Non-Small Cell Lung CancerPhase 2NCT00085839

Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

A Phase 2 study testing Tarceva (Trademark) (erlotinib HCl, OSI-774) and Combination carboplatin and paclitaxel in people with Non-Small Cell Lung Cancer, run by OSI Pharmaceuticals at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Tarceva (Trademark) (erlotinib HCl, OSI-774) and Combination carboplatin and paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 19 sitesUnited States
Study dates: Feb 2004to Mar 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
No prior chemotherapy
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Clinically or radiologically measurable disease per RECIST criteria

Who cannot join

Gastro-intestinal abnormalities
Any concurrent anticancer therapy
Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
Other active malignancies
Uncontrolled brain metastases
Severe abnormalities of the cornea
Significant cardiac disease

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Maryland Hematology/Oncology Associates
Baltimore, Maryland, 21237
FEK Addo, PC
Bismarck, North Dakota, 58503
Gabrail Cancer Center
Canton, Ohio, 44718
Charleston Hematology Oncology
Charleston, South Carolina, 29403
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210-1240
Evanston Northwestern Healthcare
Evanston, Illinois, 60201
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
California Cancer Care, Inc.
Greenbrae, California, 94904
East Tennessee Oncology/Hematology, PC
Knoxville, Tennessee, 37920
Norton Healthcare, Inc.
Louisville, Kentucky, 40202
University of Miami
Miami, Florida, 33136
Mount Sinai Cancer Center
Miami Beach, Florida, 33140
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Weill Medical College of Cornell University
New York, New York, 10021
Oncology/Hematology Associates of Central Illinois
Peoria, Illinois, 61615
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
VA Sierra Nevada Health Care System
Reno, Nevada, 89502
Sharp Clinical Oncology Research
San Diego, California, 92123

Other trials in United States

About this study

Official title: A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status

Conditions: Non-Small Cell Lung Cancer
Being tested: Tarceva (Trademark) (erlotinib HCl, OSI-774), Combination carboplatin and paclitaxel
Keywords: Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tarceva (Trademark) (erlotinib HCl, OSI-774)Drug
Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Combination carboplatin and paclitaxelDrug
Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Study groups in NCT00085839
Study group	Role	What they receive
Erlotinib	Experimental	Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy Receives: Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)
Standard Chemotherapy	Active comparator	Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles Receives: Drug: Combination carboplatin and paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free Survival
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Measured: Until time of disease progression (maximum 5 months)

Secondary outcomes (2)

Overall Survival
Median number of months from first study treatment until time of death
Measured: From first study treatment until time of death (maximum 26.8 months)
Best Tumor Response
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor 20% larger than at baseline.
Measured: While receiving study treatment (maximum 60 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2004Mar 2007

First posted17 Jun 2004 (estimated)
Study startFeb 2004
Primary completionMar 2007
Study completionMar 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00085839
Sponsor's protocol ID: OSI-774-201
Status last verified: Aug 2012
First submitted: 15 Jun 2004
Last updated: 9 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720.
PubMed 18281658

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Phase II Study of Single Agent Erlotinib [Tarceva (TM), OSI-774] Versus Standard Chemotherapy in Patients With Previously Untreated Advanced NSCLC and a Poor Performance Status
ClinicalTrials.gov ID: NCT00085839
Acronym / sponsor ID: OSI-774-201
Conditions: Non-Small Cell Lung Cancer
Keywords: Tarceva, NSCLC, EGFR, ECOG Performance Status 2, erlotinib, Non-Small Cell Lung Cancer, OSI-774
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: OSI PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2004
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 17 Jun 2004 (estimated)
Results: Posted 22 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Erlotinib	Experimental	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774)Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy
Standard Chemotherapy	Active comparator	Drug: Combination carboplatin and paclitaxelPaclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Stage IIIB or IV Nonsmall cell lung cancer (NSCLC)
No prior chemotherapy
Eastern Cooperative Oncology Group (ECOG) Performance Status 2
Clinically or radiologically measurable disease per RECIST criteria

Key exclusion criteria (7 listed)

Gastro-intestinal abnormalities
Any concurrent anticancer therapy
Prior treatment with epidermal growth factor receptor (EGFR) inhibitors of any kind
Other active malignancies
Uncontrolled brain metastases

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
Tarceva (Trademark) (erlotinib HCl, OSI-774)Erlotinib tablets administered orally, 150 mg/day (starting dose) or 100 mg/day (reduced dose), continuous therapy	Drug	Erlotinib
Combination carboplatin and paclitaxelPaclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 - 30 minutes, both given on Day 1 every 21 days for 4 cycles	Drug	Standard Chemotherapy

Primary outcome

Progression-free Survival
Time frame: Until time of disease progression (maximum 5 months)
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

2 secondary outcomes

Overall Survival
Time frame: From first study treatment until time of death (maximum 26.8 months)
Best Tumor Response
Time frame: While receiving study treatment (maximum 60 weeks)

Results and safety

Results posted to the registry on 22 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Erlotinib	52	52
Standard Chemotherapy	51	51

Primary outcome: Progression-free Survival

Time frame: Until time of disease progression (maximum 5 months). Median (95% Confidence Interval). Unit: months

Measure	Erlotinib n = 52	Standard Chemotherapy n = 51
Value	1.91 (1.28 to 2.69)	3.52 (1.48 to 4.73)

Population analysed: All patients who received at least 1 dose of study drug and who had both a baseline and at least one on-treatment tumor assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: While on study drug and 30 days after last dose. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib	24 of 52 (46.2%)	51 of 52 (98.1%)	Not reported
Standard Chemotherapy	13 of 51 (25.5%)	50 of 51 (98%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 18281658Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9. doi: 10.1200/JCO.2007.13.2720.
OSI Pharmaceuticals websiteLink provided by the sponsor.

Related trials for Non-Small Cell Lung Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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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.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (time frame: Until time of disease progression (maximum 5 months)). 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 NCT00085839, 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 9 Aug 2012.