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Phase 2 N=280 Randomized Treatment

A Study of Pemetrexed and Carboplatin/Cisplatin or Gemcitabine and Carboplatin/Cisplatin With or Without IMC-1121B in Participants Previously Untreated With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)

Carcinoma, Non-Small-Cell Lung

Enrolled (actual)
280
Serious AEs
55.6%
Results posted
Dec 2014
Primary outcome: Primary: Progression-Free Survival (PFS) — 5.6; 7.2; 5.4; 5.6 months — p=0.1318

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
IMC-1121B (ramucirumab) (Biological); Pemetrexed (Drug); Carboplatin (AUC 6) (Drug); Cisplatin (Drug); Gemcitabine (Drug); Carboplatin (AUC 5) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Jan 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Progression-Free Survival (PFS)
5.6; 7.2; 5.4; 5.6 0.1318
SECONDARY
Percentage of Participants With Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
38.0; 49.3; 24.6; 46.5 0.1797
SECONDARY
Overall Survival (OS)
10.4; 13.9; 11.3; 10.4 0.8916
SECONDARY
Duration of Response (DOR)
4.5; 5.5; 4.3; 4.3
SECONDARY
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Who Died
38; 44; 29; 39; 68; 67

Summary

The purpose of this study is to determine if participants with Stage IV NSCLC have a better outcome when treated with IMC-1121B in combination with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin than when treated with pemetrexed + carboplatin/cisplatin or gemcitabine + carboplatin/cisplatin alone.

Eligibility Criteria

Inclusion Criteria

  • Confirmed NSCLC
  • Stage IV disease at the time of study entry
  • Measurable disease at the time of study entry
  • Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopecia)
  • Adequate hematologic function, hepatic function, renal function and coagulation function
  • If sexually active, must be post-menopausal, surgically sterile, or using effective contraception; and agrees to use adequate contraception during the study period and for up to 6 months after the last dose of study medication
  • Female participants of childbearing potential must have a negative serum pregnancy test

Exclusion Criteria

  • Has cirrhosis at a level of Child-Pugh B (or worse), or cirrhosis and a history of hepatic encephalopathy, or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
  • Tumor wholly or partially contains small cell lung cancer
  • Untreated central nervous system (CNS) metastases, eligible if they are clinically stable with regard to neurologic function, off all steroids after cranial irradiation at least 2 weeks prior or after surgical resection performed at least 4 weeks prior to randomization
  • Concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix. A participant with previous history of malignancy other than NSCLC is eligible, provided that he/she has been free of disease for ≥ 3 years
  • Received prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor (VEGFR)
  • Receiving concurrent treatment with other anticancer therapy
  • Has received previous chemotherapy for Stage IV NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization)
  • Has radiologically documented evidence of major blood vessel invasion or encasement by cancer
  • Has undergone chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions)
  • Ongoing or active infection
  • History of significant neurological or psychiatric disorders
  • Experienced clinically relevant coronary artery disease, myocardial infarction within 6 months prior to randomization, uncontrolled congestive heart failure, or symptomatic poorly controlled arrhythmia
  • Poorly-controlled hypertension
  • Experienced any serious Grade 3-4 gastrointestinal bleeding within 3 months prior to study entry
  • Receiving chronic daily treatment with aspirin (> 325 mg/day) or other known inhibitors of platelet function
  • Serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
  • Major surgery within 28 days prior the first dose of study medication, or subcutaneous venous access device placement within 7 days prior to randomization
  • Elective or a planned major surgery
  • Pregnant or lactating
  • Any other serious uncontrolled medical disorders or psychological conditions
  • Allergy / history of hypersensitivity reaction to any of the treatment components
  • History of drug abuse
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01160744). 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.

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