Featured Clinical Trials

Jannet Platonova
Associate Director, Clinical Operations
101 Carnegie Center, Suite 101
Princeton, NJ 08540
Mobile (609) 955-6736
jplatonova@TaihoOncology.com

Full title: Randomized, Controlled, Open-label, Phase 3, Global Multi-Center Trial to Assess the Efficacy and Safety of Zipalertinib plus Chemotherapy versus Chemotherapy alone, in Patients with Previously Untreated, Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

The purpose of this study is to evaluate the safety and efficacy of zipalertinib in combination with standard first-line platinum-based chemotherapy compared to chemotherapy alone in patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations. The study will be conducted in two parts:

• Part A: Safety lead-in to determine the recommended dose of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin), to be studied in Part B of the study.
• Part B: Randomized, controlled, open-label, multinational Phase 3 study to assess the efficacy and safety of zipalertinib in combination with standard chemotherapy with pemetrexed and a platinum agent (either carboplatin or cisplatin) compared to standard chemotherapy alone. An independent data monitoring committee (IDMC) will be established to monitor interim safety data.

Who can participate?

• Greater than 18 years of age
• Confirmed, locally advanced or metastatic nonsquamous NSCLC
• Has not received any prior treatment for their NSCLC
• Ex20ins EGFR mutation in tumor

Kayley Bradley - kbradley@taihooncology.com

This study will evaluate the safety and efficacy of zipalertinib in patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or other uncommon EGFR mutations.

Patients will be enrolled into one of the four following cohorts:

• Cohort A will include patients with EGFR exon 20 insertion mutations who have progressed on or after initial treatment with standard platinum-based chemotherapy and prior treatment with an ex20 agent for their advanced disease (administered together or separately).
• Cohort B will include patients with EGFR exon 20 insertion mutations who have not received prior treatment for advanced disease.
• Cohort C will include patients with EGFR exon 20 insertion mutations or other  mutations and active brain metastases. Patients may or may not have had prior treatment for advanced disease.
• Cohort D will include patients with other EGFR uncommon single or compound mutations who have progressed on or after treatment with standard systemic anticancer therapy.

Who can participate?

• Greater than 18 years of age
• Confirmed, locally advanced or metastatic nonsquamous NSCLC
• Ex20ins EGFR mutation in tumor

1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

The main purpose of this study is to determine whether the investigational drugs zimberelimab (also known as AB122, GS-0122 or ZIM) with domvanalimab (also known as AB154, GS-0154 or DOM) in combination with chemotherapy are safe and effective when given to participants with non small cell lung cancer (NSCLC) when comparing to pembrolizumab (the standard treatment for those with NSCLC) with chemotherapy.

The patient population:

• should have untreated metastatic NSCLC,
• is 18 years and older with life expectancy of ≥ 3 months, and
• their tumors should have no actionable genomic mutations for which there is targeted therapy available.