A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

• Status: Recruiting
• Trial end date: 2024-06-23
• Target enrollment: 0
• Participant gender: All

Summary

Researchers are looking for a better way to treat advanced Triple-Negative Breast Cancer (TNBC) and Non-Small-Cell Lung Cancer (NSCLC). "Advanced" usually means that the cancer keeps growing even with treatment. The cancer may also be "metastatic", which means that it has spread to other parts of the body or the surrounding tissue.

The study drug, Datopotamab deruxtecan, is designed to work by attaching to the tumor cells and stopping the tumor growth. Datopotamab deruxtecan is also known as Dato-DXd.

In this study, the researchers want to find out how well Dato-DXd works to stop tumors from growing in Chinese participants with NCSLC or TNBC. This is the first time Dato-DXd is being studied in Chinese population.

Participants in this study will get Dato-DXd through a needle as an injection. They will get 1 dose of Dato-DXd every 3 weeks until their cancer gets worse or they leave the study for another reason.

Participants will visit their study sites at least once every 3 weeks for as long as they are in the study. The study doctors will take blood samples every 3 weeks and take images of the participants' tumors every 6 weeks until the participant leaves the study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo, Inc.

Criteria

Key Inclusion Criteria:

• Capable of giving signed informed consent.

• Participant must be ≥ 18 years at the time of screening.

• Eastern Cooperative Oncology Group performance status of 0 or 1.

• At least one lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline and can be accurately measured at baseline and is suitable for accurate repeated measurements.

Additional Inclusion Criteria for Cohort 1 (NSCLC):

• Histologically or cytologically documented Stage IIIB or IIIC NSCLC disease not amenable for surgical resection or definitive chemoradiation or Stage IV NSCLC disease at the beginning of study intervention.

• Documented negative test results for EGFR and ALK genomic alterations. If test results for EGFR and ALK are not available, participants are required to undergo testing performed locally for these genomic alterations.

• Participants must meet one of the required prior therapy requirements for advanced or metastatic NSCLC.

Additional Inclusion Criteria for Cohort 2 (TNBC)

• Pathologically documented oestrogen and progesterone receptor-negative and HER2-negative expression.

• Inoperable locally advanced or metastatic breast cancer.

• Received at least 2 prior chemotherapy regimens for locally advanced or metastatic breast cancer and previously treated with a taxane in any setting.

Key Exclusion Criteria:

• Has leptomeningeal carcinomatosis or metastasis

• Has clinically significant corneal disease

• Has known active hepatitis or uncontrolled hepatitis B or C infection

• Has a history of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

• Prior exposure to specific therapies without an adequate treatment washout period prior to enrolment.

Additional Exclusion Criteria for Cohort 1 (NSCLC):

• Has mixed SCLC and NSCLC histology.