Thanh Pho Vinh

Researchers are evaluating the safety and effectiveness of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as initial treatments for patients with metastatic non-squamous non-small cell lung cancer (mNSCLC) whose tumors express PD-L1. This Phase III, randomized, double-blind, global study focuses on patients whose tumors meet the PD-L1 expression threshold of 1% or higher and do not have certain genetic mutations or rearrangements that would require other targeted therapies. Participants receive either rilvegostomig or pembrolizumab intravenously on the first day of each 21-day treatment cycle. Both groups also receive platinum-based chemotherapy drugs such as carboplatin or cisplatin, administered intravenously up to four cycles, along with pemetrexed given intravenously on Day 1 of each cycle. The study monitors these treatments as first-line therapy for metastatic non-squamous NSCLC. During the study, participants undergo regular assessments including imaging scans to measure tumor size and response, as well as evaluations of organ and bone marrow function. Researchers track overall survival and progression-free survival for up to approximately five years. Safety is closely monitored throughout, and patients are followed long-term to assess outcomes related to treatment effectiveness and tolerability.

This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).

The trial investigates the use of volrustomig in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not shown disease progression after receiving definitive concurrent chemoradiotherapy (cCRT). The study aims to evaluate the efficacy and safety of volrustomig compared to observation in this patient population. Participants have tumors that express PD-L1 and the study is conducted as a Phase III, randomized, open-label, multi-center global trial. Participants are assigned to receive either volrustomig as sequential therapy following cCRT or to an observation group. The treatment period involves monitoring participants who have completed definitive cCRT but remain unresected and have no evidence of metastatic disease. The study focuses on participants with Stage III, IVA, or IVB LA-HNSCC according to AJCC criteria, who have not undergone tumor resection before cCRT and have not been treated with radiotherapy alone. During the study, participants are regularly evaluated for progression-free survival, with follow-up lasting up to approximately 8 years to assess long-term outcomes. Researchers will monitor safety and disease progression closely. The overall participation duration includes screening, treatment or observation, and extended follow-up to capture both efficacy and safety data over time.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

This trial investigates the safety and effectiveness of rilvegostomig combined with fluoropyrimidine and trastuzumab deruxtecan (T-DXd) compared to trastuzumab, chemotherapy, and pembrolizumab in adults with HER2-positive locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 with a combined positive score of 1 or higher. Additionally, rilvegostomig combined with trastuzumab and chemotherapy is studied separately to understand each component's contribution. This Phase 2, randomized, open-label, global study is conducted at 200-250 sites in about 25 countries. Participants are randomly assigned to one of three arms: Arm A receives rilvegostomig, fluoropyrimidine, and T-DXd; Arm B receives trastuzumab, chemotherapy, and pembrolizumab; Arm C receives rilvegostomig, trastuzumab, and chemotherapy. Treatments are administered mostly by intravenous infusion every three weeks, with capecitabine given orally twice daily. The study compares these treatment regimens to evaluate their effects on the cancer. Throughout the study, participants undergo assessments including tumor measurements, organ function tests, and heart function evaluation to ensure safety and monitor disease progression. The main outcomes measured are progression-free survival and overall survival for up to approximately six years. Researchers will also monitor adverse events and overall health status during and after treatment.

Researchers are evaluating the effectiveness and safety of AZD0901 compared to Investigator's choice of therapy for adults with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma expressing Claudin18.2. This Phase III, global, multi-center, open-label, randomized study also includes an assessment of the Ventana CLDN18.2 assay as a diagnostic tool to identify patients who might benefit from AZD0901 treatment. Participants are randomly assigned to receive either AZD0901 at two different dose levels (with enrollment for the second dose level closed) or Investigator's choice of therapy. The comparator therapies include ramucirumab plus paclitaxel, paclitaxel alone, docetaxel, irinotecan, TAS-102 (oral), or apatinib (oral, China only), with dosing schedules varying by drug. Treatments are given intravenously or orally according to specific regimens and cycles. Participants will be involved in assessments measuring progression-free survival and overall survival for up to about three years from their first dose or randomization. Researchers will monitor disease progression, survival, safety, and the clinical performance of the diagnostic test. The study includes regular evaluations, imaging, and laboratory tests to track treatment effects and participant health throughout the study period.

