Lung CancerPhase 3NCT00989690
Study of Blood and Tissue Samples in Predicting Response to Second-Line Therapy Using Erlotinib Hydrochloride or Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing docetaxel, erlotinib hydrochloride and pemetrexed disodium in people with Lung Cancer, run by Istituto Scientifico H. San Raffaele at 1 site in Italy.
Trial summary
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- docetaxel, erlotinib hydrochloride and pemetrexed disodium
- Type of treatment
- Surgery or procedure
- How many people
- 275 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to not given
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Advanced NSCLC (stage IIIB or IV)
- Measurable disease
- Underwent previous treatment with 1 non-tyrosine kinase inhibitor as first-line therapy for advanced NSCLC
- No clinical evidence of uncontrolled brain metastases
PATIENT CHARACTERISTICS:
- Caucasian
- ECOG performance status 0-2
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN) (≤ 2.5 times ULN in patients with known liver metastases)
- ALT or AST ≤ 3 times ULN (≤ 5 times ULN in patients with known liver metastases)
- Creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Able to comply with planned study procedures
- No multiple severe diseases that can compromise safety (cardiac and renal failure, peripheral neuropathy)
- No other malignancy (except for basal cell skin carcinoma) or pre-neoplastic condition requiring chemotherapeutic treatment
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 3 weeks since prior surgery or radiotherapy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Scientifico H. San Raffaele
Milan, 20132
Vanesa Gregor, MD, 39-02-2643-7623
About this study
Official title: Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients with advanced non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
- To evaluate the predictive value of proteomic profiling on the effect of second-line therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or docetaxel) in patients with advanced non-small cell lung cancer.
- To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras mutation).
OUTLINE: This is a multicenter study. Patients are stratified according to smoking status, performance status, proteomic profile, and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or another standard drug.
- Arm II: Patients receive standard non-chemotherapy treatment with erlotinib hydrochloride.
Serum is collected after failure of first-line therapy for proteomic analysis by matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein profile.
After completion of study treatment, patients are followed every 2 months.
- Conditions
- Lung Cancer
- Being tested
- docetaxel, erlotinib hydrochloride, pemetrexed disodium, fluorescence in situ hybridization, mutation analysis
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
erlotinib hydrochlorideDrug
pemetrexed disodiumDrug
fluorescence in situ hybridizationGenetic
mutation analysisGenetic
proteomic profilingGenetic
laboratory biomarker analysisOther
matrix-assisted laser desorption/ionization time of flight mass spectrometryOther
breath testProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (2)
Progression-free survival
Overall response rate according to RECIST criteria
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico H. San Raffaele
- Sponsor type
- University, hospital or other
- Investigators
- Vanesa Gregor, MD, Principal investigator, Istituto Scientifico H. San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989690
- Sponsor's protocol ID
- SRSI-HSRL-02-2007
- Other IDs
- CDR0000652115, 2007-006299-13, EU-20975
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Publications
Gregorc V, Novello S, Lazzari C, Barni S, Aieta M, Mencoboni M, Grossi F, De Pas T, de Marinis F, Bearz A, Floriani I, Torri V, Bulotta A, Cattaneo A, Grigorieva J, Tsypin M, Roder J, Doglioni C, Levra MG, Petrelli F, Foti S, Vigano M, Bachi A, Roder H. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial. Lancet Oncol. 2014 Jun;15(7):713-21. doi: 10.1016/S1470-2045(14)70162-7. Epub 2014 May 13.
PubMed 24831979
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib Versus Chemotherapy in Patients With Inoperable Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00989690
- Acronym / sponsor ID
- SRSI-HSRL-02-2007
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Istituto Scientifico H. San RaffaeleUniversity, hospital or other
- Study start
- Feb 2008
- First posted
- 5 Oct 2009 (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.
RATIONALE: Studying the proteins expressed in samples of blood and tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
PURPOSE: This randomized phase III trial is studying blood and tissue samples in predicting response to second-line therapy using erlotinib hydrochloride or chemotherapy in patients with advanced non-small cell lung cancer.
Detailed description
OBJECTIVES:
- To evaluate the predictive value of proteomic profiling on the effect of second-line therapy with erlotinib hydrochloride vs standard chemotherapy (pemetrexed disodium or docetaxel) in patients with advanced non-small cell lung cancer.
- To assess the role of other known tissue-based predictive markers (e.g., EGFR-gene copy number, EGFR-protein expression, pAkt, pMAPK, EGFR mutations, EMT markers, and k-Ras mutation).
OUTLINE: This is a multicenter study. Patients are stratified according to smoking status, performance status, proteomic profile, and participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive standard chemotherapy with pemetrexed disodium, docetaxel, or another standard drug.
- Arm II: Patients receive standard non-chemotherapy treatment with erlotinib hydrochloride.
Serum is collected after failure of first-line therapy for proteomic analysis by matrix-associated laser desorption/ionization-time of flight. Tissue and blood samples are collected periodically for analysis including EGFR based on IHC and FISH, EGFR and k-Ras mutations, pAkt, pMAPK by IHC, and EMT markers based on IHC and breath condensate protein profile.
After completion of study treatment, patients are followed every 2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| docetaxel | Drug | – |
| erlotinib hydrochloride | Drug | – |
| pemetrexed disodium | Drug | – |
| fluorescence in situ hybridization | Genetic | – |
| mutation analysis | Genetic | – |
| proteomic profiling | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| matrix-assisted laser desorption/ionization time of flight mass spectrometry | Other | – |
| breath test | Procedure or surgery | – |
Primary outcome
Overall survival
2 secondary outcomes
Progression-free survival
Overall response rate according to RECIST criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 24831979Gregorc V, Novello S, Lazzari C, Barni S, Aieta M, Mencoboni M, Grossi F, De Pas T, de Marinis F, Bearz A, Floriani I, Torri V, Bulotta A, Cattaneo A, Grigorieva J, Tsypin M, Roder J, Doglioni C, Levra MG, Petrelli F, Foti S, Vigano M, Bachi A, Roder H. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial. Lancet Oncol. 2014 Jun;15(7):713-21. doi: 10.1016/S1470-2045(14)70162-7. Epub 2014 May 13.
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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.
Vanesa Gregor, MD principal investigator
Istituto Scientifico H. San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing docetaxel, erlotinib hydrochloride and pemetrexed disodium in people with Lung Cancer, run by Istituto Scientifico H. San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00989690, which also lists 1 linked publication.
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 12 Aug 2013.