Investigating a new treatment for advanced lung cancer with EGFR mutations

An Open Label, Multicenter, Phase 1/2 Study to Explore the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of TRX-221 in the Treatment of Patients With EGFR Mutant NSCLC Who Progressed Following Prior Therapy With EGFR TKI

This study is testing a new oral treatment for advanced lung cancer in patients with EGFR mutations who haven't responded to standard therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Therapex Co., Ltd (industry)
• Drugs / interventions: osimertinib, chemotherapy, Immunotherapy
• Locations: 6 sites (Chungju, Chungbuk and 5 other locations)
• Trial ID: NCT06186076 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 open-label study aims to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of TRX-221 in patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations. Eligible participants will receive the treatment orally once daily until disease progression or other discontinuation criteria are met. The study specifically targets patients who have previously failed standard treatments, including approved EGFR tyrosine kinase inhibitors (TKIs).

Who should consider this trial

Good fit: Ideal candidates include patients with relapsed or refractory advanced NSCLC with specific EGFR mutations who have progressed after prior TKI treatments.

Not a fit: Patients who have not received prior EGFR TKI treatments or those with early-stage lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced EGFR mutant NSCLC who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting EGFR mutations in NSCLC, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients with ECOG performance status score of 0 or 1
2. Histologically or cytologically confirmed diagnosis of relapsed or refractory, locally unresectable advanced or metastatic NSCLC harboring an activating EGFR mutation
3. Failed standard of care treatments progressed after anti tumor treatments including at least 1 approved EGFR TKI \[Phase2: TKIs should include the approved EGFR TKIs with activity against T790M (e.g., osimertinib)\]
4. Slots may be reserved for patients with certain resistant mutations (i.e., EGFR C797X mutation with or without T790M mutation as required by the sponsor) \[Phase 1\]
5. EGFR C797X mutation with or without T790M mutation \[Phase 2\]
6. Not received more than 1 prior line of platinum based chemotherapy in the metastatic setting \[Phase 2\]
7. Having at least 1 measurable tumor lesion per RECIST v1.1 criteria \[Phase 2\]
8. Having adequate bone marrow, hepatic, and renal function as specified in the protocol

Exclusion Criteria:

1. NSCLC with mixed cell histology or a tumor with histologic transformation of small cell elements
2. Patients having tumor with any additional known driver of alterations
3. Patients with presence of another active primary malignant tumor that has been diagnosed or required therapy within 2 years prior to the initiation of the study treatment
4. Patients who have unstable and symptomatic primary CNS tumors/metastasis, leptomeningeal metastases or spinal cord compression which are not suitable for enrollment, as judged by the Investigator
5. Patients having clinically active ongoing ILD of any etiology
6. Clinically significant cardiac conditions, infections, refractory GI diseases as specified in the protocol
7. Patients having any unresolved toxicities from prior anti tumor therapy and surgery greater than CTCAE Grade 1 at the time of starting the study treatment
8. Recent anticancer therapy: EGFR-TKI, Immunotherapy or any other systemic anticancer therapy or radiotherapy (specific duration prior to starting study medication per protocol)

Where this trial is running

Chungju, Chungbuk and 5 other locations

• Chungbuk National University Hospital — Chungju, Chungbuk, Korea, Republic of (RECRUITING)
• Seoul National University Bundang Hospital — Seongnam, Kyeongki, Korea, Republic of (ACTIVE_NOT_RECRUITING)
• The Catholic University of Korea St. Vincent Hospital — Suwon, Kyeongki, Korea, Republic of (ACTIVE_NOT_RECRUITING)
• Severance Hospital — Seoul, Korea, Republic of (RECRUITING)
• Asan Medical Center — Seoul, Korea, Republic of (RECRUITING)
• Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)

Study contacts

• Study coordinator: Therapex Co., Ltd Clinical Development

Conditions: Carcinoma, Non-Small-Cell Lung, EGFR Mutant Advanced Non-Small Cell Lung Cancer