About the study

This is an open -label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Vactosertib in Combination with durvalumab in patients advanced NSCLC who progressed following platinum-based chemotherapy.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at enrollment
2. Histological or cytological confirmation of advanced NSCLC who progressed following platinum-based chemotherapy.
3. Confirmation of measurable disease based on RECIST 1.1 by investigators
4. No prior exposure to immune-mediated therapy .
5. In dose escalation phase, 6 DLT evaluable patients whose tumor cell PD-L1 expression less than 25% will be enrolled in each cohort. In dose expansion phase, 45 patients with confirmed PD-L1-positive NSCLC by the Ventana SP263 IHC assay will be enrolled
6. All patients must be able to provide an available tumor sample taken ≤3 years prior to screening
7. Adequate organ and marrow function
8. Must have a life expectancy of at least 12 weeks
9. Body weight >30 kg

Exclusion criteria

1. History of allogeneic organ transplantation.
2. Active or prior documented autoimmune or inflammatory disorders
3. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure .
4. History of another primary malignancy
5. History of active primary immunodeficiency
6. Brain metastases or spinal cord compression.
7. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥450 ms in male and ≥470 ms in female
8. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
9. Receipt of the last dose of anticancer therapy (chemotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, or monoclonal antibodies) ≤ 3 weeks prior to the first dose of study drug
10. Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment
11. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
12. Major surgical procedure
13. Current or prior use of immunosuppressive medication within 14 days.
14. The prohibited medications
15. Participation in another clinical study with an investigational product administered in the last 30 days
16. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.