Study of INCB039110 in Combination With Docetaxel in Subjects With Non-Small Cell Lung Cancer

Incyte

Status and phase: Terminated; Phase 2

Conditions: NSCLC (Non-small Cell Lung Carcinoma)

Treatments: Drug: docetaxel; Drug: Itacitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02257619

INCB 39110-203

Details and patient eligibility

About

The primary objectives of this study is to evaluate the safety and tolerability of itacitinib in combination with docetaxel and to select doses for further evaluation (Part 1, safety run-in portion).

Full description

Sponsor decision to not initiate part 2 of the trial and Part 2 of the study was not conducted.

In Part 2, the randomized portion, the objective is to evaluate and compare the overall survival of subjects with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) when treated with itacitinib in combination with docetaxel versus docetaxel alone.

The secondary objectives of this study (Part 2) are to evaluate and compare the efficacy of the 2 treatment groups with respect to progression-free survival, overall tumor response, and duration of response, and to evaluate and compare disease control, safety, and tolerability of itacitinib in combination with docetaxel versus docetaxel alone.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed diagnosis of NSCLC that is Stage IIIb, IV, or recurrent.
2. Received only 1 prior systemic chemotherapy regimen for Stage IIIb, IV, or recurrent disease not including neoadjuvant and/or adjuvant therapy. (NOTE: Exceptions may be allowed based on prior treatment regimens and tumor types in agreement with protocol requirements.)
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
4. Life expectancy of ≥12 weeks.

Exclusion criteria

1. Received prior treatment with docetaxel.

2. Known active central nervous system (CNS) metastases. Subjects with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to study entry, defined as:

   1. No evidence of new or enlarging CNS metastasis or new neurological symptoms attributable to CNS metastases.
   2. Subjects who are receiving concomitant corticosteroids must be on a stable or decreasing dose for at least 4 weeks prior to first dose of study treatment and off all anticonvulsants for at least 4 weeks prior to study entry.

3. Peripheral neuropathy ≥ Grade 3.

4. 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.

5. Significant, concurrent, uncontrolled medical condition including but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.

6. Unwilling to be transfused with blood components.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

9 participants in 1 patient group

Itacitinib plus docetaxel

Experimental group

Treatment:

Drug: docetaxel

Drug: Itacitinib