A study of RO5083945 in combination with chemotherapy versus chemotherapy alone in patients with advanced or recurrent non-small cell lung cancer

• Register: EUCTR
• Last refreshed on: 28 October 2013
• Main ID: EUCTR2010-018945-72-DE
• Date of registration: 18/06/2010
• Prospective Registration: Yes
• Primary sponsor: F.Hoffmann-La Roche
• Public title: A study of RO5083945 in combination with chemotherapy versus chemotherapy alone in patients with advanced or recurrent non-small cell lung cancer
• Scientific 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
• Date of first enrolment: 27/08/2010
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-018945-72
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: yes Other trial design description: stratified If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Germany, United Kingdom

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

Inclusion criteria:
- adult patients, >/=18 years of age
- advanced, metastatic 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

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
- history or clinical evidence of CNS metastases
- recent history of poorly controlled hypertension (systolic >180mmHg or diastolic >100mmHg)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Locally advanced (stage IIIb), metastatic (IV) or recurrent, non-small cell lung cancer who have not received prior chemotherapy
MedDRA version: 14.1 Level: LLT Classification code 10025077 Term: Lung carcinoma stage IV System Organ Class: 100000004864
MedDRA version: 14.1 Level: LLT Classification code 10025076 Term: Lung carcinoma stage III System Organ Class: 100000004864

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

Product Name: GA201
Product Code: RO5083945/F02
Pharmaceutical Form: Solution for infusion
CAS Number: 959963-46-3
Current Sponsor code: RO5083945
Other descriptive name: huMab (GA201)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Product Name: GA201
Product Code: RO5083945/F03
Pharmaceutical Form: Solution for infusion
CAS Number: 959963-46-3
Current Sponsor code: RO5083945
Other descriptive name: huMab (GA201)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Main Objective: To describe by histology group the adverse event profile, pharmacokinetics (PK) and recommended dose of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed

To demonstrate evidence of superior activity of RO5083945 added to cisplatin and gemcitabine/pemetrexed versus chemotherapy alone in terms of PFS

Timepoint(s) of evaluation of this end point: Every 6 weeks

Secondary Objective: Overall survival, event driven, assessed at end of study event driven

Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), tumor assessments every 6 weeks

Duration of response tumor assessments every 6 weeks

Overall response rate (ORR) according to RECIST criteria tumor assessments every 6 weeks

Pharmacokinetics of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed, multiple sampling cycles 1-6

Primary end point(s): Progession free survival, according to RECIST criteria by CT/MRI

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Every 6 weeks
OS event driven, assessed at end of study (23 months)

Secondary end point(s): - Pharmacokinetics of RO5083945 in combination with of cisplatin, gemcitabine/pemetrexed
- Overall response rate (ORR) according to RECIST criteria by CT/MRI
- Duration of response according to RECIST criteria by CT/MRI
- Clinical benefit according to RECIST criteria by CT/MRI
- Overall survival

Secondary ID(s)

BP22349

NCT01185447

Source(s) of Monetary Support

F.Hoffmann-La Roche Ltd