An Open-Label Phase 1/2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

NCT02917993 | Completed Phase 1

• 2 other identifiers: INCB 39110-2072017-001750-34
• Study Type: interventional
• Target: 59
• Locations: 4 countries
• Sites: 31

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of itacitinib in combination with osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; locally advanced; metastatic; epidermal growth factor receptor (EGFR) inhibition; Janus kinase inhibition

Outcome Measures

Primary Outcomes (3)

• Phase 1: Frequency, severity, and duration of adverse events (AEs)

  From screening through 30-35 days after end of treatment, approximately 2 years.

• Phase 1: Number of subjects with dose-limiting toxicities (DLTs)

  Day 1 through Day 28

• Phase 2: Objective response rate (ORR) based on RECIST v1.1

  ORR defined as the percentage of subjects who have a confirmed best overall response of complete response (CR) or partial response (PR).

  Screening and 8-week intervals throughout the study, approximately 2 years.

Secondary Outcomes (6)

• Phase 1 and Phase 2: Maximum plasma concentration (Cmax) of itacitinib and osimertinib when administered in combination

  Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

• Phase 1 and Phase 2: Area under the plasma concentration-time curve (AUC) of Itacitinib and osimertinib when administered in combination

  Measured at protocol-defined study visits from Cycle 1 Day 1 through Cycle 1 Day 28.

• Phase 2: Depth of response (DpR) based on RECIST v1.1

  Screening and 8-week intervals throughout the study, approximately 2 years.

• Phase 2: Progression-free survival (PFS)

  Interval from the first day of study treatment until disease progression or death due to any cause, approximately 3 years.

• Phase 2: Overall survival (OS)

  Interval from the first day of study treatment until death due to any cause, approximately 3 years.

Study Arms (1)

Itacitinib + osimertinib

EXPERIMENTAL

Drug: Itacitinib; Drug: Osimertinib

Interventions

Itacitinib DRUG

In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.

Also known as: INCB039110

Itacitinib + osimertinib

Osimertinib DRUG

Osimertinib 80 mg once daily (QD)

Itacitinib + osimertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older at screening; outside the U.S. and European Union, an older limit could apply depending on local regulation (eg, 19 years and older for South Korea and 20 years and older for Taiwan).
• Histologically or cytologically confirmed unresectable locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC.
• Documented evidence of somatic activating mutation in EGFR (eg, G719X, exon 19 deletion, L858R, L861Q) in a tumor tissue sample. If a tissue sample is not available, then EGFR mutation status may be determined from circulating tumor DNA obtained from a blood sample using a validated or approved test kit.
• Phase 1: Subjects must have previously received and progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI). Additional lines of systemic therapy including investigational agents for locally advanced or metastatic NSCLC are allowed.
• Phase 2: Subjects must not have received more than 1 prior line of therapy for locally advanced or metastatic NSCLC. First-line treatment must include an EGFR TKI, and subjects must have documented disease progression during or following treatment. Subjects with disease that progressed more than 6 months after completion of neoadjuvant/adjuvant chemotherapy or chemoradiation therapy are eligible if they received an EGFR TKI as first-line treatment for advanced NSCLC.
• Subjects must have evidence of a T790M mutation in tumor tissue or plasma obtained after disease progression during or after treatment with an EGFR TKI. T790M mutation status from a local laboratory is acceptable; however, a tumor tissue sample or plasma sample suitable for centralized T790M mutation analysis must be available.
• Radiographically measurable or evaluable disease per RECIST v1.1.

You may not qualify if:

• Known CNS metastases, unless stable and asymptomatic. Subjects with CNS metastases may be eligible for the study, provided:
• There is no evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
• Subjects who are receiving corticosteroids must be on a stable or decreasing dose for at least 4 weeks before first dose of study treatment.
• Laboratory parameters outside the protocol-defined range.
• Clinically significant abnormalities found on an ECG.
• Clinically significant or uncontrolled cardiac disease.
• Past history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
• Current or previous other malignancy within 2 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive malignancy.
• Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or hormonal therapy).
• Any previous use of Janus kinase (JAK) inhibitor, osimertinib, or other EGFR-directed therapy for T790M-mt NSCLC.

