Carcinoma, Non-Small-Cell LungPhase 3ADVIGO1017NCT00907504
Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
A Phase 3 study testing CP-751,871, Cisplatin and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer.
Trial summary
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- CP-751,871, Cisplatin and Gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2014
- Phase
- Phase 3
- 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
- Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
- Male or female > 18 years
- Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
- Adequate organ function
Who cannot join
- Uncontrolled hypertension or diabetes;
- Pregnant female;
- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
About this study
Official title: Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- CP-751,871, Cisplatin, Gemcitabine
- 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.
CP-751,871Drug
CP-751,871 20mg/kg every 3 weeks
CisplatinDrug
Cisplatin 80 mg/m2 every 3 weeks
GemcitabineDrug
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
CisplatinDrug
Cisplatin 80 mg/m2 every 3 weeks
GemcitabineDrug
Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle
| Study group | Role | What they receive |
|---|---|---|
| CP-751,871 + Gemcitabine + Cisplatin | Experimental | investigational arm Receives: Drug: CP-751,871; Drug: Cisplatin; Drug: Gemcitabine |
| Gemcitabine + Cisplatin | Active comparator | standard of care Receives: Drug: Cisplatin; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: Dec 2012
Secondary outcomes (7)
Progression Free survival
Measured: Dec 2011
Objective Response
Measured: Dec 2011
Overall Safety Profile
Measured: Dec 2012
Patient Reported Outcome
Measured: Dec 2012
Pharmacokinetics
Measured: Dec 2012
Anti-drug Antibody
Measured: Dec 2012
Biomarker Analysis
Measured: Dec 2012
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJul 2010
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907504
- Sponsor's protocol ID
- A4021017
- Acronym
- ADVIGO1017
- Status last verified
- Jun 2014
- First submitted
- 20 May 2009
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00907504
- Acronym / sponsor ID
- ADVIGO1017 / A4021017
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 22 May 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.
Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CP-751,871 + Gemcitabine + Cisplatin | Experimental | Drug: CP-751,871, Drug: Cisplatin, Drug: Gemcitabineinvestigational arm |
| Gemcitabine + Cisplatin | Active comparator | Drug: Cisplatin, Drug: Gemcitabinestandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
- Male or female > 18 years
- Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
- Adequate organ function
Key exclusion criteria (3 listed)
- Uncontrolled hypertension or diabetes;
- Pregnant female;
- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.
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 |
|---|---|---|
| CP-751,871CP-751,871 20mg/kg every 3 weeks | Drug | CP-751,871 + Gemcitabine + Cisplatin |
| CisplatinCisplatin 80 mg/m2 every 3 weeks | Drug | CP-751,871 + Gemcitabine + Cisplatin |
| GemcitabineGemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle | Drug | CP-751,871 + Gemcitabine + Cisplatin |
| CisplatinCisplatin 80 mg/m2 every 3 weeks | Drug | Gemcitabine + Cisplatin |
| GemcitabineGemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle | Drug | Gemcitabine + Cisplatin |
Primary outcome
Overall Survival
Time frame: Dec 2012
7 secondary outcomes
Progression Free survival
Time frame: Dec 2011
Objective Response
Time frame: Dec 2011
Overall Safety Profile
Time frame: Dec 2012
Patient Reported Outcome
Time frame: Dec 2012
Pharmacokinetics
Time frame: Dec 2012
Anti-drug Antibody
Time frame: Dec 2012
Biomarker Analysis
Time frame: Dec 2012
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Carcinoma, Non-Small-Cell Lung
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.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CP-751,871, Cisplatin and Gemcitabine in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer.
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: withdrawn, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Survival (time frame: Dec 2012). 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 17 Jun 2014.