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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Participants will receive T-DXd as an IV infusion Q3W, on Day 1 of each 3-week cycle.

The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients with HER2 Mutant NSCLC

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An Open-label, Single-arm, Phase 2 Study to Evaluate the Efficacy and Safety of Trastuzumab Deruxtecan (T-DXd) for Patients with HER2-mutant Metastatic NSCLC who have Disease Progression on or after at Least One-line of Treatment (DESTINY-Lung05)

Confirmed ORR, defined as the proportion of participants with confirmed complete response or partial response, as assessed by independent central review(ICR) based on RECIST 1.1.

Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator at local site per RECIST 1.1

DoR is time from the initial confirmed response (CR or PR) until documented tumour progression or death from any cause.

DCR is the proportion of participants who achieved confirmed CR, PR, or SD during study intervention.

PFS is the time from date of enrolment until first objective radiographic tumour progression or death from any cause.

OS is the time from date of enrolment until death from any cause.

CNS-PFS is the time from date of enrolment until CNS tumour progression per RECIST 1.1 as assessed by ICR due to any cause in the absence of CNS progression.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for T-DXd.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for total anti-HER2 antibody.

Individual patient data and descriptive statistics will be provided for serum concentration data at each time point for DXd.

Presence of ADAs against T-DXd in serum during treatment and at follow-up.

Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0.

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients with HER2 Mutant NSCLC - DL-05

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