EGFR-targeted Therapy for Gastric Cancer

National Cancer Center (NCC)

Status and phase: Enrolling; Phase 2

Conditions: Adenocarcinoma of the Stomach

Treatments: Drug: Anti-EGFR antibody in combination with weekly paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04077255

31973

Details and patient eligibility

About

Based on targeted NGS panel results, metastatic gastric cancer patients with gene amplifications will receive either anti-EGFR antibody (GC-1118) in combination with weekly paclitaxel as a second-line therapy.

Full description

Participants will receive each treatment if the gastric cancer tissue sample reveals either EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Enrollment: 19 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key inclusion criteria

1. Histologically-proven gastric and gastroesophageal junction adenocarcinoma
2. Refractory to first-line chemotherapy for metastatic disease
3. Presence of at least 1 measurable lesion according to RECIST version 1.1
4. EGFR gene amplification or strong (3+ or 2+) EGFR immunostaining

Key exclusion criteria

1.Prior exposure to taxane or EGFR-targeted therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

anti-EGFR

Experimental group

Description:

Participants will receive GC-1118 in combination with weekly paclitaxel.

Treatment:

Drug: Anti-EGFR antibody in combination with weekly paclitaxel