Non-small Cell Lung Cancer MetastaticPhase 2NCT00701558

A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Unresectable Advanced and/or Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing Erlotinib and Gemcitabine in people with Non-small Cell Lung Cancer Metastatic, run by Hoffmann-La Roche at 1 site in Romania.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer Metastatic
What is being tested?: Erlotinib and Gemcitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteRomania
Study dates: Aug 2008to Dec 2010
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

adult patients, >=18 years of age;
advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
no previous systemic chemotherapy, radiation therapy or immunotherapy;
Eastern Cooperative Oncology Group (ECOG) >=2.

Who cannot join

prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
active, non-controlled systemic disease;
any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

Trial locations and contacts

1 site in 1 country.

Romania1 site

Study site
Bucharest, 022328

Other trials in Romania

About this study

Official title: An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer

This single arm study will assess the efficacy and safety of erlotinib + gemcitabine in chemotherapy-naive participants with unresectable, advanced and/or metastatic non-small cell lung cancer. Participants will receive erlotinib 150 mg orally (po) daily, in combination with gemcitabine 1000 mg/m^2 intravenously (iv) weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Conditions: Non-small Cell Lung Cancer Metastatic
Being tested: Erlotinib, Gemcitabine

What participants receive

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

ErlotinibDrug
Also called Tarceva
150 mg po daily
GemcitabineDrug
1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles

Study groups in NCT00701558
Study group	Role	What they receive
Erlotinib + Gemcitabine	Experimental	Participants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death. Receives: Drug: Erlotinib; Drug: Gemcitabine

What is being measured

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

Time to Disease Progression
Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Measured: From the time of randomization until disease progression or death (up to 193 weeks)]
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: From the time of randomization until disease progression or death (up to 193 weeks)

Secondary outcomes (1)

Overall Survival
Overall survival was defined as the interval between the day of randomization and the date of death from any cause.
Measured: From the time of randomization until death (up to 193 weeks)

Timeline

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

Aug 2008Dec 2010

First posted19 Jun 2008 (estimated)
Study startAug 2008
Primary completionOct 2010
Study completionDec 2010

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.
Other trials for Non-small Cell Lung Cancer MetastaticStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00701558
Sponsor's protocol ID: ML20951
Other IDs: 2007-002135-83
Status last verified: May 2016
First submitted: 18 Jun 2008
Last updated: 24 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

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)
Solid Tumor, Non-Small Cell Lung Cancer
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A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
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
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer

All Non-small Cell Lung Cancer Metastatic trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Disease Progression in Patients With Unresectable Advanced and/or Metastatic Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00701558
Acronym / sponsor ID: ML20951
Conditions: Non-small Cell Lung Cancer Metastatic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2008
Primary completion: Oct 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 19 Jun 2008 (estimated)
Results: Posted 19 May 2016

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Erlotinib + Gemcitabine	Experimental	Drug: Erlotinib, Drug: GemcitabineParticipants received erlotinib 150 mg/day, orally (po) on a continuous schedule in combination with gemcitabine at 1000 mg/m^2 administered intravenously (iv) on days 1, 8, 15 of each 4 week cycle for 6 cycles as per standard medical care, or until disease progression or participant's withdrawal due to any reason or death.

Who may qualify

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

Key inclusion criteria (4 listed)

adult patients, >=18 years of age;
advanced and/or metastatic (stage IIIB/IV) unresectable non-small cell lung cancer;
no previous systemic chemotherapy, radiation therapy or immunotherapy;
Eastern Cooperative Oncology Group (ECOG) >=2.

Key exclusion criteria (3 listed)

prior systemic anti-tumor therapy with human epidermal growth factor receptor 1 (HER1/EGFR) inhibitors;
active, non-controlled systemic disease;
any other malignancies within 5 years (except for adequately treated cancer in situ of cervix, or basal or squamous cell skin cancer).

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
ErlotinibAlso: Tarceva150 mg po daily	Drug	Erlotinib + Gemcitabine
Gemcitabine1000 mg/m^2 iv on days 1, 8, 15 of each 4 week cycle for 6 cycles	Drug	Erlotinib + Gemcitabine

Primary outcome

Time to Disease Progression
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)]
Time to disease progression or progression free survival (PFS) was defined as the interval between the day of randomization and the date of the first documentation of disease progression or date of death (from any cause), whichever occurs first.
Overall Response Rate (ORR)
Time frame: From the time of randomization until disease progression or death (up to 193 weeks)
Overall response rate was defined as the percentage of participants who had any evidence of confirmed objective complete response (CR) or partial response (PR), per the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) and assessed by computed tomography imaging (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

1 secondary outcome

Overall Survival
Time frame: From the time of randomization until death (up to 193 weeks)

Results and safety

Results posted to the registry on 19 May 2016, 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 + Gemcitabine	19	4

Primary outcome: Time to Disease Progression

Time frame: From the time of randomization until disease progression or death (up to 193 weeks)]. Median (95% Confidence Interval). Unit: weeks

Measure	Erlotinib + Gemcitabine n = 18
Value	15 (7 to 36)

Population analysed: Intention to treat (ITT) population included all participants who were randomized to treatment group.

Primary outcome: Overall Response Rate (ORR)

Time frame: From the time of randomization until disease progression or death (up to 193 weeks). Number. Unit: percentage of participants

Measure	Erlotinib + Gemcitabine n = 19
Value	15.8

Population analysed: ITT population included all participants who were randomized to treatment group.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 28 days after last study drug administration in the study treatment phase (up to 197 Weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Erlotinib + Gemcitabine	2 of 19 (10.5%)	15 of 19 (78.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Non-small Cell Lung Cancer Metastatic

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
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
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), 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.

Clinical Trials study director

Hoffmann-La Roche

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 Erlotinib and Gemcitabine in people with Non-small Cell Lung Cancer Metastatic, run by Hoffmann-La Roche at 1 site in Romania.

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 3 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 24 Jun 2016. 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 Romania. 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 19 May 2016). 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?

Time to Disease Progression (time frame: From the time of randomization until disease progression or death (up to 193 weeks)]). 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?

On the ClinicalTrials.gov record for NCT00701558.

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 24 Jun 2016.