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

Primary Purpose

Non-Squamous Non-Small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

RO5083945

cisplatin

gemcitabine

pemetrexed

About this trial

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

A non-squamous

A squamous

B non-squamous

B squamous

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

Overall survival

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

Full Information

NCT ID

NCT01185847

First Posted

August 19, 2010

Last Updated

December 31, 2015

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01185847

Brief Title

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

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Squamous Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A non-squamous

Arm Type

Experimental

Arm Title

A squamous

Arm Type

Experimental

Arm Title

B non-squamous

Arm Type

Active Comparator

Arm Title

B squamous

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

RO5083945

Intervention Description

intravenously, until disease progression

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

standard treatment, up to 6 cycles

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

standard treatment, up to 6 cycles

Intervention Type

Drug

Intervention Name(s)

pemetrexed

Intervention Description

standard treatment, up to 6 cycles

Primary Outcome Measure Information:

Title

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

Time Frame

23 months

Title

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

Time Frame

multiple sampling cycles 1-6 (18 weeks)

Title

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

Time Frame

from response to disease progression

Title

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

Time Frame

23 months

Title

Overall survival

Time Frame

23 months

Title

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

Time Frame

23 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Charleroi

ZIP/Postal Code

B6000

Country

Belgium

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

City

Liège

ZIP/Postal Code

4000

Country

Belgium

City

Caen

ZIP/Postal Code

14033

Country

France

City

Marseille

ZIP/Postal Code

13915

Country

France

City

Saint Herblain

ZIP/Postal Code

44805

Country

France

City

Toulouse

ZIP/Postal Code

31400

Country

France

City

Bad Berka

ZIP/Postal Code

99437

Country

Germany

City

Gauting

ZIP/Postal Code

82131

Country

Germany

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

City

Köln

ZIP/Postal Code

51109

Country

Germany

City

Mainz

ZIP/Postal Code

55131

Country

Germany

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

City

Milan

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

City

Ancona

State/Province

Marche

Country

Italy

City

Lido Di Camaiore

State/Province

Toscana

ZIP/Postal Code

55043

Country

Italy

City

Livorno

State/Province

Toscana

ZIP/Postal Code

57100

Country

Italy

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06156

Country

Italy

City

Lodz

ZIP/Postal Code

93-509

Country

Poland

City

Otwock

ZIP/Postal Code

05-400

Country

Poland

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

City

Madrid

ZIP/Postal Code

28040

Country

Spain

City

Madrid

ZIP/Postal Code

28041

Country

Spain

City

Madrid

ZIP/Postal Code

28046

Country

Spain

City

Madrid

ZIP/Postal Code

28050

Country

Spain

City

Malaga

ZIP/Postal Code

29010

Country

Spain

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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