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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
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.
17 December 2026
Quick facts
| Lead sponsor | Jian-Guo Zhou, MD, PhD |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 17 December 2024 |
| Primary completion | 17 December 2026 |
| Estimated completion | 17 December 2026 |
Drugs / interventions tested
- Sintilimab, albumin-bound paclitaxel plus platinum agent (Nab-PP), and recombinant human endostatin — full drug profile →
Conditions studied
- Squamous Non-Small Cell Lung Cancer SqNSCLC — all drugs for Squamous Non-Small Cell Lung Cancer SqNSCLC →
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:
- PubMed search for NCT06747169
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- ASCO Meeting Library
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06747169 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jian-Guo Zhou, MD, PhD
- Last refreshed: 27 December 2024
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.
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