Unresectable Stage III NSCLC
Conditions
Brief summary
This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Detailed description
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.
Interventions
DRUGDurvalumab
Durvalumab (intravenous infusion)
Carboplatin /Paclitaxel, as per standard of care
Pemetrexed / Cisplatin, as per standard of care
Pemetrexed / Carboplatin , as per standard of care
RADIATIONRadiation
5 fractions/ week for \ 6 weeks (±3 days) (Total 60 Gy)
Sponsors
Shandong Cancer Hospital and Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade ≥3 immune-mediated Adverse event | From the date of first dose until disease progression,assessed up to 4 years | Grade ≥3 immune-mediated Adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From date of first dose until the date of objective disease progression or death,assessed up to 4 years | Progression-free survival |
| Overall Survival (OS) | From the date of first dose until death due to any cause,assessed up to 4 years | Overall Survival |
| Objective response rate(ORR) | From the date of first dose until the date of objective disease progression or death,assessed up to 4 years | Objective response rate |
| Disease control rate(DCR) | From the date of first dose until 24 weeks. | Disease control rate |
| Time to death or distant metastasis(TTDM) | From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years | Time to death or distant metastasis |
| Duration of response(DOR) | From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years | Duration of response |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | From the date of enrollment until disease progression,assessed up to 4 years | Adverse events |
Countries
China
Contacts
Primary ContactJinming Yu, professor
Backup ContactFeifei Teng, physician
Outcome results
None listed