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

Overview

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

Interventions

• Drug Adebrelimab
  Adebrelimab IV
• Drug paclitaxel for injection (albumin bound)
  paclitaxel for injection (albumin bound) IV
• Drug Cisplatin or Carboplatin
  Cisplatin or Carboplatin IV

Primary outcome measures

• Pathological complete response rate [Time frame: at 12 months]

Secondary outcome measures (6)

• Major pathologic response rate [Time frame: 12 months]
• R0 rate [Time frame: 12 months]
• Event Free Survival [Time frame: up to 5 years]
• Overall Survival [Time frame: up to 5 years]
• Objective response rate [Time frame: 12 months]
• Adverse Events [Time frame: up to 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06299371 · MA-NSCLC-II-033

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