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

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.

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.