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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299371
• Other study ID #: MA-NSCLC-II-033
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 15, 2024
• Est. completion date: April 15, 2029

Study information

• Verified date: February 2024
• Source: Liaoning Tumor Hospital & Institute
• Contact: Gebang Wang
• Phone: +8618900918114
• Email: gebangdan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 15, 2029
• Est. primary completion date: April 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liaoning Tumor Hospital & Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response rate	pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)	at 12 months
Secondary	Major pathologic response rate	MPR rate, the proportion of patients achieved pathologic complete response (lung and lymph node =10% tumor residual assessed by pathology review)	12 months
Secondary	R0 rate	the proportion of patients achieved R0(No residue under the microscope after resection)	12 months
Secondary	Event Free Survival	EFS, the time length from the first dose to any prescriptive events	up to 5 years
Secondary	Overall Survival	OS, the time length from the date of the first dose to the date of death.	up to 5 years
Secondary	Objective response rate	ORR, the proportion of patients achieved complete or partial response	12 months
Secondary	Adverse Events	AEs	up to 5 years