Clinical trial NCT01185847: A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
timeFrame: 23 months
measure: Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
timeFrame: 6 months
Secondary outcomes:
measure: Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed
timeFrame: multiple sampling cycles 1-6 (18 weeks)
measure: Duration of response, according to RECIST criteria by CT/MRI
timeFrame: from response to disease progression
measure: Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI
timeFrame: 23 months
measure: Overall survival
timeFrame: 23 months
measure: Overall response rate (ORR), according to RECIST criteria by CT/MRI
timeFrame: 23 months
Other outcomes:
Locations:
city: Charleroi
country: Belgium
city: Leuven
country: Belgium
city: Liège
country: Belgium
city: Caen
country: France
city: Marseille
country: France
city: Saint Herblain
country: France
city: Toulouse
country: France
city: Bad Berka
country: Germany
city: Gauting
country: Germany
city: Grosshansdorf
country: Germany
city: Heidelberg
country: Germany
city: Köln
country: Germany
city: Mainz
country: Germany
city: Mannheim
country: Germany
city: Milano
country: Italy
state: Lombardia
city: Milan
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Livorno
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Lodz
country: Poland
city: Otwock
country: Poland
city: Warszawa
country: Poland
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: London
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: