272 Participants Needed

Zipalertinib + Chemotherapy for Non-Small Cell Lung Cancer

(REZILIENT3 Trial)

Recruiting at 113 trial locations
TO
Overseen ByTaiho Oncology, INC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot take medications that strongly affect CYP3A4 enzymes within 7 days before starting the trial. It's best to discuss your current medications with the trial team.

What makes the drug Zipalertinib unique for treating non-small cell lung cancer?

Zipalertinib is a novel treatment option for non-small cell lung cancer that targets specific genetic mutations in cancer cells, potentially offering a more personalized approach compared to traditional chemotherapy. This drug is designed to inhibit certain proteins that help cancer cells grow, making it different from standard treatments that do not target these specific mutations.12345

What data supports the effectiveness of the drug Zipalertinib + Chemotherapy for Non-Small Cell Lung Cancer?

Research on similar drugs like osimertinib, which is used for non-small cell lung cancer with specific mutations, shows that combining it with chemotherapy can improve survival rates. This suggests that combining Zipalertinib with chemotherapy might also be effective.12678

Are You a Good Fit for This Trial?

Adults with advanced non-small cell lung cancer (NSCLC) that have a specific mutation called EGFR exon 20 insertion. They must be over 18, have stable brain metastases if present, an ECOG performance status of 0 or 1, and a life expectancy of at least three months. Participants should not have had prior systemic treatment for their NSCLC except certain adjuvant/neoadjuvant therapies over six months ago.

Inclusion Criteria

I have at least one tumor that can be measured if I'm enrolling in Part B.
I haven't had systemic treatment for my advanced non-squamous NSCLC, but early-stage treatments over 6 months ago are okay.
I can provide a sample of my tumor for testing.
See 10 more

Exclusion Criteria

I had cancer before, but it's either been treated or stable for over 2 years.
I haven't had certain treatments or major surgery within the last month.
I have serious heart problems, including heart failure or irregular heartbeat.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-In

Determine the recommended dose of zipalertinib in combination with standard chemotherapy

21 days per cycle, until progressive disease or withdrawal
Rolling-6 design, multiple visits

Phase 3 Treatment

Randomized, controlled, open-label study to assess efficacy and safety of zipalertinib with chemotherapy

21 days per cycle, carboplatin or cisplatin for 4 cycles, until progressive disease or withdrawal
Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Zipalertinib
Trial Overview The trial is testing the effectiveness and safety of a new drug named Zipalertinib in combination with standard platinum-based chemotherapy versus chemotherapy alone in patients with advanced NSCLC harboring the EGFR exon 20 insertion mutation.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Group II: Part A (Safety Lead in)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Taiho Oncology, Inc.

Lead Sponsor

Trials
79
Recruited
12,700+

Tim Whitten

Taiho Oncology, Inc.

Chief Executive Officer since 2018

MBA and Pharmacy degree

Harold Keer

Taiho Oncology, Inc.

Chief Medical Officer

MD, PhD

Published Research Related to This Trial

In a study of 170 patients with advanced non-squamous non-small-cell lung cancer, axitinib combined with pemetrexed and cisplatin showed a higher objective response rate (45.5% and 39.7%) compared to chemotherapy alone (26.3%).
While the combination therapy did not significantly improve progression-free survival compared to chemotherapy alone, it was generally well tolerated, with hypertension being the most common serious side effect in the axitinib groups.
Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer.Belani, CP., Yamamoto, N., Bondarenko, IM., et al.[2021]
In the AZENT study involving 22 patients with advanced non-small-cell lung cancer (NSCLC) and a specific EGFR mutation, first-line treatment with osimertinib resulted in a high objective response rate of 77.3%, indicating its efficacy in this patient population.
The median progression-free survival (PFS) was 23.1 months, suggesting that osimertinib can provide significant disease control for patients with coexisting low allelic fraction of the EGFR Thr790Met mutation.
First-line osimertinib in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met.Majem, M., Sullivan, I., Viteri, S., et al.[2022]
The combination of osimertinib and platinum-based chemotherapy (OPP) demonstrated a high objective response rate of 90.9% in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer, indicating strong efficacy.
The treatment was well-tolerated, with no treatment-related deaths and an acceptable safety profile, as only 14.9% of patients discontinued due to adverse events.
Phase 2 study of osimertinib in combination with platinum and pemetrexed in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer: The OPAL Study.Saito, R., Sugawara, S., Ko, R., et al.[2023]

Citations

Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. [2021]
First-line osimertinib in patients with epidermal growth factor receptor-mutant non-small-cell lung cancer and with a coexisting low allelic fraction of Thr790Met. [2022]
Phase 2 study of osimertinib in combination with platinum and pemetrexed in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer: The OPAL Study. [2023]
Phase I trial of axitinib combined with platinum doublets in patients with advanced non-small cell lung cancer and other solid tumours. [2021]
Osimertinib Versus Comparator EGFR TKI as First-Line Treatment for EGFR-Mutated Advanced NSCLC: FLAURA China, A Randomized Study. [2022]
Lung Cancer Driven by BRAFG469V Mutation Is Targetable by EGFR Kinase Inhibitors. [2022]
Mobocertinib in non-small cell lung cancer. [2022]
Dabrafenib plus trametinib in patients with previously untreated BRAFV600E-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. [2022]
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