TAK-788 vs Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare effectiveness of TAK-788 as first-line treatment with that of platinum-based chemotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors has epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Participants will be randomly assigned to one of the two treatment groups- TAK-788 group or Platinum-based chemotherapy group. Participants will receive TAK-788 orally and pemetrexed/cisplatin or pemetrexed/carboplatin via vein until the participants experience worsening disease (PD) as assessed by blinded independent review committee (IRC), intolerable harmful effects or another discontinuation criteria.
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot take certain medications like moderate or strong CYP3A inhibitors or inducers within 10 days before starting TAK-788. Also, you should not be on medications known to cause torsades de pointes.
What data supports the effectiveness of the drug TAK-788 for non-small cell lung cancer?
Research shows that drugs like pemetrexed and cisplatin, which are part of the treatment being compared to TAK-788, have been effective in treating non-small cell lung cancer (NSCLC). Pemetrexed combined with cisplatin is a standard treatment for advanced NSCLC, suggesting that TAK-788 is being compared to a well-established and effective regimen.12345
What safety data exists for TAK-788 and platinum-based chemotherapy in humans?
How is TAK-788 different from other drugs for non-small cell lung cancer?
TAK-788 is a novel drug being compared to traditional platinum-based chemotherapy, which includes drugs like carboplatin and cisplatin, for treating non-small cell lung cancer. Unlike standard treatments, TAK-788 may offer a different mechanism of action, potentially targeting specific mutations in cancer cells, which could make it more effective for certain patients.234910
Research Team
Study Director
Principal Investigator
Takeda
Eligibility Criteria
Adults with advanced non-squamous NSCLC and specific EGFR exon 20 mutations, who haven't had systemic treatment for advanced disease. They should have a life expectancy of at least 3 months, an ECOG performance status of 0-1, adequate organ function, and no other primary malignancies or conditions like spinal cord compression.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive TAK-788 or platinum-based chemotherapy until disease progression or intolerable toxicity
Follow-up
Participants are monitored for survival, subsequent anticancer therapy, and health status
Open-label extension (optional)
Participants in the chemotherapy group may cross over to treatment with TAK-788 after disease progression
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Pemetrexed
- TAK-788
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Millennium Pharmaceuticals, Inc.
Lead Sponsor
Dr. Christophe Bianchi
Millennium Pharmaceuticals, Inc.
Chief Medical Officer since 2006
MD from University of Geneva
Dr. Deborah Dunsire
Millennium Pharmaceuticals, Inc.
Chief Executive Officer since 2005
MD from University of Witwatersrand
Takeda
Lead Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier