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A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01185847
Recruitment Status : Completed
First Posted : August 20, 2010
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE August 19, 2010
First Posted Date  ICMJE August 20, 2010
Last Update Posted Date January 1, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • Part 2: Progression-free survival, according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  • Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
  • Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) [ Time Frame: 6 months ]
  • Part 2: Progression-free survival, according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2014)
  • Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed [ Time Frame: multiple sampling cycles 1-6 (18 weeks) ]
  • Duration of response, according to RECIST criteria by CT/MRI [ Time Frame: from response to disease progression ]
  • Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  • Overall survival [ Time Frame: 23 months ]
  • Overall response rate (ORR), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2010)
  • Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed [ Time Frame: multiple sampling cycles 1-6 (18 weeks) ]
  • Overall response rate (ORR), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  • Duration of response, according to RECIST criteria by CT/MRI [ Time Frame: from response to disease progression ]
  • Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  • Overall survival [ Time Frame: 23 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
Official Title  ICMJE A Randomized, Multicenter, Open-label Phase Ib/II Study of RO5083945 in Combination With Cisplatin and Gemcitabine/Pemetrexed Versus Cisplatin and Gemcitabine/Pemetrexed in Patients With Advanced or Recurrent Non Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy
Brief Summary This open label, 2-part study will evaluate the safety and efficacy of RO5083945 in combination with standard chemotherapy in patients with advanced or recurrent non-small cell lung cancer who have not received prior chemotherapy. In Part 1 patients will receive RO5083945 intravenously and standard chemotherapy (cisplatin plus either gemcitabine or pemetrexed) for up to 6 cycles of 3 weeks and then RO5083945 until disease progression. In Part 2 patients will be randomized to receive either RO5083945 in combination with standard chemotherapy or chemotherapy alone for up to 6 cycles. In the absence of disease progression, patients receiving RO503945 can continue treatment with RO5083945 as monotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Squamous Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: RO5083945
    intravenously, until disease progression
  • Drug: cisplatin
    standard treatment, up to 6 cycles
  • Drug: gemcitabine
    standard treatment, up to 6 cycles
  • Drug: pemetrexed
    standard treatment, up to 6 cycles
Study Arms  ICMJE
  • Experimental: A non-squamous
    Interventions:
    • Drug: RO5083945
    • Drug: cisplatin
    • Drug: pemetrexed
  • Experimental: A squamous
    Interventions:
    • Drug: RO5083945
    • Drug: cisplatin
    • Drug: gemcitabine
  • Active Comparator: B non-squamous
    Interventions:
    • Drug: cisplatin
    • Drug: pemetrexed
  • Active Comparator: B squamous
    Interventions:
    • Drug: cisplatin
    • Drug: gemcitabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2012)
90
Original Estimated Enrollment  ICMJE
 (submitted: August 19, 2010)
160
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Advanced (IIIb), metastatic (IV) or recurrent non-small cell lung cancer
  • At least 1 measurable disease lesion as per RECIST criteria
  • Confirmed presence of EGFR in tumor tissue
  • ECOG performance status 0-1
  • Adequate hematological, renal and liver function

Exclusion Criteria:

  • Prior chemotherapy or treatment with another systemic anti-cancer agent
  • Radiotherapy within the last 4 weeks, except for limited field palliative radiotherapy for bone pain relief
  • Symptomatic or active CNS metastases
  • Recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)
  • Requirement for steroids > 40 mg prednisolone
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01185847
Other Study ID Numbers  ICMJE BP22349
2010-018945-72
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP