MedTrace Logo

Anti PD-1 Neo-adjuvant Treatment for NSCLC

NCT02938624 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-12-14

No results posted yet for this study

Summary

A single arm, phase I, dose escalation trial and expansion cohort, examining the safety and feasibility of neoadjuvant pembrolizumab treatment for early resectable NSCLC patients.

Hypothesis: The investigators hypothesize that response rate to neo-adjuvant pembrolizumab will be higher than the response rate of advanced NSCLC patients.

Conditions

  • Non Small Cell Lung Carcinoma
  • Stage I
  • Stage II

Interventions

DRUG

Pembrolizumab 200 mg IV single dose

Pembrolizumab 200 mg IV single dose, 21 days later surgery

DRUG

Pembrolizumab 200 mg IV twice interval 21 days

Pembrolizumab 200 mg IV twice interval 21 days, 21 days later surgery

DRUG

Pembrolizumab 200 mg IV Twice interval 21d,surgery after 10d

Pembrolizumab 200 mg IV Twice interval 21d,surgery after 10d

DRUG

Pembrolizumab 100 mg I.V single dose

Pembrolizumab 100 mg I.V single dose, surgery after 21 days.

PROCEDURE

Surgical resection of tumor

Surgical resection of tumor by any of the acceptable procedures

Sponsors & Collaborators

Principal Investigators

  • Sheba Medical Centre Jair, MD PHD · Chaim Sheba Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-07
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Companies

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 NCT02938624 on ClinicalTrials.gov