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

NCT06299371 | Not Yet Recruiting Phase 2

• 1 other identifier: MA-NSCLC-II-033
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Major pathologic response rate

  12 months

• R0 rate

  12 months

• Event Free Survival

  up to 5 years

• Overall Survival

  up to 5 years

• Objective response rate

  12 months

Study Arms (1)

neoadjuvant immuno-chemotherapy

EXPERIMENTAL

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

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

Interventions

Adebrelimab DRUG

Adebrelimab IV

Also known as: SHR-1316

neoadjuvant immuno-chemotherapy

paclitaxel for injection (albumin bound) DRUG

paclitaxel for injection (albumin bound) IV

Also known as: Nab-paclitaxel

neoadjuvant immuno-chemotherapy

Cisplatin or Carboplatin DRUG

Cisplatin or Carboplatin IV

neoadjuvant immuno-chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Paclitaxel; Injections; 130-nm albumin-bound paclitaxel; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Central Study Contacts

Gebang Wang

CONTACT

+8618900918114; gebangdan@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 7, 2024
• Study Start: April 15, 2024
• Primary Completion: April 15, 2026
• Study Completion (Estimated): April 15, 2029
• Last Updated: March 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share