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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: RO5083945 Drug: cisplatin Drug: gemcitabine Drug: pemetrexed Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A non-squamous Drug: RO5083945
intravenously, until disease progression

Drug: cisplatin
standard treatment, up to 6 cycles

Drug: pemetrexed
standard treatment, up to 6 cycles
Experimental: A squamous Drug: RO5083945
intravenously, until disease progression

Drug: cisplatin
standard treatment, up to 6 cycles

Drug: gemcitabine
standard treatment, up to 6 cycles
Active Comparator: B non-squamous Drug: cisplatin
standard treatment, up to 6 cycles

Drug: pemetrexed
standard treatment, up to 6 cycles
Active Comparator: B squamous Drug: cisplatin
standard treatment, up to 6 cycles

Drug: gemcitabine
standard treatment, up to 6 cycles


Outcome Measures
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Primary Outcome Measures :
  1. Part 2: Progression-free survival, according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  2. Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed [ Time Frame: multiple sampling cycles 1-6 (18 weeks) ]
  2. Duration of response, according to RECIST criteria by CT/MRI [ Time Frame: from response to disease progression ]
  3. Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]
  4. Overall survival [ Time Frame: 23 months ]
  5. Overall response rate (ORR), according to RECIST criteria by CT/MRI [ Time Frame: 23 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01185847


Locations
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Belgium
Charleroi, Belgium, B6000
Leuven, Belgium, 3000
Liège, Belgium, 4000
France
Caen, France, 14033
Marseille, France, 13915
Saint Herblain, France, 44805
Toulouse, France, 31400
Germany
Bad Berka, Germany, 99437
Gauting, Germany, 82131
Grosshansdorf, Germany, 22927
Heidelberg, Germany, 69126
Köln, Germany, 51109
Mainz, Germany, 55131
Mannheim, Germany, 68167
Italy
Milano, Lombardia, Italy, 20162
Milan, Lombardia, Italy, 20132
Ancona, Marche, Italy
Lido Di Camaiore, Toscana, Italy, 55043
Livorno, Toscana, Italy, 57100
Perugia, Umbria, Italy, 06156
Poland
Lodz, Poland, 93-509
Otwock, Poland, 05-400
Warszawa, Poland, 02-781
Spain
Barcelona, Spain, 08003
Barcelona, Spain, 08035
Madrid, Spain, 28040
Madrid, Spain, 28041
Madrid, Spain, 28046
Madrid, Spain, 28050
Malaga, Spain, 29010
Sevilla, Spain, 41013
United Kingdom
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01185847    
Other Study ID Numbers: BP22349
2010-018945-72
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gemcitabine
Cisplatin
Pemetrexed
 Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors