Sintilimab Combined With Docetaxel for Standard Chemotherapy Failure Non-driver Gene Mutation Metastatic Non-small Cell Lung Cancer

Yongchang Zhang

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Sintilimab Combined With Docetaxel Monotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04144582

STORM

Details and patient eligibility

About

The purpose of this study is to assess the safety and effectiveness of Sintilimab Combined With Docetaxel in Non-driver Gene Mutation NSCLC patients who failed with double platinum-based chemotherapy

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life expectancy exceeds 3 months
• The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard.

Exclusion criteria

• small cell lung cancer or small cell lung cancer
• Currently involved in interventional clinical research or treatment, or have received other research drugs or used research equipment within 4 weeks prior to the first dose;
• Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (eg, CTLA-4, OX-40, CD137);

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Sintilimab Combined With Docetaxel

Experimental group

Description:

Sintilimab Combined With Docetaxel for Metastatic or Non-driver Gene Mutation Non-small Cell Lung Cancer

Treatment:

Drug: Sintilimab Combined With Docetaxel Monotherapy