NCT03041181

Single Agent Chemotherapy +/- Nivolumab in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor

Randomized Phase II Trial of Single Agent Chemotherapy Plus Nivolumab or Single Agent Chemotherapy Alone in Patients With Advanced Squamous or Non-squamous NSCLC With Primary Resistance to Prior PD-1 or PDL-1 Inhibitor

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Nasser Hanna, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized phase II study assessing the activity of single agent chemotherapy combined with nivolumab (Arm A) compared to single agent chemotherapy alone (Arm B) in squamous or non-squamous NSCLC subjects with primary resistance to prior PD-1 or PDL-1 inhibitor. The single agent chemotherapy chosen is at the discretion of the site investigator and may include pemetrexed, gemcitabine or taxotere. Institutional standards should be used for administration of the single agent chemotherapy. For both treatment arms, 21 days equals 1 cycle of therapy and subjects will be eligible to continue treatment until progressive disease by RECIST v1.1 or unacceptable toxicity. Upon registration, subjects will be randomized in a 1:1 ratio to either treatment with single agent chemotherapy or single agent chemotherapy in combination with nivolumab. Randomization is un-blinded and open-label; therefore there will be no placebo treatment for subjects randomized to single agent chemotherapy

Conditions

• Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
• Adenocarcinoma of the Lung
• Lung Cancer
• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
DRUG	Nivolumab	Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)
DRUG	Gemcitabine	Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)
DRUG	Pemetrexed	Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)

Timeline

• Start date: 2017-01-27
• Primary completion: 2019-05-23
• Completion: 2019-05-23
• First posted: 2017-02-02
• Last updated: 2022-07-11
• Results posted: 2019-11-29

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study