Biomarkers to Predict the Response to Pembrolizumab in Chinese NSCLC Patients

NCT04076228 | Completed FDA Drug

• 1 other identifier: KWH201702
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Pembrolizumab is approved for advanced stage non-small cell lung cancer. However, the response rate is low (around 10-15 %) in patients treated in Macau SAR, China. The investigators hypothesize CD38 expressing cells and/or other immune populations will help to predict response.

Conditions

NSCLC Stage IV

Keywords

NSCLC; PD-L1; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Overall response rate

  To assess the real world effectiveness of pembrolizumab treatment in locally advanced or metastatic NSCLC patients with PD-L1 positive in terms of response rate

  Disease response is assessed every 3 weeks for the first 18 weeks and then every 12 weeks until disease progression (worsens) or study completion, an average of 24 months.

Study Arms (1)

Pembrolizumab

Chinese lung cancer patients who will receive pembrolizumab will be enrolled in this study. Clinically, the treatment course of pembrolizumab is depended on the efficacy, but average cycle is about 3-4 weeks and patient will receive 6 treatment courses.

Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

pembrolizumab is a PD-1 inhibitor. Treatment and follow up will be performed at Kiang Wu Hospital in their clinical oncology center. Clinically pathological related information will be recorded.

Pembrolizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study cohort will include locally advanced or metastatic NSCLC patients with PD-L1 status available and receive pembrolizumab treatment per the judgement of treating physicians in the participating site in Macau. 30-40 patients are anticipated to be enrolled in the study, the majority of which are estimated to be from mainland China.

You may qualify if:

• Above 18 years of age
• Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
• With PD-L1test available
• Progressed on previous treatment, or treatment native patients. Patients may have also received additional lines of treatment
• Received pembrolizumab treatment in the participating site.

You may not qualify if:

• Enrollment in studies that prohibit any participation in this observational study
• No serum samples available

Sponsors & Collaborators

• Kiang Wu Hospital: lead

Study Sites (1)

Kiang Wu Hospital

Macao, 999078, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

7 ml of whole blood from patients and donor will be collected. Blood samples will be stored in EDTA-coating tube. PBMC will be isolated using a density gradient technique. Whole blood will be processed using standard protocol.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yabing Cao, MD; PhD

  Kiang Wu Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 3, 2019
• Study Start: January 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)