Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

a JAK 1 selective small molecule inhibitor

Itacitinib

a highly selective humanized monoclonal antibody (mAb)

Corey Langer, MD

This is a single center, single arm phase 2 study to establish the safety and efficacy of itacitinib (also known as INCB039110) administered in combination with pembrolizumab in patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC).

Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer

Phase II Study of Pembrolizumab and Itacitinib (INCB039110) for First Line Treatment of Metastatic Non-Small Cell Lung Cancer Expressing PD-L1

Responses will be compared subject's baseline assessment and historical controls using pembrolizumab monotherapy.

Number of subjects treated with the combination.

Number of participants who remained progression free at week 12

Number of subjects treated with pembrolizumab and itacitinib that survived to week 16.

University of Pennsylvania

Itacitinib: a JAK 1 selective small molecule inhibitor

Pembrolizumab: a highly selective humanized monoclonal antibody (mAb)

Itacitinib and Pembrolizumab

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

Regulatory Lead

Of the 23 subjects enrolled, 2 subjects were not included in analysis because they did not receive Itacitinib due to pembrolizumab toxicity or subject withdrawal.

Number of Subjects With a Response at 12 Weeks According to RECIST 1.1 for the Combination of Pembrolizumab and Itacitinib Among Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC.

Of the 23 subjects enrolled, 3 subjects were not included in analysis because they only received pembrolizumab and not itacitinib.

Number of Subjects With Toxicities (CTCAE v5.0 Scoring) of Pembrolizumab and Itacitinib in Patients With Previously Untreated, PD-L1 Positive Metastatic NSCLC

Number of Participants Who Had a Progression Free Survival (PFS) Treated With Pembrolizumab and Itacitinib.

Of the 23 subjects enrolled, 2 subjects were not included in analysis because they did not receive Itacitinib.

Number of Participants Treated With Pembrolizumab and Itacitinib, Who Had a Minimum Duration of Response (DOR) of 12 Weeks.

Overall Survival (OS) for Subjects Treated With Pembrolizumab and Itacitinib.

Dose and Route of Administration

* Itacitinib: 200mg PO (extended release formulation)
* Pembrolizumab: 200mg IV infusion over 30 minutes Regimen
* Treatment = 3 week (Q3W) dosing cycles
* Itacitinib: Once daily for Cycle 3 and Cycle 4 (up to 6 weeks)
* Pembrolizumab: Q3 week cycles of treatment beginning at Day 1

Spots Global Cancer Trial Database for Pembrolizumab and Itacitinib (INCB039110) for Non-Small Cell Lung Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial