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JIN-A02 Plus Amivantamab in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Failure

NCT07798921 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-09-02

No results posted yet for this study

Summary

This Phase 1 study will evaluate the safety, maximum tolerated dose, recommended Phase 2 dose, and preliminary antitumor activity of JIN-A02 in combination with amivantamab in participants with advanced EGFR-mutant non-small cell lung cancer whose disease has progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor.

The study includes a dose-escalation phase and a dose-expansion phase. During dose escalation, participants will receive oral JIN-A02 once daily at planned dose levels of 120 mg, 160 mg, or 200 mg in combination with weight-based intravenous amivantamab. Dose escalation will follow a Bayesian optimal interval design, and dose-limiting toxicities during the first 28-day treatment cycle will be used to determine the maximum tolerated dose and recommended Phase 2 dose.

After the recommended Phase 2 dose is determined, additional participants will be enrolled in the dose-expansion phase to further evaluate safety and preliminary antitumor activity. Efficacy assessments will include objective response rate and progression-free survival according to RECIST version 1.1. Exploratory analyses may evaluate changes in EGFR mutations and resistance-associated genomic alterations using circulating tumor DNA collected before and during treatment and at the end of treatment.

Conditions

  • Carcinoma
  • Non-Small-Cell Lung

Interventions

DRUG

JIN-A02 in Combination with Amivantamab

Participants will receive oral JIN-A02 once daily in continuous 28-day treatment cycles in combination with intravenous amivantamab. During dose escalation, the planned JIN-A02 dose levels are 120 mg, 160 mg, and 200 mg once daily. Amivantamab will be administered at 1,050 mg for participants with a baseline body weight of less than 80 kg or 1,400 mg for participants weighing 80 kg or more. The first amivantamab dose will be split between Cycle 1 Days 1 and 2, followed by administration on Days 8, 15, and 22 of Cycle 1 and every 2 weeks from Cycle 2 onward. On combination-treatment days, JIN-A02 will be administered within approximately 15 minutes before amivantamab.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-28
Primary Completion
2028-06-01
Completion
2030-12-31

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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 NCT07798921 on ClinicalTrials.gov