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NCT Number: NCT01185847

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

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.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charleroi, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RO5083945

Drug

intravenously, until disease progression

Cisplatin

Drug

standard treatment, up to 6 cycles

Gemcitabine

Drug

standard treatment, up to 6 cycles

Pemetrexed

Drug

standard treatment, up to 6 cycles

Primary outcomes

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

    Time frame: 23 months

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

    Time frame: 6 months

Secondary outcomes

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

    Time frame: multiple sampling cycles 1-6 (18 weeks)

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

    Time frame: from response to disease progression

  3. Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI

    Time frame: 23 months

  4. Overall survival

    Time frame: 23 months

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

    Time frame: 23 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 20, 2010
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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