Sponsors & Collaborators

• Incyte Corporation: lead
• AstraZeneca: collaborator

Study Sites (31)

University of California San Diego, 3855 Health Sciences Drive, Mc 0987

La Jolla, California, 92093, United States

Location

University California San Francisco Thoracic Surgery and Oncology Clinic, 1600 Divisadero Street, Floor 4

San Francisco, California, 94115, United States

Location

Innovative Clinical Research Institute, 15111 Whittier Blvd., Suite 216

Whittier, California, 90603, United States

Location

Rocky Mountain Cancer Center, 1800 Williams Street, Suite 200

Denver, Colorado, 80124, United States

Location

Georgetown University Hospital, 3800 Reservoir Rd, NW

Washington D.C., District of Columbia, 20007, United States

Location

Lynn Cancer Center, 701 NW 13th Street, Floor 2

Boca Raton, Florida, 33486, United States

Location

Dana-Farber Cancer Institute, 450 Brookline Avenue

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System, 2799 W Grand Blvd.

Detroit, Michigan, 48202, United States

Location

Karmanos Cancer Institute, 4100 John R. street mail Code HW04HO

Detroit, Michigan, 48202, United States

Location

Valley Hospital, 223 N Van Dien Avenue

Ridgewood, New Jersey, 07450, United States

Location

NYU Langone Medical Center, 160 East 34th Street, Floor 8

New York, New York, 10016, United States

Location

Stony Brook University Medical Center, 3 Edmund D. Pellegrino Road

Stony Brook, New York, 11794, United States

Location

Cleveland Clinic, 9500 Euclid Avenue, G Building

Cleveland, Ohio, 44195, United States

Location

Earle A. Chiles Research Institute Providence Cancer Center, 4805 NE Glisan Street, 2N35

Portland, Oregon, 97213, United States

Location

St. Luke's University Health Network, 701 Ostrum Street, Suite 403

Fountain Hill, Pennsylvania, 18015, United States

Location

Thomas Jefferson University, 111 S. 11th Street

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Oncology - South Austin, 901 West 38th Street, Suite 200

Austin, Texas, 78705, United States

Location

University of Texas -MD Anderson Cancer Center, 1515 Holcombe Blvd.

Houston, Texas, 77030, United States

Location

Texas Oncology - San Antonio Medical, 5206 Research Drive

San Antonio, Texas, 78240, United States

Location

Texas Oncology-Tyler, 910 E Houston Street, Suite 100

Tyler, Texas, 75702, United States

Location

Huntsman Cancer Institute, 2000 Circle of Hope Drive

Salt Lake City, Utah, 84112, United States

Location

US Oncology-Virginia Cancer Specialists, PC, 8503 Arlington Blvd., Suite 400

Fairfax, Virginia, 22031, United States

Location

West Virginia University Cancer Institute, 1 Medical Center Drive

Morgantown, West Virginia, 26506, United States

Location

The catholic University of Korea, Seoul St. Mary's hospital, 222 Banpo-daero

Seoul, Seocho-gu, 06591, South Korea

Location

Severance Hospital, Yonsei University Health System 50-1 Yonsei-ro

Seoul, Seodaemun-gu, 03722, South Korea

Location

Asan Medical Center Department of Oncology, 88, Olympic-ro 43-gil

Seoul, Songpa-gu, 05505, South Korea

Location

Antiga Guarderia-Servei d'Oncologia Hospital Vall d'Hebron. P.Vall Hebron 119-129

Barcelona, 08035, Spain

Location

Hospital Ramón y Cajal Ctra. Colmenar Viejo Km. 9,1 Planta (-)2 Dcha Oficina de Ensayos Clínicos Servicio de Oncología Médica

Madrid, 28034, Spain

Location

Hospital Clinico Universitario Valencia Avenida Blasco Ibáñez 17 -8º

Valencia, 46010, Spain

Location

Taipei Veterans General Hospital, No.201 Sec. 2 Shipai Rd l

Taipei, Beitou District, 11217, Taiwan

Location

National Taiwan University Hospital, 7 Zhongshan South Road

Taipei, Zhongzheng District, 10002, Taiwan

Location

Related Links

• An Open-Label Phase 1/ 2 Study of Itacitinib in Combination With Osimertinib in Subjects With Non-Small Cell Lung Cancer

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Inhibition, Psychological

Interventions

itacitinib; INCB039110; osimertinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Peter Langmuir

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: September 28, 2016
• Study Start: December 20, 2016
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

KR (3); ES (3); US (23); TW (2)