NSCLC, Stage III
Conditions
Keywords
Locally Advanced, Unresectable NSCLC, TGF-βRI, PD-1
Brief summary
This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).
Interventions
DRUGGFH018
Administered as oral
DRUGToripalimab
Administered as an IV infusion
DRUGPaclitaxel
Administered as an IV infusion
DRUGCarboplatin
Administered as an IV infusion
DRUGCisplatin
Administered as an IV infusion
DRUGPemetrexed
Administered as an IV infusion
RADIATIONThoracic Radiation Therapy (TRT)
Thoracic Radiation Therapy (TRT)
Sponsors
Genfleet Therapeutics (Shanghai) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Primary Purpose: ORR
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Newly diagnosed, pathologically (histologically or cytologically) confirmed, locally advanced, unresectable stage III NSCLC * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 * Measurable disease (according to RECIST v1.1 criteria) * Life expectancy \> 6 months
Exclusion criteria
* Has small cell lung cancer (SCLC) or tumors with the presence of small cell elements. * Has received prior treatment (chemotherapy, targeted therapy, or radiotherapy) for Stage III NSCLC * Prior exposure to immune-mediated therapy, including but not limited to, TGFβ inhibitors, anti CTLA-4, anti-PD-1, anti-PD-L1, and anti PD L2 antibodies. * Known allergy or hypersensitivity to any of the IPs or any of the IP excipients. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | From the date of enrolment of the first patient up to 28 months , which is also16 months after the enrolment of the last patient | Objective response rate (ORR) is defined as the percentage of patients with objective response (OR). OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans. |
Countries
China
Outcome results
None listed