Skip to content

Adebrelimab plus Chemotherapy as Perioperative Treatment in Patients With Resectable NSCLCs: An Single-arm, prospective, exploratory clinical study

Adebrelimab plus Chemotherapy as Perioperative Treatment in Patients With Resectable NSCLCs: An Single-arm, prospective, exploratory clinical study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074485
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-08-08
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable NSCLCs

Interventions

Single arm:Adobeilimab puls chemotherapy neoadjuvant therapy, Q3W, 3 cycles radical operation

Sponsors

Anhui Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75, gender unlimited; 2.Primary resectable non-small cell lung cancer of stage IB(=4cm)-IIIA confirmed by histopathology or cytology 3.No previous local or systemic treatment for primary lung cancer; 4. At least one measurable lesion (according to RECIST 1.1); 5. Negative EGFR/ALK driver genes; 6.Ecog ps . 01; 7. Life expectancy = 3 months; 8.The functional level of organs must meet the following requirements: ANC = 1.5×109/L; PLT = 90×109/L; Hb = 90 g/L; TBIL = 1×ULN; ALT and AST = 1.5×ULN, ALP = 2.5×ULN; BUN and Cr = 1× ULN and creatinine clearance = 50 mL/min (Cockcroft-Gault formula); LVEF = 50%; Fridericia corrected QT interval (QTcF) for male < 450 ms and female < 470 ms; INR = 1.5 x ULN, ACTT = 1.5 x ULN. 9.Subjects sign informed consent and voluntarily join the study.

Exclusion criteria

Exclusion criteria: 1.Previous antitumor therapy for primary lung cancer, including chemotherapy, targeting, immunization or radiotherapy; 2.Subjects who are allergic or hypersensitive to therapeutic drugs or have autoimmune diseases; 3.Subjects who are allergic or hypersensitive to therapeutic drugs or have autoimmune diseases; Presence of third space effusion that cannot be controlled by drainage or other means (e.g., excessive pleural fluid and ascites) 4.Steroid treatment for more than 50 days, or long-term use of steroids is required; 5.Uncontrolled symptomatic brain metastases or mental abnormalities that do not correctly state subjective symptoms; 6.Other malignancies developed within 5 years prior to inclusion, except carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin previously treated for radical treatment; 7.Pregnant or lactating women who are fertile but refuse to take contraceptive measures; 8.Patients with severe heart disease or history, including a documented history of congestive heart failure, high-risk uncontrolled arrhythmias, medicated angina, clinically clear valvular heart disease, history of severe myocardial infarction, and intractable hypertension; 9.Have received a tissue/solid organ allograft; 10.Concomitant medical conditions (e.g., uncontrolled hypertension, diabetes, thyroid disease, etc.) that, in the investigator's judgment, pose a serious risk to the subject's safety or affect the subject's ability to complete the study. 11. Other conditions that the researchers determined were not suitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Pathological complete response rate;

Secondary

MeasureTime frame
Major pathological response rate;

Countries

China

Contacts

Public ContactAnqing Zhang

Anhui Provincial Cancer Hospital

1401517021@qq.com+86 138 5651 2825

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026