Last updated: August 1, 2021
Sponsor: Shandong Cancer Hospital and Institute
Overall Status: Active - Recruiting
Phase
2
Condition
N/ATreatment
N/AClinical Study ID
NCT04982549
D4191L00116
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 1.0L or >40% predicted value and DLCO >30% predicted value
- Must provide an archived tumor tissue block(or at least 15 newly cut unstainedslides)≤3 years old; if archived sample unavailable then must provide a recent(≤3months) tumor biopsy.
Exclusion
Exclusion Criteria:
- Mixed small-cell and NSCLC histology
- Receipt of prior or current cancer treatment, including but not limited to, radiationtherapy, 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 wholelung 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 thelocal labelling or known allergy/hypersensitivity to investigational product and/orits excipients
- History of the following: allogeneic organ transplantation, active or prior autoimmuneor inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis,active primary immunodeficiency
- Uncontrolled intercurrent illness or active infection
Study Design
Total Participants: 35
Study Start date:
January 21, 2021
Estimated Completion Date:
March 01, 2023
Study Description
Connect with a study center
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai 200000
ChinaActive - Recruiting

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