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A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan(T-DXd) and Durvalumab in Combination with Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth FactorReceptor 2 Overexpression (HER2+) (DESTINY-Lung03)

Recruitment Status
Recruiting
Project Status
Ongoing
Project Description
This is an open-label, multi-center, dose-escalation Phase Ib study to evaluate the safety, tolerability and RP2D of T-DXd with durvalumab plus cisplatin, carboplatin or pemetrexed in patients with non-squamous HER2+ (IHC 3+/2+) mNSCLC. Patients must have RECIST v1.1 evaluable disease and ECOG PS . . .
Primary Sponsor
AstraZeneca AB
Study Type
Observational
Date of Registration
12 June 2021
Date of FIrst Enrollment
01 September 2021
Region
Sweden
Method of Allocation
Non-Randomized
Masking
Open Label
Assignment
Single
Phase
Phase I
FDA Clinical Trial Reference (CTR) Number
2021-CT0591
Sources of Monetary or Material Support
AstraZeneca Pharmaceuticals (Philippines) Inc.
Primary Outcomes

To assess the safety and tolerability (and to determine the RP2D) of T-DXd plus durvalumab in combination with cisplatin, carboplatin, or pemetrexed.

Key Inclusion and Exclusion Criteria
For inclusion in the study, patients should fulfil the following criteria and must not enter thestudy if any of the criteria are not fulfilled: Informed Consent1 Capable of giving signed informed consent as described in Appendix A, which includes compliance with the requiremen . . .
Countries of Recruitment
Belgium, Canada, France, Italy, Netherlands, Philippines, Singapore, South Korea, Spain, Taiwan, Thailand, United States
Health Condition(s) or Problem(s) Studied

Patients with Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression 


Results 541 - 541 of 541
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