Non-Small Cell Lung CancerPhase 2NCT00466284
Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer
A Phase 2 study testing Tarceva (erlotinib) in people with Non-Small Cell Lung Cancer, run by Grupo Gallego de Cancer de Pulmon at 1 site in Spain.
Trial summary
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated. STUDY OBJECTIVES Primary: Objective response rate Secondary: Progression free survival, Overall survival and Safety of Tarceva Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Tarceva (erlotinib)
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to not given
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years.
- Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
- Measurable disease.
- Written informed consent must be obtained prior to the inclusion into the trial.
- Karnofsky performance status of 80%.
- Patients must have been treated with no prior chemotherapy or radioterapy.
Show all 13Show fewer
- Patients must have adequate bone marrow, liver and renal function.
- Bone Marrow: WBC > 3000 x 103/mm3,
- Platelets > 100 x 103/mm3,
- Hgb > 10.0 gm/dl,
- ANC >1500 x 103/mm3,
- Hepatic:Bilirubin < 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase < 5 x normal,
- Renal:Creatinine < 1.5 mg/dl (132 µmol/l).
Who cannot join
- Female patients who are pregnant or lactating.
- Patients who have used other investigational agents within 21 days prior to study entry.
- Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
- Significant comorbidity.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Grupo Gallego de Cancer de Pulmon
Santiago de Compostela, A CORUÑA, 15701
Joaquin Casal, MD, joaquin.casal.rubio@sergas.es
About this study
Official title: Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.
STUDY OBJECTIVES
Primary: Objective response rate
Secondary: Progression free survival, Overall survival and Safety of Tarceva
Read the detailed description
Study Design: Phase II trial, open label, non-randomized and multicenter.
Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Tarceva (erlotinib)
- 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 (erlotinib)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Secondary outcomes (3)
Progression free survival
Overall survival
Safety of Tarceva
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2007 (estimated)
- Study startJan 2006
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants
Sponsor and investigators
- Lead sponsor
- Grupo Gallego de Cancer de Pulmon
- Sponsor type
- University, hospital or other
- Investigators
- Joquin Casal, MD, Principal investigator, GGCP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00466284
- Sponsor's protocol ID
- GGCP023/05-ML19497
- Status last verified
- Apr 2007
- First submitted
- 25 Apr 2007
- Last updated
- 27 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casal Rubio J, Firvida-Perez JL, Lazaro-Quintela M, Baron-Duarte FJ, Alonso-Jaudenes G, Santome L, Afonso-Afonso FJ, Amenedo M, Huidobro G, Campos-Balea B, Lopez-Vazquez MD, Vazquez S. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. Epub 2013 Dec 19.
PubMed 24352251
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Tarceva Following Concurrent Chemo-Radiotherapy as First Line Therapy in Patients With Unresectable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00466284
- Acronym / sponsor ID
- GGCP023/05-ML19497
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants
- Lead sponsor
- Grupo Gallego de Cancer de PulmonUniversity, hospital or other
- Study start
- Jan 2006
- First posted
- 27 Apr 2007 (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.
A open label non- randomized Phase II trial. It is anticipated that approximately 46 patients will be treated.
STUDY OBJECTIVES
Primary: Objective response rate
Secondary: Progression free survival, Overall survival and Safety of Tarceva
Detailed description
Study Design: Phase II trial, open label, non-randomized and multicenter.
Expected total enrollment: 46
Study start: January, 2006
Study completation: January, 2008
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years.
- Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB).
- Measurable disease.
- Written informed consent must be obtained prior to the inclusion into the trial.
- Karnofsky performance status of 80%.
Key exclusion criteria (4 listed)
- Female patients who are pregnant or lactating.
- Patients who have used other investigational agents within 21 days prior to study entry.
- Patients who have received prior treatment with erlotinib or other anti-EGFR agent.
- Significant comorbidity.
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 (erlotinib) | Drug | – |
Primary outcome
Objective response rate
3 secondary outcomes
Progression free survival
Overall survival
Safety of Tarceva
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2007.
- Derived from this study: PubMed 24352251Casal Rubio J, Firvida-Perez JL, Lazaro-Quintela M, Baron-Duarte FJ, Alonso-Jaudenes G, Santome L, Afonso-Afonso FJ, Amenedo M, Huidobro G, Campos-Balea B, Lopez-Vazquez MD, Vazquez S. A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study. Cancer Chemother Pharmacol. 2014 Mar;73(3):451-7. doi: 10.1007/s00280-013-2370-z. Epub 2013 Dec 19.
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)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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
NSCLC, Non-Small Cell Lung Cancer
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.
Joquin Casal, MD principal investigator
GGCP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarceva (erlotinib) in people with Non-Small Cell Lung Cancer, run by Grupo Gallego de Cancer de Pulmon at 1 site in Spain.
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 13 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2007. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin Casal, MD (986811111 ext. 645, joaquin.casal.rubio@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate. 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 NCT00466284, 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 27 Apr 2007.