Non-Squamous Non-Small Cell Lung CancerPhase 2NCT01185847
A Study of RO5083945 in Combination With Chemotherapy Versus Chemotherapy Alone in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
A Phase 2 study testing RO5083945, cisplatin and gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 32 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Squamous Non-Small Cell Lung Cancer
- What is being tested?
- RO5083945, cisplatin and gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 32 sitesin 7 countries
- Study dates
- Nov 2010to Sep 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
32 sites in 7 countries.
32 sites in 7 countries
Spain8 sites
Study site
Barcelona, Barcelona, 08003
Study site
Barcelona, Barcelona, 08035
Study site
Madrid, Madrid, 28040
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28046
Study site
Madrid, Madrid, 28050
Study site
Málaga, Malaga, 29010
Study site
Seville, Sevilla, 41013
Germany7 sites
Study site
Bad Berka, 99437
Study site
Cologne, 51109
Study site
Gauting, 82131
Study site
Großhansdorf, 22927
Study site
Heidelberg, 69126
Study site
Mainz, 55131
Study site
Mannheim, 68167
Italy6 sites
Study site
Ancona, The Marches
Study site
Lido di Camaiore, Tuscany, 55043
Study site
Livorno, Tuscany, 57100
Study site
Milan, Lombardy, 20132
Study site
Milan, Lombardy, 20162
Study site
Perugia, Umbria, 06156
France4 sites
Study site
Caen, 14033
Study site
Marseille, 13915
Study site
Saint-Herblain, 44805
Study site
Toulouse, 31400
Belgium3 sites
Study site
Charleroi, B6000
Study site
Leuven, 3000
Study site
Liège, 4000
Poland3 sites
Study site
Lodz, 93-509
Study site
Otwock, 05-400
Study site
Warsaw, 02-781
About this study
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
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.
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Being tested
- RO5083945, cisplatin, gemcitabine, pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO5083945Drug
intravenously, until disease progression
cisplatinDrug
standard treatment, up to 6 cycles
gemcitabineDrug
standard treatment, up to 6 cycles
pemetrexedDrug
standard treatment, up to 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| A non-squamous | Experimental | Not described Receives: Drug: RO5083945; Drug: cisplatin; Drug: pemetrexed |
| A squamous | Experimental | Not described Receives: Drug: RO5083945; Drug: cisplatin; Drug: gemcitabine |
| B non-squamous | Active comparator | Not described Receives: Drug: cisplatin; Drug: pemetrexed |
| B squamous | Active comparator | Not described Receives: Drug: cisplatin; Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
Measured: 23 months
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
Measured: 6 months
Secondary outcomes (5)
Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed
Measured: multiple sampling cycles 1-6 (18 weeks)
Duration of response, according to RECIST criteria by CT/MRI
Measured: from response to disease progression
Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI
Measured: 23 months
Overall survival
Measured: 23 months
Overall response rate (ORR), according to RECIST criteria by CT/MRI
Measured: 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Squamous Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185847
- Sponsor's protocol ID
- BP22349
- Other IDs
- 2010-018945-72
- Status last verified
- Dec 2015
- First submitted
- 19 Aug 2010
- Last updated
- 1 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01185847
- Acronym / sponsor ID
- BP22349
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 20 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A non-squamous | Experimental | Drug: RO5083945, Drug: cisplatin, Drug: pemetrexed |
| A squamous | Experimental | Drug: RO5083945, Drug: cisplatin, Drug: gemcitabine |
| B non-squamous | Active comparator | Drug: cisplatin, Drug: pemetrexed |
| B squamous | Active comparator | Drug: cisplatin, Drug: gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO5083945intravenously, until disease progression | Drug | A non-squamous, A squamous |
| cisplatinstandard treatment, up to 6 cycles | Drug | A non-squamous, A squamous, B non-squamous, B squamous |
| gemcitabinestandard treatment, up to 6 cycles | Drug | A squamous, B squamous |
| pemetrexedstandard treatment, up to 6 cycles | Drug | A non-squamous, B non-squamous |
Primary outcome
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI
Time frame: 23 months
Part 1: Adverse event profile: adverse events, ECG, hematology, urinalysis, human anti-human antibodies (HAHA)
Time frame: 6 months
5 secondary outcomes
Pharmacokinetics of RO5083945 (AUC, Cmax and Cmin) in combination with cisplatin and gemcitabine/pemetrexed
Time frame: multiple sampling cycles 1-6 (18 weeks)
Duration of response, according to RECIST criteria by CT/MRI
Time frame: from response to disease progression
Clinical benefit rate (complete response, partial response or stable disease for >/=6 weeks), according to RECIST criteria by CT/MRI
Time frame: 23 months
Overall survival
Time frame: 23 months
Overall response rate (ORR), according to RECIST criteria by CT/MRI
Time frame: 23 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
32 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO5083945, cisplatin and gemcitabine in people with Non-Squamous Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 32 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Spain, Germany, Italy, France, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 2: Progression-free survival, according to RECIST criteria by CT/MRI (time frame: 23 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2016.