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Metronomic chemotherapy (NVB) combination with Tislelizumab in EGFR/ ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy: a single-arm phase II clinical trial

Metronomic chemotherapy (NVB) combination with Tislelizumab in EGFR/ ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy: a single-arm phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061304
Enrollment
Unknown
Registered
2022-06-20
Start date
2022-07-01
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

lung cancer

Interventions

case series:NA

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Non-small cell lung cancer diagnosed by histopathology or cytology; molecular pathology (tissue, ARMS method or NGS) negative for EGFR and ALK (genetic testing may not be performed in patients with squamous lung cancer); stage IV diagnosis confirmed by imaging; no prior antitumor therapy; intolerance to standard-dose chemotherapy as determined by the investigator: 1) age > 75 years; 2) ECOG score >= 2; 3) Those with comorbid underlying disease not amenable to platinum-containing two-drug chemotherapy; measurable or evaluable lesions according to RECIST 1.1 criteria; patients were fully informed of this study and voluntarily signed a written informed consent; expected survival > 3 months.

Exclusion criteria

Exclusion criteria: Tumor histology or cytologic pathology confirmed combined small cell lung cancer component; patients with cranial metastases with neurological or psychiatric symptoms; patients with asymptomatic brain metastases could be enrolled; those with oral drug impairment; and other conditions that the investigator considered not eligible for enrollment.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
objective response rate;disease control rate;

Countries

China

Contacts

Public ContactZhiyong He
heyong1015@163.com+86 13805086391

Outcome results

None listed

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