Pembrolizumab for Non-Small-Cell Lung Carcinoma

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Non-Small-Cell Lung Carcinoma+1 MorePembrolizumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the efficacy of three different treatments for unresectable, locally advanced NSCLC. Arm 1 will receive pembrolizumab concurrently with chemoradiation, followed by pembrolizumab with olaparib placebo. Arm 2 will receive the same treatment as Arm 1, but will take olaparib instead of the placebo. Arm 3 will receive concurrent chemoradiation therapy followed by durvalumab. The primary hypothesis is that pembrolizumab with concurrent chemoradiation and olaparib is superior to durvalumab with respect to PFS and OS.

Eligible Conditions
  • Non-Small-Cell Lung Carcinoma
  • Lung Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 16 Secondary · Reporting Duration: Up to approximately 72 months

Month 72
Change From Baseline in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
Change From Baseline in Cough Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module 13 (EORTC QLQ-LC13) Item 1 Score
Change From Baseline in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
Change from Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Scale Score
Change from Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
Month 48
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Month 72
Discontinuation Rate of Study Intervention Due to an Adverse Event (AE)
Duration of Response (DOR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Incidence of Adverse Events (AE)
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Overall Survival (OS)
Month 72
TTD in Chest Pain Using the EORTC QLQ-LC13 Item 10 Score
TTD in Cough Using the EORTC QLQ-LC13 Item 1 Score
TTD in Dyspnea Using the EORTC QLQ-C30 Item 8 Score
TTD in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
TTD in Role Functioning Using the EORTC QLQ-C30 Items 6-7 Score
Time to Deterioration (TTD) in HRQoL Using the EORTC QLQ-C30 Items 29 and 30 Score

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

3 Treatment Groups

chemoradiation→durvalumab
1 of 3
pembrolizumab+chemoradiation→pembrolizumab+olaparib
1 of 3
pembrolizumab+chemoradiation→pembrolizumab+olaparib placebo
1 of 3

Active Control

Experimental Treatment

870 Total Participants · 3 Treatment Groups

Primary Treatment: Pembrolizumab · Has Placebo Group · Phase 3

pembrolizumab+chemoradiation→pembrolizumab+olaparibExperimental Group · 8 Interventions: Olaparib, Paclitaxel, Pembrolizumab, Pemetrexed, Thoracic Radiotherapy, Etoposide, Cisplatin, Carboplatin · Intervention Types: Drug, Drug, Biological, Drug, Radiation, Drug, Drug, Drug
pembrolizumab+chemoradiation→pembrolizumab+olaparib placeboExperimental Group · 8 Interventions: Paclitaxel, Pembrolizumab, Pemetrexed, Thoracic Radiotherapy, Placebo for olaparib, Etoposide, Cisplatin, Carboplatin · Intervention Types: Drug, Biological, Drug, Radiation, Drug, Drug, Drug, Drug
chemoradiation→durvalumabActiveComparator Group · 7 Interventions: Paclitaxel, Pemetrexed, Thoracic Radiotherapy, Durvalumab, Etoposide, Cisplatin, Carboplatin · Intervention Types: Drug, Drug, Radiation, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved
Paclitaxel
FDA approved
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Thoracic Radiotherapy
2003
Completed Phase 2
~110
Etoposide
FDA approved
Cisplatin
FDA approved
Carboplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 72 months

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,577,489 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,673 Previous Clinical Trials
4,958,034 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,635 Previous Clinical Trials
7,940,357 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have not received prior treatment (chemotherapy, targeted therapy or radiotherapy) for Stage III NSCLC; participants who have received neoadjuvant and/or adjuvant therapy for early stage disease are not eligible.
You have pathologically (histologically or cytologically) confirmed diagnosis of NSCLC.
You are unable to undergo surgery with curative intent for Stage III NSCLC.
You have no evidence of metastatic disease indicating Stage IV NSCLC.
You have provided a tumor tissue sample (tissue biopsy [core, incisional, or excisional]).
You have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 assessed within 7 days prior to the first administration of study intervention.
You have a life expectancy of at least 6 months.

Who else is applying?

What state do they live in?
Maryland100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Fox Chase Cancer Center ( Site 0063)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%