NCT04840290

A Neoadjuvant Study of Sintilimab Plus Platinum Doublet Chemotherapy in IIIA(N2) Stage NSCLC

A Neoadjuvant Study of Sintilimab Plus Platinum Doublet Chemotherapy in IIIA(N2) Stage Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the feasibility and evaluate the safety of delivering chemotherapy, the usual approach to non-small cell lung cancer, in combination with Sintilimab (PD-1 antibody), followed by adjuvant therapy after surgical resection. Consolidation therapy is treatment given following the initial treatment. Sintilimab is an investigational drug, which has been approved by the NMPA(National Medical Products Administration,China. https://www.nmpa.gov.cn/) for use in late stage of non-small cell lung cancer (NSCLC). Sintilimab is a monoclonal antibody that binds to the surface of some cells of the immune system and activates them against cancer cells. It is not chemotherapy.

Detailed description

The primary hypothesis is that the addition of Sintilimab to neoadjuvant concurrent chemotherapy, followed by consolidation Sintilimab, will be safe and feasible to deliver to patients with resectable stage 3A Non-small cell lung cancer (NSCLC). This study also plans to observe the efficacy of this combination in the overall and biomarker-positive population. Study Design This is an open-label, single arm phase III trial of neoadjuvant chemotherapy + Sintilimab with concurrent radiation followed by surgical resection and consolidation Sintilimab in resectable stage 3A (N2+) NSCLC. Eligible patients will have biopsy-confirmed T1-3N2M0 (stage IIIA) non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC not otherwise specified), performance status 0-1, adequate lung function and deemed medically resectable by a thoracic surgeon, adequate organ function for chemotherapy, and no contraindications to Sintilimab (i.e. autoimmune disorders or underlying pulmonary fibrosis).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Biological: Sintilimab Drug: Cisplatin Drug: Paclitaxel for Injection (Albumin Bound) Drug: Carboplatin	Biological: Sintilimab Drug: Cisplatin Drug: Paclitaxel for Injection (Albumin Bound) Drug: Carboplatin

Timeline

• Start date: 2019-06-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2021-04-09
• Last updated: 2021-04-21

Locations

1 site across 1 country: China