to 1st, 2nd, or 3rd EGFR TKIs
  • Experimental: Cohort 2
    • Disease progression after prior treatment with 3rd generation (3G) EGFR TKI (including osimertinib, lazertinib)

Primary Outcome Measure

• scRNA-seq and/or spatial RNA sequencing analysis. Multiplex IHC and/or FACS analysis. [ Time Frame: through study completion, an average of 5 year ]

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