Lung Cancer
Conditions
Keywords
pd1, PARP
Brief summary
PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). Overall survival (OS).
Detailed description
This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles ). In the Induction Phase, participants receive pd1 plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive PD1 plus maintenance PAPR. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance until centrally verified progressive disease (PD), intolerable toxicities, or physician decision.
Interventions
DRUGPD-1 inhibitor
Tirelizumab
DRUGPARP inhibitor
Fluzopari capsule
Sponsors
Tianjin Medical University Cancer Institute and Hospital
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
* 1 NSCLC confirmed by pathology (histology or cytology) 2\. First line treatment of patients with immune combined with chemotherapy into immune maintenance treatment; 3\. 18-75 years old, both male and female; 2\. There are stage IIIA, IIIB or IIIc NSCLC diagnosed according to the 8th edition of the American Joint Committee on cancer. 3\. Stage III NSCLC that cannot undergo radical surgery was confirmed and recorded by the multidisciplinary tumor committee or the treating physician in consultation with the thoracic surgeon. 4\. In the whole body fluorodeoxyglucose (FDG) - pet or FDG-PET / CT and diagnostic quality CT or MRI scans of the chest, abdomen, pelvis and brain, there was no evidence of metastatic disease as stage IV NSCLC. Note: unless otherwise demonstrated, the presence of pleural / pericardial effusion is considered to indicate metastatic disease. For pleural effusion in both CT chest scan and frontal chest X-ray examination, pleural puncture is required to confirm that the pleural effusion is cytologically negative. Participants whose effusion was exudate were excluded, even if their effusion was cytologically negative. Subjects who have met the remaining inclusion /
Exclusion criteria
, and pleural effusion is not visible on chest X-ray examination in front and side views, or there is too little effusion to be safely extracted can enter the study. 5\. Having a measurable disease as defined in RECIST 1.1, at least one lesion is suitable as a target lesion (determined by the investigator / imaging review of the local research center). 4\. No more than 28 days before the first study, CT or MRI scan, at least one previous target lesion without radiotherapy (recistv1.1). 5\. No previous treatment (chemotherapy, targeted therapy or radiotherapy) for stage III NSCLC. 6\. ECoG physical fitness status is 0 or 2 points. 7\. Life expectancy is at least 12 weeks. 8\. No antiangiogenic drugs or PARP inhibitors have been used in previous treatment; 9\. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved before the screening period Level 10.0-1 (judged according to NCI CTCAE 5.0) or to the level specified in the inclusion /
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 2 years | Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first. |
Countries
China
Outcome results
None listed