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

Phase 1

• Conditions: ocally advanced (stage IIIb), metastatic (IV) or recurrent, non-small cell lung cancer who have not received prior chemotherapy; MedDRA version: 14.1Level: LLTClassification code 10025077Term: Lung carcinoma stage IVSystem Organ Class: 100000004864; MedDRA version: 14.1Level: LLTClassification code 10025076Term: Lung carcinoma stage IIISystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2010-018945-72-BE
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-19
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>To demonstrate evidence of superior activity of RO5083945 added to cisplatin and gemcitabine/pemetrexed versus chemotherapy alone in terms of PFS;Secondary Objective: Overall survival, event driven, assessed at end of study event driven<br><br>Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), tumor assessments every 6 weeks<br><br>Duration of response tumor assessments every 6 weeks<br><br>Overall response rate (ORR) according to RECIST criteria tumor assessments every 6 weeks<br><br>Pharmacokinetics of RO5083945 in combination with cisplatin and gemcitabine/pemetrexed, multiple sampling cycles 1-6<br>;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<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Pharmacokinetics of RO5083945 in combination with of cisplatin, gemcitabine/pemetrexed<br>- Overall response rate (ORR) according to RECIST criteria by CT/MRI<br>- Duration of response according to RECIST criteria by CT/MRI<br>- Clinical benefit according to RECIST criteria by CT/MRI<br>- Overall survival <br>;Timepoint(s) of evaluation of this end point: Every 6 weeks<br>OS event driven, assessed at end of study (23 months)