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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018945-72-DE

Enrollment

160

Registered

2010-06-18

Start date

2010-08-27

Completion date

Unknown

Last updated

2013-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 u

Eligibility

Sex/Gender

All

Inclusion 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

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)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Progession free survival, according to RECIST criteria by CT/MRI;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 ;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	—

Measure

Time frame

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

—

Secondary

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

Measure

Time frame

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

—

Countries

Germany, United Kingdom

Contacts

Public ContactTrial Information Support Line-TISL

F.Hoffmann-La Roche Ltd

global.rochegenentechtrials@roche.com41616881111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026