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

NCT04840290 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-04-21

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer

Interventions

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

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Principal Investigators

  • YANG SONG, MD · Tang-Du Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2023-06-01
Completion
2023-06-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840290 on ClinicalTrials.gov