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NCT Number: NCT06299371

Adebrelimab Plus Chemotherapy as Neoadjuvant Therapy in Resectable 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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adebrelimab

Drug

Adebrelimab IV

Other names: SHR-1316

paclitaxel for injection (albumin bound)

Drug

paclitaxel for injection (albumin bound) IV

Other names: Nab-paclitaxel

Cisplatin or Carboplatin

Drug

Cisplatin or Carboplatin IV

Primary outcomes

  1. Pathological complete response rate

    Time frame: at 12 months

    pCR rate, the proportion of patients achieved pathologic complete response (lung and lymph node without tumor residual assessed by pathology review)

Secondary outcomes

  1. Major pathologic response rate

    Time frame: 12 months

    MPR rate, the proportion of patients achieved pathologic complete response (lung and lymph node ≤10% tumor residual assessed by pathology review)

  2. R0 rate

    Time frame: 12 months

    the proportion of patients achieved R0(No residue under the microscope after resection)

  3. Event Free Survival

    Time frame: up to 5 years

    EFS, the time length from the first dose to any prescriptive events

  4. Overall Survival

    Time frame: up to 5 years

    OS, the time length from the date of the first dose to the date of death.

  5. Objective response rate

    Time frame: 12 months

    ORR, the proportion of patients achieved complete or partial response

  6. Adverse Events

    Time frame: up to 5 years

    AEs

Study contacts

Contact information is provided by the study sponsor or research team.

Gebang Wang

CONTACT

[email protected]

+8618900918114

Sponsors and collaborators

Lead sponsor

Liaoning Cancer Hospital & Institute

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Mar 7, 2024
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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