A Randomized, Double-Blind Phase 1/2 Study of INCB039110 in Combination With Erlotinib Versus Erlotinib Alone in patients with Non–Small Cell Lung Cancer Whose Tumors Have Epidermal Growth Factor Receptor–Activating Mutations

Phase 1

• Conditions: Male or female individuals, aged 18 years or older who have Stage IIIB/IV or recurrent NSCLC. Subjects must have tumors that are positive for EGFR-activating mutation, namely, exon 19 deletions, exon 21 L858R mutations, or point mutations at position 719. Enrolled subjects must have a life expectancy of at least 12 weeks and have adequate liver, kidney, and bone marrow function.; MedDRA version: 18.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 18.0 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001642-28-GB
• Lead Sponsor: Incyte Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 188

Inclusion Criteria

1. Men or women aged 18 years or older.
2. Histologically or cytologically confirmed diagnosis of nonsquamous NSCLC that is Stage IIIB, Stage IV, or recurrent (including prior Stage II).
3. Documented evidence of an activating mutation in EGFR in tumor samples (exon 19 deletions or point mutation L858R in exon 21 or point mutations at codon 719).
4. Radiographically measurable or evaluable disease.
5. Life expectancy of at least 12 weeks.
6. ECOG performance status of 0 to 2.
7. Negative serum pregnancy test at screening if female of childbearing potential
8. Male subjects must agree to take appropriate precautions to avoid fathering children
9. Ability to swallow and retain orally administered medications.
10. Ability to comprehend and willingness to sign an informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 88

Exclusion Criteria

1. Known presence of the T790M mutation in EGFR in tumor samples.
2. Candidates for curative radiation therapy or surgery.
3. Significant GI disorders with diarrhea as a major symptom
4. Distinct or suspected, or history of, pulmonary fibrosis or ILD.
5. Active central nervous system (CNS) metastases that require treatment or history of uncontrolled seizures.
6. Current or previous other malignancy within 2 years of randomization
7. Inadequate renal, hepatic, or bone marrow function demonstrated by Protocol-specified laboratory parameters at the screening visit.
8. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, and arrhythmia-requiring therapy.
9. Significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, GI, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
10. Concurrent therapy with a potent CYP3A4 inducer or inhibitor.
11. Chronic or current active infectious disease requiring systemic antibiotics, antifungals, or antivirals.
12. Known human immunodeficiency virus infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or at risk for HBV reactivation.
13. Pregnant or breastfeeding women.
14. Unwillingness to be transfused with blood components
15. Active alcohol or drug addiction that would interfere with the subject's ability to comply with the study requirements.
16. Known hypersensitivity to any of the active substances or any of their excipients, including INCB039110 and erlotinib.
17. Prior use of any JAK inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified