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Real world study to evaluate paclitaxel liposome / carboplatin combined with PD-1 monoclonal antibody in the first-line treatment of advanced lung squamous cell carcinoma

Real world study to evaluate paclitaxel liposome / carboplatin combined with PD-1 monoclonal antibody in the first-line treatment of advanced lung squamous cell carcinoma

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050475
Enrollment
Unknown
Registered
2021-08-27
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Squamous cell carcinoma of lung

Interventions

Experimental group:Liposome paclitaxel + carboplatin + PD-1

Sponsors

Cancer Hospital of Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Histologically proven stage IIIB/C and IV squamous cell carcinoma (SCC) not suitable for surgery or local therapy; 3. EGFR sensitive mutation and ALK or ROS-1 gene rearrangement were not detected; 4. There are tumor tissue samples available for PD-L1 immunohistochemical examination; 5. The investigator has at least one measurable lesion confirmed by the RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 7. Patients who have received neoadjuvant chemotherapy, adjuvant chemotherapy or concurrent chemoradiotherapy for non-metastatic disease, the interval from the end of the last treatment is at least 6 months, and they have not received systemic anti-tumor therapy after being diagnosed with advanced lung cancer; 8. The main organs function normally; 9. Expected survival time >= 3 months.

Exclusion criteria

Exclusion criteria: 1. Active central nervous system metastasis or meningeal metastasis; 2. Previous therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 drug, or another drug that stimulates or synergistically inhibits T-cell receptors (eg: CTLA-4, OX-40, CD137); 3. There is clinically uncontrollable pleural effusion/peritoneal effusion; 4. Currently participating in interventional clinical research treatment, or receiving other drugs or using research equipment after diagnosis of advanced lung cancer; 5. Active autoimmune disease requiring systemic treatment occurred within 2 years before the first administration; 6. There is any serious or uncontrollable systemic disease; 7. Received >30Gy of pulmonary radiation therapy within 1 month before the first dose.

Design outcomes

Primary

MeasureTime frame
Progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Overal survival;Disease control rate;

Countries

China

Contacts

Public ContactDuan Jianchun

Cancer Hospital of Chinese Academy of Medical Sciences

duanjianchun79@163.com+86 13811259820

Outcome results

None listed

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