Trial Purpose

The purpose of this study is to assess the efficacy and safety of pembrolizumab in combination with concurrent chemoradiation therapy followed by either pembrolizumab with olaparib placebo (Arm 1) or with olaparib (Arm 2) compared to concurrent chemoradiation therapy followed by durvalumab (Arm 3) in participants with unresectable, locally advanced NSCLC. Arms 1 and 2 will be studied in a double-blind design and Arm 3 will be open-label. The primary hypotheses are:

Pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab with olaparib is superior to concurrent chemoradiation therapy followed by durvalumab with respect to progression-free survival (PFS) and overall survival (OS)
pembrolizumab with concurrent chemoradiation therapy followed by pembrolizumab is superior to concurrent chemoradiation therapy followed by durvalumab with respect to PFS and OS

Learn More on ClinicalTrials.gov

CLINICALTRIALS.GOV IDENTIFIER:

NCT04380636

When speaking to your doctor, please have the trial identifier number available.

About The Study

All patients who enroll in the trial will receive medication while on the study.

33% of participants will receive chemotherapy* and radiotherapy followed by pembrolizumab and olaparib placebo

33% of participants will receive chemotherapy* and radiotherapy followed by pembrolizumab and olaparib

33% of participants will receive chemotherapy* and radiotherapy followed by durvalumab

*Your doctor will decide which chemotherapy treatment is best for you.

Trial Phase Icon

Phase 3

Tests the medicine or vaccine in large groups of trial participants (from several hundred to several thousand). For medicines, volunteers have the disease or condition the medicine is designed to treat. In vaccine studies, the volunteers may be healthy or have diseases or conditions. Phase 3 trials take place in hospitals, clinics, or physician offices.

Trial start Icon

Dates

  • Actual study start date 6 July 2020
  • Estimated primary completion date 6 July 2026
  • Estimated study completion date 6 July 2026

Eligibility

Only a qualified healthcare professional can determine your eligibility. However, this information may be useful in starting a conversation with your doctor.

Conditions Icon

Conditions

Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

Age Range Icon

Age Range

18 - No Age Maximum

Sex Icon

Sex

All

Trial locations

Locations provided may not reflect the most current site information. Please call the number provided in the location results to confirm.