Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)

The study was intended to be a phase I/II trial, but the study never moved forward to Phase
II due to recruitment challenges.

Inclusion Criteria:

To be eligible for the study (Phase Ib and Phase II) the subject must fulfill all of the
following criteria:

- Male or female subjects at least 18 years of age

- Histological or cytological diagnosis of SCLC

- Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include
malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany,
M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that
precludes a tolerable radiation field, as judged by the Investigator])

- Subjects eligible for first line platinum-based chemotherapy

- Measurable or evaluable disease according to RECIST v1.1

- Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to
(<=) 2

- Life expectancy of greater than equals to (≥) 3 months

- Female subjects of childbearing potential and male subjects with female partners of
childbearing potential must be willing to avoid pregnancy Note: Other protocol defined
criteria could apply.

Exclusion Criteria:

Subjects are not eligible for the study if they fulfill any of the following exclusion
criteria:

- Prior anticancer therapy for extensive disease (ED) SCLC including experimental
agents.

- Concurrent use of other anticancer therapy including any investigational agent within
28 days prior to the first dose of the investigational drug M3814.

- Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by
Investigator judgment)

- Prior bone marrow/stem cell transplantation within 5 years before study start (Phase
II only)

- Major surgical intervention within 28 days prior to the first dose of investigational
drug administration. Intervention(s) to establish the diagnosis for SCLC is permitted
within 28 days as long as subjects are cleared by the medical and surgical teams.

- Poor vital organ functions defined as:

- Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deci
liter (g/dL) (5.7 micromole per liter (μmol/L)), absolute neutrophil count < 1.5 ×
109/L, platelets < 100 × 109/L

- Renal impairment as evidenced by calculated creatinine clearance < 60 mL/minutes (min)
(according to the Cockcroft-Gault formula)

- Liver function abnormality as defined by total bilirubin greater than (>) 1.5 × upper
limit of normal (ULN) or aspartate aminotransferase (AST)/alanine aminotransferase
(ALT) > 2.5 × ULN (subjects with liver involvement: a maximum of AST/ALT 5 × ULN)

- Contraindication to the use of etoposide or cisplatin

- Subjects currently receiving (or unable to stop using prior to receiving the first
dose of investigational drug) medications or herbal supplements known to be potent
inhibitors of cytochrome P450 (CYP) 3A and CYP2C19 (unless treatment can be
discontinued at least 1 week prior to receiving the first dose of investigational
drug) or potent inducers of CYP3A and CYP2C19 (unless treatment can be discontinued at
least 3 weeks prior to receiving the first dose of investigational drug). Note: Other
protocol defined criteria could apply.