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Exploratory clinical study of PD-1 inhibitor combined with chemotherapy (albumin paclitaxel combined with carboplatin for three weeks) in the treatment of advanced non-small cell lung cancer

Exploratory clinical study of PD-1 inhibitor combined with chemotherapy (albumin paclitaxel combined with carboplatin for three weeks) in the treatment of advanced non-small cell lung cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045209
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-04-08
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

lung cancer

Interventions

Sponsors

The Fifth Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in clinical research and sign written informed consent. 2. Aged 18-75 years, no gender limits. 3. Patients with stage IIIb-IV NSCLC diagnosed by histology or cytology have measurable tumor foci without chemotherapy. 4. According to recist1.1, there is at least one tumor lesion that can be repeatedly measured. 5. The expected survival time is more than 3 months. 6. ECOG status score was 0-2. 7. Organ function level must meet the following requirements: (1) Hematological indexes: absolute neutrophil count >= 1.5 x 10^9 / L, platelet count >= 75 x 10^9 / L, hemoglobin >= 80 g / L; (2) Liver function: total bilirubin <= 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT) <= 2.5 x ULN; (3) Renal function: serum creatinine level <= 1.5 x ULN; (4) Blood coagulation function: INR, Pt and APTT <= 1.5 times the upper limit of normal value; (5) The ECG was normal. 8. Female subjects of childbearing age must conduct serum pregnancy test within 3 days before the first administration and the result is negative. If they have sex with male partners who are not sterilized, they must take effective contraceptive methods from the beginning of screening to 120 days after the last administration, if they have sex with female partners who are not sterilized, they must take contraceptive methods from the beginning of screening to 120 days after the last administration Choose an acceptable and effective contraceptive method.

Exclusion criteria

Exclusion criteria: 1. Any unstable systemic disease (including acute infection, major cardiovascular disease {including myocardial infarction in the past year}, any serious liver, kidney or metabolic disease), metabolic disorder. 2. Except for four types of malignant tumors that can be radically resected, including cervical cancer in situ, basal or squamous cell skin cancer, intraductal carcinoma in situ (breast), and organ-limited prostate cancer, with any other malignant tumors within 5 years. 3. (Researchers believe) Patients who may transmit human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) through blood or other body fluids should be excluded. 4. Lactating and / or pregnant women.

Design outcomes

Primary

MeasureTime frame
Objective remission rate;

Secondary

MeasureTime frame
Progress Free Survival;

Countries

China

Contacts

Public ContactLin Zhong

The Fifth Affiliated Hospital of Sun Yat-Sen University

linzhong123@163.com+86 13570604449

Outcome results

None listed

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