Non-small Cell Lung CancerSLATNCT00883480
Individualized Treatment Based on Epidermal Growth Factor Receptor Mutations and Level of BRCA1 Expression in Advanced Adenocarcinoma
A study testing Docetaxel, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by Spanish Lung Cancer Group at 2 sites in Spain.
Trial summary
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma. 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?
- Docetaxel, Cisplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 2 sitesSpain
- Study dates
- Jun 2005to Nov 2008
- Phase
- Interventional
- 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
- Patients age 18 years or more.
- Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
- Only patients with advanced disease, defined as stage IV or IIIB with/without pleural effusion, will be included.
- Tumor sample available.
- A measurable lesion, as defined by RECIST criteria.
- Karnofsky score 60% or more (ECOG < 2).
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- Patients should not have received previous treatment with chemotherapy or other agents for disseminated disease. Chemotherapy is allowed if the initial diagnosis of the patient is limited disease and the patient has received adjuvant or neoadjuvant treatment.
- Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
- Patients with hepatical, renal and hematology normality values.
- Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
- Patients of childbearing age of either sex must use effective contraceptive methods (barrier methods or other birth control methods) before entering the study and while participating in the study.
- Patients must be available for clinical follow-up..
Who cannot join
- Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
- Severe comorbidity.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Ico-Hospital Universitarios Germans Trias I Pujol
Badalona, Barcelona, 08916
Hospital Carlos Haya
Málaga, Málaga
About this study
Official title: Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Read the detailed description
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Docetaxel, Cisplatin, Gemcitabine, Erlotinib
- Keywords
- NSCLC
- 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.
DocetaxelDrug
Also called Taxotere
Docetaxel 75 mg/day 1 x 4 cycles
CisplatinDrug
Also called Platinol
Docetaxel-Cisplatin 75 mg/day 1 x 4 cycles
GemcitabineDrug
Also called Gemzar
Cisplatin 75 mg/ day 1 x 4 cycles
Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles
ErlotinibDrug
Also called Tarceva
Erlotinib 150 mg/day x 21 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | The rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Gemcitabine |
| 1 | Experimental | The group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumoral Response (RECIST criteria)
To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.
Measured: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
Secondary outcomes (1)
Overall Survival
Time from randomization until death from any cause. Patients who have not died during the study will be tabulated on their last date of evaluation.
Measured: From the date of randomization to the date of last follow up or death, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2009 (estimated)
- Study startJun 2005
- Primary completionJan 2008
- Study completionNov 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 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Lung Cancer Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Rosell, MD, Study chair, ICO-HOSPITAL GERMANS TRIAS I PUJOL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883480
- Sponsor's protocol ID
- SLAT
- Acronym
- SLAT
- Status last verified
- Jun 2022
- First submitted
- 22 Dec 2008
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Penas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS One. 2009;4(5):e5133. doi: 10.1371/journal.pone.0005133. Epub 2009 May 5.
PubMed 19415121
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tratamiento Individualizado en función de Las Mutaciones en EGFR y Del Nivel de expresión de BRCA1 en Pacientes Con Adenocarcinoma de pulmón Avanzado
- ClinicalTrials.gov ID
- NCT00883480
- Acronym / sponsor ID
- SLAT / SLAT
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Spanish Lung Cancer GroupUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Apr 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.
This is a pharmacogenic, prospective, and multicenter study in patients with advanced lung adenocarcinoma.
Detailed description
Pharmacogenomic study, prospective, multicenter. Individualized treatment based on EGFR mutations and level of BRCA1 expression in patients with advanced lung adenocarcinoma
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: GemcitabineThe rest of the patients who do not carry the Factor Receptor mutation of Epidermal Growth will receive chemotherapy treatment individualized based on BRCA 1 m RNA levels. Function of these levels, three different subgroups of treatment: Subgroup A with low BRCA1 mRNA levels will receive treatment with gemcitabine / cisplatin Subgroup B with intermediate levels of BRCA1 mRNA: will receive treatment with docetaxel / cisplatin Subgroup C with high levels of BRCA1 mRNA: will receive treatment with docetaxel |
| 1 | Experimental | Drug: ErlotinibThe group of patients carrying EGFR mutation will receive treatment with Erlotinib, a selective oral Receptor tyrosine kinase inhibitor Epidermal Growth Factor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients age 18 years or more.
- Histologically confirmed diagnosis of non-small-cell lung carcinoma.(and indifferentiated and BAC histology).
- Patients with cerebral disease are permitted, without any time limitations after holocranial irradiation or complementary antiedema treatment.
- Patients with hepatical, renal and hematology normality values.
- Patients should sign an informed consent form before inclusion in the study that specifies that the clinical trial treatment entails consent for the analysis of biological samples of tumor and blood.
Key exclusion criteria (2 listed)
- Patients who have received an investigational medicinal product in the 21 days before inclusion in the study or antiEGFR receptor agent.
- Severe 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 |
|---|---|---|
| DocetaxelAlso: TaxotereDocetaxel 75 mg/day 1 x 4 cycles | Drug | 2 |
| CisplatinAlso: PlatinolDocetaxel-Cisplatin 75 mg/day 1 x 4 cycles | Drug | 2 |
| GemcitabineAlso: GemzarCisplatin 75 mg/ day 1 x 4 cycles Gemcitabine 1250 mg/ day 1 and 8 x 4 cycles | Drug | 2 |
| ErlotinibAlso: TarcevaErlotinib 150 mg/day x 21 days | Drug | 1 |
Primary outcome
Tumoral Response (RECIST criteria)
Time frame: From date of end of experimental treatment until the date of last follow up, assessed up to 24 months]
To evaluate the tumor response of the treatment as measured by investigator-assessed overall response rate according to RECIST v1.1.
1 secondary outcome
Overall Survival
Time frame: From the date of randomization to the date of last follow up or death, assessed up to 24 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 28 Apr 2026.
- Derived from this study: PubMed 19415121Rosell R, Perez-Roca L, Sanchez JJ, Cobo M, Moran T, Chaib I, Provencio M, Domine M, Sala MA, Jimenez U, Diz P, Barneto I, Macias JA, de Las Penas R, Catot S, Isla D, Sanchez JM, Ibeas R, Lopez-Vivanco G, Oramas J, Mendez P, Reguart N, Blanco R, Taron M. Customized treatment in non-small-cell lung cancer based on EGFR mutations and BRCA1 mRNA expression. PLoS One. 2009;4(5):e5133. doi: 10.1371/journal.pone.0005133. Epub 2009 May 5.
- Individual participant dataSharing planned: No
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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.
Rafael Rosell, MD study chair
ICO-HOSPITAL GERMANS TRIAS I PUJOL
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel, Cisplatin and Gemcitabine in people with Non-small Cell Lung Cancer, run by Spanish Lung Cancer Group at 2 sites 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 12 inclusion and 2 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 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Tumoral Response (RECIST criteria) (time frame: From date of end of experimental treatment until the date of last follow up, assessed up to 24 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 NCT00883480, 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 28 Apr 2026.