Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable NSCLC Harboring Driver Gene Mutations

Liaoning Tumor Hospital & Institute

Status and phase

Not yet enrolling

Phase 2

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: Cisplatin or Carboplatin

Drug: paclitaxel for injection (albumin bound)

Drug: Adebrelimab

Study type

Interventional

Funder types

Other

Identifiers

NCT06299371

MA-NSCLC-II-033

Details and patient eligibility

About

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

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.