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Trial Title:
Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
NCT ID:
NCT06299371
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab IV
Arm group label:
neoadjuvant immuno-chemotherapy
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
paclitaxel for injection (albumin bound)
Description:
paclitaxel for injection (albumin bound) IV
Arm group label:
neoadjuvant immuno-chemotherapy
Other name:
Nab-paclitaxel
Intervention type:
Drug
Intervention name:
Cisplatin or Carboplatin
Description:
Cisplatin or Carboplatin IV
Arm group label:
neoadjuvant immuno-chemotherapy
Summary:
This is a prospective, single-arm study to investigate the efficacy and safety of
Adebrelimab in combination with paclitaxel for injection (albumin bound) and platinum
chemotherapy as neoadjuvant therapy in resectable non-small cell lung cancer harboring
driver gene mutations
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female aged ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
- Resectable non-small cell lung cancer harboring driver gene mutations.
- At least one measurable disease based on Response Evaluation Criteria in Solid
Tumors 1.1.
- Have adequate organ function.
- Female subjects of childbearing potential must have a negative urine or serum
pregnancy test within 72 hours prior to receiving the first dose of study
medication；Females should not be breastfeeding；Female subjects of childbearing
potential as well as males sexually active with women of childbearing potential must
be willing to use an adequate method of contraception.
- Voluntarily comply with the treatment protocol.
Exclusion Criteria:
- Previously treated with any anti-tumor therapy;
- Subject with known autoimmune disease
- Subject with known history of testing positive for human immunodeficiency virus
(HIV) or known to have acquired immunodeficiency syndrome (AIDS), subject has known
active hepatitis B or C.
- Presence of third space effusion that cannot be controlled by drainage or other
means (e.g., excessive pleural fluid and ascites).
- Subject with severe liver and kidney dysfunction.
- Subjects who need to use corticosteroids (>10 mg/day prednisone or equivalent dose
of similar drugs) or other immunosuppressive therapy for systematic treatment within
14 days before the first administration of the study
- Subject with previous malignancies within 5 years, except for cured in situ cancer.
- Subject with previous or current pulmonary fibrosis, interstitial pneumonia,
pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe damage to
lung function.
- Subject with uncontrolled hypertension.
- Prior organ transplantation including allogenic stem-cell transplantation.
- Known hypersensitivity to the study drug or any of its excipients.
- Other situations that the investigator considers unsuitable for the enrollment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 15, 2024
Completion date:
April 15, 2029
Lead sponsor:
Agency:
Liaoning Tumor Hospital & Institute
Agency class:
Other
Source:
Liaoning Tumor Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06299371
