Clinical trial NCT06299371: Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations
Official title: A Prospective, Single-arm Study of Adebrelimab in Combination With Paclitaxel for Injection (Albumin Bound) and Platinum Chemotherapy as Neoadjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) Harboring Driver Gene Mutations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Liaoning Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


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.

Primary outcomes:
measure: Pathological complete response rate
timeFrame: at 12 months
Secondary outcomes:
measure: Major pathologic response rate
timeFrame: 12 months
measure: R0 rate
timeFrame: 12 months
measure: Event Free Survival
timeFrame: up to 5 years
measure: Overall Survival
timeFrame: up to 5 years
measure: Objective response rate
timeFrame: 12 months
measure: Adverse Events
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References: