Combining Sunvozertinib with chemotherapy for advanced lung cancer after TKI failure

Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I/II (WU-KONG36)

This study is testing if combining a new drug called Sunvozertinib with chemotherapy can help people with advanced lung cancer who didn't respond to previous treatments.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sichuan University (Academic / other)
• Drugs / interventions: chemotherapy, Sunvozertinib
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06195189 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness, safety, and tolerability of Sunvozertinib in combination with chemotherapy for patients with advanced or metastatic non-small-cell lung cancer (NSCLC) who have EGFR mutations and have not responded to standard TKI therapy. It is a single-arm study that aims to provide insights into how this combination treatment can impact tumor response. The study will include patients aged 18 and older with specific EGFR mutations and measurable disease, while monitoring for adverse effects and overall treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with advanced NSCLC harboring specific EGFR mutations who have progressed after TKI therapy.

Not a fit: Patients with spinal cord compression, meningeal metastasis, or those with known resistant mutations that have approved therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced lung cancer who have limited treatment choices after TKI failure.

How similar studies have performed: While the combination of targeted therapies and chemotherapy is a common approach, this specific combination of Sunvozertinib and chemotherapy in this patient population is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. To provide a signed and dated, written informed consent.
2. 80≥Age ≥ 18 years old
3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
5. Predicted life expectancy ≥ 12 weeks
6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
7. No previous systemic chemotherapy for advanced or metastatic disease.
8. Adequate organ system function:
9. Patient must have measurable disease according to RECIST 1.1.
10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled

Exclusion Criteria:

1. Spinal cord compression or meningeal metastasis
2. A history of malignant tumors within 2 years.
3. With known resistant mutations that have approved target therapy
4. Recover from AEs caused by previous treatment
5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
6. Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)

Where this trial is running

Chengdu, Sichuan

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: You Lu, MD — West China Hospital
• Study coordinator: Li Li, BA

Conditions Non Small Cell Lung Cancer; Sunvozertinib; EGFR; chemotherapy