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Adjuvant Pembrolizumab in N2 Positive Non-small Cell Lung Cancer Patients

NCT03053856 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2017-02-15

No results posted yet for this study

Summary

This is a single arm, single center phase II study of adjuvant pembrolizumab in N2 positive non-small cell lung cancer (NSCLC) patients treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection. Patients will receive pembrolizumab 200 mg every 3 weeks for up to 24 months.

The primary objective of this study is to assess the efficacy of adjuvant pembrolizumab treatment in terms of disease-free survival (DFS; per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by the investigator).

The baseline assessment is part of the screening procedures and should be performed within 0 to 14 days before the start of study drug. The imaging modalities used for RECIST 1.1 assessment will be CT of chest or PET-CT if indicated. Follow-up chest CT for all patients will be assessed every 12 weeks for the first year, every 16 weeks for the second year, every 6 months for the third year, and every year thereafter. In subjects who discontinued study therapy without documented recurrence, every effort should be made to continue monitoring their disease status.

If an unscheduled assessment is performed, and the patient has not progressed, every attempt should be made to perform the subsequent assessments at their scheduled visits. RECIST 1.1 scans will be analyzed by the investigator on site; a central review will not be conducted.

Following completion or discontinuation of study drug, patients will enter a follow-up period.

Once a patient has had objective relapse recorded and has discontinued study drug, the patient will be followed for survival status every 3 months until death, withdrawal of consent or the end of the study.

Patients will also be requested to provide tumor samples from diagnostic (obtained before neoadjuvant CCRT) and surgical specimens for exploratory biomarker study. Sample provision is not optional, subject to a specific consent.

Conditions

  • Stage IIIA Non-small Cell Lung Cancer

Interventions

DRUG

Pembrolizumab

Adjuvant pembrolizumab 200 mg every 3 weeks for up to 24 months. (treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection)

PROCEDURE

Curative resection

Neoadjuvant concurrent chemoradiotherapy followed by curative resection

PROCEDURE

Neoadjuvant concurrent chemoradiotherapy

RT 44 Gy/22 Fractions for 5 weeks With Chemotherapy (Cisplatin 25mg/m2 once weekly, Paclitaxel 50mg/m2 once weekly)

DRUG

Cisplatin

25mg/m2 once weekly

DRUG

Paclitaxel

50mg/m2 once weekly

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-14
Primary Completion
2021-05-13
Completion
2021-08-13
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT03053856 on ClinicalTrials.gov