A Study of Paclitaxel/Carboplatin With or Without Olaratumab (IMC-3G3) in Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

The primary objective of this study is to evaluate the progression-free survival (PFS) in
previously untreated participants with Stage IIIB/IV non-small cell lung cancer (NSCLC)
treated with olaratumab plus paclitaxel and carboplatin versus paclitaxel and carboplatin in
the first-line metastatic setting.

Inclusion Criteria:

1. The participants has histologically or cytologically confirmed Non-Small Cell Lung
Cancer (NSCLC)Stage IIIB with effusion. Mixed Non-Small Cell Lung Cancer (NSCLC)
tumors will be categorized by the predominant cell type. Primary or metastatic site
may be used for histology

2. For squamous cell histology or for centrally located mediastinal masses (< 3 cm from
the carina) identified by computed tomography scan (CT) or chest x-ray, the
participant must undergo a magnetic resonance imaging (MRI) of the chest or I.V.
contrast CT scan within 3 weeks of randomization, to exclude major airway or blood
vessel invasion (in the investigator's opinion) by cancer

3. The participant has measurable disease (Tumors within a previously irradiated field
will be designated as "nontarget" lesions unless progression is documented or a biopsy
is obtained to confirm persistence at least 90 days following completion of radiation
therapy

4. The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0-1

5. The participant's age at the time of study entry is ≥ 18 years

6. The participant has adequate hematologic function as defined by an absolute neutrophil
count (ANC) ≥ 1500/μL, hemoglobin ≥ 9.5 g/dL, and a platelet count ≥ 100,000/μL
obtained within 2 weeks prior to randomization

7. The participant has adequate hepatic function as defined by a total bilirubin ≤ 1.5
mg/dL, and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 × the
upper limit of normal (ULN), or ≤ 5 × the ULN in the presence of known liver
metastases)

8. The participant has adequate renal function as defined by serum creatinine ≤ 1.5 × the
institutional ULN. If creatinine is above the ULN, the patient's creatinine clearance
(CrCl) is ≥ 60 mL/min

9. The participant has urinary protein ≤ 1+ on dipstick or routine urinalysis; if urine
dipstick or routine analysis is ≥ 2+, a 24-hour urine for protein must demonstrate < 1
g of protein in 24 hours to allow participation

10. The participant has adequate coagulation function, as defined by international
normalized ratio (INR) ≤ 1.5 and a partial thromboplastin time (PTT) ≤ 5 seconds above
ULN if not receiving anticoagulation therapy. Participants on full-dose
anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight
heparin, have therapeutic INR, no active bleeding (defined as within 14 days
randomization) and no pathological condition that carries a high risk of bleeding (eg,
tumor involving major vessels or known varices)

11. Because the teratogenicity of Olaratumab is not known, women of childbearing potential
(WOCBP) and sexually active males must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to randomization and for the
duration of study participation

12. The participant has resolution to Grade ≤ 1 by the National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 4 (NCI-CTCAE v 4.02) of all
clinically significant toxic effects of prior locoregional therapy, surgery,
chemoembolization, or other anticancer therapy. The exceptions for such effects are
events that pertain to the lab values found elsewhere in these inclusion criteria.
(For example, criterion # 6 states that a patient with hemoglobin ≥ 9.5 g/dL is
considered eligible, even though NCI-CTCAE v 4.02 defines this value as Grade 2
anemia.)

13. The participant has a life expectancy of ≥ 3 months

14. The participant has provided signed informed consent

Exclusion Criteria:

1. The participant has untreated central nervous system (CNS) metastases. Participants
are eligible if they are clinically stable, off all steroids after cranial irradiation
(whole brain radiation therapy, focal radiation therapy, stereotactic
radiosurgery)ending at least 2 weeks prior to randomization, or after surgical
resection performed at least 4 weeks prior to randomization

2. The participant has radiologically documented evidence of major blood vessel invasion
or encasement by cancer, or of intratumor cavitation

3. The participant received prior systemic chemotherapy or biologic therapy (eg
erlotinib) for Stage IIIB/IV NSCLC outside of the adjuvant setting. Participants who
received prior cytotoxic chemotherapy or biologic therapy in the adjuvant setting will
not be excluded based on such therapy

4. The participant has a history of another primary cancer, with the exception of a)
curatively resected nonmelanomatous skin cancer b) curatively treated cervical
carcinoma in situ c)other primary solid tumor treated with curative intent, no known
active disease present, and no treatment administered during the last 3 years prior to
randomization

5. The participant is receiving concurrent treatment with other anticancer therapy,
including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy,
chemo-embolization, targeted therapy, or an investigational agent

6. The participant has an uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection requiring parenteral antibiotics, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements

7. The participant has an uncontrolled thrombotic or hemorrhagic disorder

8. The participant has a history of gross hemoptysis (defined as bright red blood or ≥
1/2 teaspoon) within 2 months of randomization

9. The participant has a serious non-healing wound, ulcer, or bone fracture within 28
days prior to randomization

10. The participant has undergone major surgery within 28 days prior to randomization

11. The participant has received adjuvant chemotherapy 21 days prior to randomization or
has participated in clinical trials of experimental agents within 28 days prior to
randomization

12. The participant has an elective or a planned major surgery to be performed during the
course of the trial

13. The participant has peripheral neuropathy ≥ Grade 2 NCI-CTCAE v 4.02

14. The participant has known human immunodeficiency virus (HIV) positivity

15. The participant, if female, is pregnant or lactating

16. The participant has received previous therapy with any agent that targets platelet
derived growth factor (PDGF) or platelet derived growth factor receptor (PDGFR)

17. The participant has a known allergy to any of the treatment components

18. The participant has a history of allergic reactions attributed to compounds of
chemical or biologic composition similar to that of Olaratumab