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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Adebrelimab; Drug: paclitaxel for injection (albumin bound); Drug: Cisplatin or Carboplatin

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gebang Wang; Phone Number: +8618900918114; Email: gebangdan@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: neoadjuvant immuno-chemotherapy; Adebrelimab plus paclitaxel for injection (albumin bound) and platinum chemotherapy	Drug: Adebrelimab; Adebrelimab IV; Other Names: SHR-1316; Drug: paclitaxel for injection (albumin bound); paclitaxel for injection (albumin bound) IV; Other Names: Nab-paclitaxel; Drug: Cisplatin or Carboplatin; Cisplatin or Carboplatin IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
R0 rate	the proportion of patients achieved R0(No residue under the microscope after resection)	12 months
Event Free Survival	EFS, the time length from the first dose to any prescriptive events	up to 5 years
Overall Survival	OS, the time length from the date of the first dose to the date of death.	up to 5 years
Objective response rate	ORR, the proportion of patients achieved complete or partial response	12 months
Adverse Events	AEs	up to 5 years

Collaborators and Investigators

• Sponsor: Liaoning Tumor Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2024
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 15, 2029

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel; Albumin-Bound Paclitaxel
• Other Study ID Numbers: MA-NSCLC-II-033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No