Dato-DXd + Pembrolizumab for Non-Small Cell Lung Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
What data supports the effectiveness of the drug combination Dato-DXd + Pembrolizumab for Non-Small Cell Lung Cancer?
Research shows that pembrolizumab, when combined with chemotherapy drugs like carboplatin and pemetrexed, is effective as a first-line treatment for advanced non-small cell lung cancer. Pemetrexed combined with cisplatin has shown a response rate of up to 44.8% in non-small cell lung cancer, indicating that these components can be effective in treating this type of cancer.12345
What safety data exists for Dato-DXd + Pembrolizumab treatment in humans?
Pembrolizumab (Keytruda) has been studied for safety in non-small cell lung cancer, showing some side effects like pneumonitis (lung inflammation) in 1%-5% of patients. Pemetrexed and platinum drugs, when combined with pembrolizumab, have been associated with various side effects, including fatigue, blood and digestive issues, and skin reactions. These treatments have been generally safe but can cause serious side effects in some cases.26789
What makes the drug combination of Dato-DXd and Pembrolizumab unique for treating non-small cell lung cancer?
The combination of Dato-DXd and Pembrolizumab is unique because it includes a novel antibody-drug conjugate, Dato-DXd, which targets a specific protein on cancer cells, potentially enhancing the effectiveness of Pembrolizumab, an existing immunotherapy, in patients with advanced non-small cell lung cancer who have high PD-L1 expression.12101112
What is the purpose of this trial?
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
Research Team
Global Clinical Leader
Principal Investigator
Daiichi Sankyo
Eligibility Criteria
Adults over 18 with advanced non-squamous NSCLC who haven't had systemic cancer treatment, have specific levels of TROP2 and PD-L1 proteins, no major gene mutations treatable by approved therapies, good performance status, and no significant health issues like uncontrolled heart disease or active infections. Pregnant women and those with certain lung diseases or recent vaccinations are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive randomized treatment with Dato-DXd and pembrolizumab with or without platinum chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carboplatin
- Cisplatin
- Datopotamab Deruxtecan
- Pembrolizumab
- Pemetrexed
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?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Daiichi Sankyo, Inc.
Lead Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University