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

NCT ID: NCT06299371

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2029-04-15

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

Conditions

Non Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

neoadjuvant immuno-chemotherapy

Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy

Group Type: EXPERIMENTAL

Adebrelimab

Intervention Type: DRUG

Adebrelimab IV

paclitaxel for injection (albumin bound)

Intervention Type: DRUG

paclitaxel for injection (albumin bound) IV

Cisplatin or Carboplatin

Intervention Type: DRUG

Cisplatin or Carboplatin IV

Interventions

Adebrelimab

Adebrelimab IV

Intervention Type: DRUG

paclitaxel for injection (albumin bound)

paclitaxel for injection (albumin bound) IV

Intervention Type: DRUG

Cisplatin or Carboplatin

Cisplatin or Carboplatin IV

Intervention Type: DRUG

Other Intervention Names

SHR-1316; Nab-paclitaxel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaoning Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Hongxu Liu

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Gebang Wang

Role: CONTACT

gebangdan@hotmail.com

+8618900918114

Other Identifiers

MA-NSCLC-II-033

Identifier Type: -

Identifier Source: org_study_id