Mode
Text Size
Log in / Sign up
Phase 2 N=137 Randomized Treatment

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

Non-Small Cell Lung Cancer

Enrolled (actual)
137
Serious AEs
36.2%
Results posted
Jan 2017
Primary outcome: Primary: Progression-Free Survival (PFS) — 19.1; 19.0; 8.3 weeks — p=0.2133

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Olaratumab (Biological); Paclitaxel (Drug); Carboplatin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Aug 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-Free Survival (PFS)
19.1; 19.0; 8.3 0.2133
SECONDARY
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
66; 63; 10; 30; 21; 2
SECONDARY
Safety and Tolerability of Olaratumab Administered at a More Rapid Rate (25mg/Min With Minimum Infusion Time of 30 Minutes), Determined by Number of Participants With Treatment Related Adverse Events
66; 63; 10; 30; 21; 2
SECONDARY
Overall Survival (OS)
51.3; 50.1 0.8731
SECONDARY
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)
41.8; 34.4; 0 0.4721
SECONDARY
Median Duration of Response
14.4; 12.9
SECONDARY
Pharmacodynamics of Olaratumab
SECONDARY
Percentage of Participants With Anti-Olaratumab Antibodies
4.4; 0.0
SECONDARY
Pharmacokinetics (PK) - Area Under the Curve (AUC) 0-168 of Olaratumab
47600
SECONDARY
PK - Maximum Concentration (Cmax) of Olaratumab
489
SECONDARY
PK - Half-Life (t1/2) of Olaratumab
5.79
SECONDARY
PK - Clearance (Cl) of Olaratumab
0.0218
SECONDARY
PK - Steady State Volume of Distribution (Vss) of Olaratumab
4.22

Summary

The purpose of this study is to determine if participants with untreated locally advanced or metastatic non-small cell lung cancer have a better outcome when treated with olaratumab in combination with paclitaxel/carboplatin then when treated with paclitaxel/carboplatin alone.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 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
  • 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
  • The participant's Eastern Cooperative Oncology Group (ECOG) performance status is 0-1
  • The participant's age at the time of study entry is ≥ 18 years
  • 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
  • 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)
  • 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
  • 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
  • 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)
  • 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
  • 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.)
  • The participant has a life expectancy of ≥ 3 months
  • The participant has provided signed informed consent

Exclusion Criteria

  • 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
  • The participant has radiologically documented evidence of major b
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00918203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search