This research investigates the effectiveness and safety of combining capivasertib with CDK4/6 inhibitors and fulvestrant in adults with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer that is locally advanced, inoperable, or metastatic. It includes a Phase Ib dose-finding portion to establish safe dosages for the triple combination, followed by a Phase III study comparing this combination to CDK4/6 inhibitors plus fulvestrant alone. The study focuses on patients who have not received prior endocrine therapy for advanced disease and aims to assess added benefit in a high-risk population. During Phase Ib, participants receive capivasertib orally twice daily for 4 days followed by 3 days off each week, combined with fulvestrant injections and one of the CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib) at varying doses to find the recommended dose for Phase III. In Phase III, participants are randomized to receive capivasertib plus fulvestrant and a CDK4/6 inhibitor at the established dose or fulvestrant plus a CDK4/6 inhibitor alone, with dosing schedules maintained over 28-day cycles. Participants undergo regular monitoring including scans for tumor assessment, blood tests, and safety evaluations over extended periods—up to 47 months for progression-free survival assessment. Researchers track adverse events, serious side effects, and treatment tolerability throughout. Mandatory tumor and blood samples are collected for biomarker analysis. The study evaluates key outcomes such as dose-limiting toxicities, treatment-related adverse events, and progression-free survival, supporting long-term safety and effectiveness evaluation.

Researchers are evaluating the safety and effectiveness of combining trastuzumab deruxtecan (T-DXd) with rilvegostomig compared to standard treatments in patients with advanced HER2-expressing biliary tract cancer who have not received prior therapy. This phase 3 study focuses on patients with locally advanced or metastatic disease and aims to measure overall survival and safety outcomes. Participants will receive one of the following treatments: the experimental combination of T-DXd and rilvegostomig by intravenous infusion, T-DXd alone, or a standard care regimen consisting of gemcitabine, cisplatin, and durvalumab given intravenously. The study includes a safety run-in period to assess tolerability of the combination, followed by a randomized phase where patients receive assigned treatments. Each treatment cycle lasts 21 days. During the study, participants will be closely monitored through clinical assessments, laboratory tests, and imaging to evaluate tumor response and safety. Researchers will track overall survival from the time of treatment initiation until death from any cause, with follow-up estimated up to 50 months. Additional assessments include performance status, organ function, and tumor tissue analysis to confirm HER2 expression and other markers. Safety and side effects will be continuously evaluated throughout the study.

Researchers are evaluating the effectiveness and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that tests positive for TROP2 but does not have actionable genomic alterations. This phase III, randomized, open-label, multicenter study also assesses the performance of a new diagnostic device to identify suitable participants. Eligible patients have previously been treated for their cancer and meet specific genomic and disease progression criteria. Participants will receive either datopotamab deruxtecan or docetaxel, both given through intravenous (IV) infusions. The study has two arms comparing these treatments directly. Treatment and monitoring will continue according to the study protocol. The investigational drug, Dato-DXd, is being closely evaluated against the standard chemotherapy drug docetaxel for its impact on disease control. During the study, participants will undergo various assessments including imaging scans to measure tumor response and disease progression. Researchers will monitor progression-free survival over approximately 2.5 years and overall survival over about 3.5 years. Other evaluations include performance status, laboratory tests, and safety monitoring to track side effects and overall health throughout the study period.

Researchers are evaluating the effectiveness and safety of osimertinib tablets combined with Datopotamab Deruxtecan (Dato-DXd) intravenous infusion compared to osimertinib alone as a first treatment for people with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific EGFR gene mutations (Ex19del and/or L858R). This global Phase III, open-label, randomized study focuses on participants who have not received prior therapy for advanced disease. The goal is to show that the combination therapy improves progression-free survival compared to osimertinib alone. Participants will be randomly assigned to receive either osimertinib 80 mg orally once daily or osimertinib plus Dato-DXd at 6 mg/kg given by intravenous infusion every three weeks. Treatment will continue until the disease progresses, unacceptable side effects occur, or other reasons require stopping. Visits for assessments will occur every three weeks during treatment. For those on osimertinib alone or who discontinued Dato-DXd but continue osimertinib, visits will be every six weeks from cycle 7 to cycle 17, then every 12 weeks until disease progression or treatment stops. Participants receiving both drugs will have visits every three weeks. During the study, participants will undergo regular assessments including scans and laboratory tests to monitor their condition and treatment effects. Researchers will track progression-free survival through independent review about three years after the first participant is enrolled. The study is expected to last about eight years, with ongoing monitoring of safety and treatment tolerance throughout. Participants must attend scheduled visits for evaluations and treatment administration as outlined in the study plan.