Last reviewed · How we verify

NCT06747169

Efficacy and Safety of Sintilimab Combined with Nab-PP Plus Rh-endostatin in Locally Advanced/advanced and Recurrent Metastatic Squamous Non-small Cell Lung Cancer: a Single-arm, Multicenter Clinical Study

Not yet recruiting Phase 2 Last updated 27 December 2024
What this trial tests

Phase 2 trial testing Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin in Squamous Non-Small Cell Lung Cancer SqNSCLC in 32 participants. Not yet recruiting.

Timeline
17 December 2024
Primary endpoint
17 December 2026
17 December 2026

Quick facts

Lead sponsorJian-Guo Zhou, MD, PhD
PhasePhase 2
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment32
Start date17 December 2024
Primary completion17 December 2026
Estimated completion17 December 2026

Drugs / interventions tested

Conditions studied

Sponsor

Jian-Guo Zhou, MD, PhD — full company profile →

Who can join

Adults 18 to 70, any sex, with Squamous Non-Small Cell Lung Cancer SqNSCLC. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this single-arm, multi-center phase II clinical study is to evaluate the efficacy and safety of recombinant human endostatin (rh-Endostatin) combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors in patients with locally advanced, advanced, or recurrent metastatic squamous non-small cell lung cancer (NSCLC). The main questions it aims to answer are: What is the progression-free survival (PFS) and objective response rate (ORR) of this combination therapy? What is the safety profile, including adverse event (AE) and serious adverse event (SAE) rates? Researchers will compare the treatment effects over time by evaluating tumor responses using RECIST 1.1 criteria and assessing quality of life using the EORTC QLQ-C30 (v3.0) and QLQ-CX24 scales. Participants will: Receive 4-6 cycles of rh-Endostatin combined with nab-paclitaxel, platinum-based chemotherapy, and PD-1 inhibitors. Continue maintenance treatment with rh-Endostatin and PD-1 inhibitors until disease progression or intolerable toxicity.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06747169.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing