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

NCT01185847 | Completed Phase 2

• 2 other identifiers: BP223492010-018945-72
• Study Type: interventional
• Target: 90
• Locations: 7 countries
• Sites: 32

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.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Part 2: Progression-free survival, according to RECIST criteria by CT/MRI

  23 months

• Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)

  6 months

Secondary Outcomes (5)

• Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed

  multiple sampling cycles 1-6 (18 weeks)

• Duration of response, according to RECIST criteria by CT/MRI

  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

  23 months

• Overall survival

  23 months

• Overall response rate (ORR), according to RECIST criteria by CT/MRI

  23 months

Study Arms (4)

A non-squamous

EXPERIMENTAL

Drug: RO5083945; Drug: cisplatin; Drug: pemetrexed

A squamous

EXPERIMENTAL

Drug: RO5083945; Drug: cisplatin; Drug: gemcitabine

B non-squamous

ACTIVE COMPARATOR

Drug: cisplatin; Drug: pemetrexed

B squamous

ACTIVE COMPARATOR

Drug: cisplatin; Drug: gemcitabine

Interventions

RO5083945 DRUG

intravenously, until disease progression

A non-squamous; A squamous

cisplatin DRUG

standard treatment, up to 6 cycles

A non-squamous; A squamous; B non-squamous; B squamous

gemcitabine DRUG

standard treatment, up to 6 cycles

A squamous; B squamous

pemetrexed DRUG

standard treatment, up to 6 cycles

A non-squamous; B non-squamous

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (32)

Unknown Facility

Charleroi, B6000, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Caen, 14033, France

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Marseille, 13915, France

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Saint-Herblain, 44805, France

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Toulouse, 31400, France

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Bad Berka, 99437, Germany

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Cologne, 51109, Germany

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Gauting, 82131, Germany

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Großhansdorf, 22927, Germany

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Heidelberg, 69126, Germany

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Mainz, 55131, Germany

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Mannheim, 68167, Germany

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20162, Italy

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Ancona, The Marches, Italy

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Lido di Camaiore, Tuscany, 55043, Italy

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Livorno, Tuscany, 57100, Italy

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Perugia, Umbria, 06156, Italy

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Lodz, 93-509, Poland

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Otwock, 05-400, Poland

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Warsaw, 02-781, Poland

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08035, Spain

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Madrid, Madrid, 28040, Spain

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Madrid, Madrid, 28041, Spain

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Madrid, Madrid, 28046, Spain

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Madrid, Madrid, 28050, Spain

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Málaga, Malaga, 29010, Spain

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Seville, Sevilla, 41013, Spain

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London, SE1 9RT, United Kingdom

Location

MeSH Terms

Interventions

imgatuzumab; Cisplatin; Gemcitabine; Pemetrexed

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 20, 2010
• Study Start: November 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 1, 2016

Record last verified: 2015-12

Locations

DE (7); FR (4); PL (3); IT (6); GB (1); BE (3); ES (8)