A Study to Evaluate the Safety of Concurrent Durvalumab With CRT Followed by Durvalumab for Chinese Unresectable Stage III NSCLC

Launched by SHANDONG CANCER HOSPITAL AND INSTITUTE · Jul 28, 2021

Keywords

ClinConnect Summary

Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects with histologically or cytologically-documented NSCLC
• • Locally advanced, unresectable (Stage III) NSCLC
• • World Health Organization (WHO) performance status 0-1
• • At least one measurable lesion, not previously irradiated
• • Must have a life expectancy of at least 12 weeks at randomization
• • Adequate lung function: Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or \>40% predicted value and DLCO \>30% predicted value
• • Must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy.
• Exclusion Criteria:
• • Mixed small-cell and NSCLC histology
• • Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
• • Prior exposure to immune-mediated therapy, including but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
• • Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume
• • Planned radiation cardiac dose V50\>25%
• • Any medical contraindication of platinum-based doublet chemotherapy as listed in the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients
• • History of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency
• • Uncontrolled intercurrent illness or active infection