An Open-label Phase Ib/II Study of BAY 1000394 (Roniciclib) in Combination With Docetaxel in Second- or Third-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

Screening must be performed within 14 days prior to the first dose of study drug. Subjects are eligible for inclusion in this study if all of the following criteria are met:

Histologically or cytologically confirmed stage IIIB or IV NSCLC Patients who received prior 1 or 2 lines of systemic anticancer therapy. For EGFR mutated or ALK rearranged patients, EGFR TKI or ALK inhibitor is also considered a line of systemic therapy

Documented progressive disease after platinum-containing doublet chemotherapy (Platinum-containing chemotherapy given as an neoadjuvant/adjuvant chemotherapy, or definitive concurrent chemoradiotherapy within 6 months can be considered as one line of chemotherapy)

For patients who showed non-progressive disease with 1st line platinum-doublet chemotherapy, continuation maintenance therapy is not considered a line of therapy, whereas switch maintenance therapy is considered another line of therapy.

EGFR mutated or ALK rearranged patients can be eligible after one line of EGFR TKI or ALK inhibitor and platinum-doublet chemotherapy.

Any prior systemic anticancer therapy must have been completed at least 3 weeks prior to initiation of study medication. Palliative radiation, whole brain radiotherapy (WBRT), or gamma knife surgery (GKS) for brain metastases must have been completed at least 2 weeks prior to initiation of study medication. Major or minor surgery must have been completed at least 4 or 2 weeks prior to initiation of study medication, respectively. Majority or minority of surgery can be decided at the investigator's discretion. Any acute toxicity must have recovered to Grade ≤ 1 (except alopecia).

Male or female subjects aged ≥18 years

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 14 days prior to the first dose of study drug:

At least one measurable lesion based on RECIST 1.1

Availability of tumor tissue for molecular analysis is not mandatory (presence of archival tissue or re-biopsy for acquisition of tumor tissue is strongly recommended)

History of organ allograft

Evidence or history of bleeding disorder, ie any hemorrhage / bleeding event of NCI-CTCAE v4.0 \>Grade 2 within 4 weeks prior to the first dose of study treatment

Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management)

Serious, non-healing wound, ulcer, or bone fracture (bone fractures due to bone metastases are acceptable)

What this study is about