Non-Small Cell Lung CancerPhase 2NCT01998919
A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.
A Phase 2 study testing erlotinib [Tarceva], gemcitabine and cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 19 sites in 8 countries.
Trial summary
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. 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?
- erlotinib [Tarceva], gemcitabine and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Aug 2006to Nov 2011
- 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;
- histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- measurable disease;
- no previous chemotherapy for non-small cell lung cancer.
Who cannot join
- unstable systemic disease;
- any other malignancies in the last 5 years.
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
China4 sites
Study site
Guangzhou, 510060
Study site
Guangzhou, 510080
Study site
Shanghai, 200030
Study site
Shanghai, 200433
Indonesia4 sites
Study site
Jakarta, 10410
Study site
Jakarta, 10430
Study site
Semarang, 50136
Study site
Yogyakarta, 55284
Australia3 sites
Study site
Campbelltown, 2560
Study site
Camperdown, 2050
Study site
Liverpool, 2170
About this study
Official title: A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- erlotinib [Tarceva], placebo, gemcitabine, cisplatin, carboplatin
- 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.
erlotinib [Tarceva]Drug
150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
placeboDrug
orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
gemcitabineDrug
1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
cisplatinDrug
75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
carboplatinDrug
5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Tarceva + gemcitabine/platinum | Experimental | Not described Receives: Drug: erlotinib [Tarceva]; Drug: gemcitabine; Drug: cisplatin; Drug: carboplatin |
| Placebo + gemcitabine/platinum | Placebo comparator | Not described Receives: Drug: placebo; Drug: gemcitabine; Drug: cisplatin; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
Measured: Week 8
Secondary outcomes (6)
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Non-progression defined as documented best overall tumor response of CR, PR, or SD (where SD was maintained for >16 weeks) per RECIST.
Measured: Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
CR=disappearance of all target lesions; PR=at least a 30% decrease in sum of LD of target lesions, taking as reference the baseline sum LD.
Measured: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Duration of Response
Duration of Response was defined similarly for complete responders and partial responders. CR was defined as the date CR was first recorded to the date on which PD was first noted or date of death. PR was defined as the date the first PR was recorded to the date of the first observation of PD or date of death.
Measured: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Time to Progression
Time to progression was defined as the interval between the day of randomization and the first documentation of PD. Participants who were withdrawn from the study without documented progression and for whom there exists CRF evidence that evaluations have been made, were censored at 1) the date of the last tumor assessment, 2) last date in the drug log, or 3) last date of follow-up when the participant was known to be progression free, whichever was last. Participants without post-baseline tumor assessments but known to be alive were censored at the time of randomization.
Measured: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Progression-Free Survival (PFS)
PFS was defined as the interval between the day of randomization and the date of first documentation of progressive disease or date of death, whichever came first.
Measured: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Overall Survival
Overall Survival (OS) was defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment.
Measured: Date of randomization until date of death or date of last follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startAug 2006
- Primary completionNov 2011
- Study completionNov 2011
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 CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study chair, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998919
- Sponsor's protocol ID
- MO18633
- Status last verified
- Dec 2014
- First submitted
- 25 Nov 2013
- Last updated
- 13 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind Phase II of Sequential Administration of Tarceva (Erlotinib) or Placebo in Combination With Gemcitabine/Platinum as First-line Treatment in Patients With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC).
- ClinicalTrials.gov ID
- NCT01998919
- Acronym / sponsor ID
- MO18633
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Dec 2013 (estimated)
- Results
- Posted 9 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tarceva + gemcitabine/platinum | Experimental | Drug: erlotinib [Tarceva], Drug: gemcitabine, Drug: cisplatin, Drug: carboplatin |
| Placebo + gemcitabine/platinum | Placebo comparator | Drug: placebo, Drug: gemcitabine, Drug: cisplatin, Drug: carboplatin |
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;
- histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;
- measurable disease;
- no previous chemotherapy for non-small cell lung cancer.
Key exclusion criteria (2 listed)
- unstable systemic disease;
- any other malignancies in the last 5 years.
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 |
|---|---|---|
| erlotinib [Tarceva]150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily | Drug | Tarceva + gemcitabine/platinum |
| placeboorally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application | Drug | Placebo + gemcitabine/platinum |
| gemcitabine1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles | Drug | Placebo + gemcitabine/platinum, Tarceva + gemcitabine/platinum |
| cisplatin75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin | Drug | Placebo + gemcitabine/platinum, Tarceva + gemcitabine/platinum |
| carboplatin5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin | Drug | Placebo + gemcitabine/platinum, Tarceva + gemcitabine/platinum |
Primary outcome
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Week 8
Non-progression defined as documented best overall tumor response of complete response (CR), partial response (PR), or stable disease (SD; where SD was maintained for greater than [>]8 weeks) per RECIST. Investigator's assessment of response used in all analyses. CR equals (=)disappearance of all target lesions; PR=at least a 30 percent (%) decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference smallest sum LD since treatment started.
6 secondary outcomes
Percentage of Participants With Non-Progression at Week 16 as Assessed by RECIST
Time frame: Week 16
Percentage of Participants With Confirmed CR or PR as Assessed by RECIST
Time frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Duration of Response
Time frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-study Phases
Time to Progression
Time frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Progression-Free Survival (PFS)
Time frame: Screening/Baseline, Day 22 of Cycles 2, 4 and 6 and every 8 weeks in Post-Study and Off-Study Phases
Overall Survival
Time frame: Date of randomization until date of death or date of last follow-up assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Trials study chair
Hoffmann-La Roche
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing erlotinib [Tarceva], gemcitabine and cisplatin in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 19 sites in 8 countries.
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 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 13 Jan 2015. 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 China, Indonesia, Australia, Philippines, Taiwan and 3 more countries. 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. Some participants in this study may receive a placebo. 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 9 Jul 2014). 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?
Percentage of Participants With Non-Progression at Week 8 as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2015.