Carcinoma, Non-Small Cell LungPhase 1/2NCT00768755
Evaluation Of The Efficacy Of The Combination Of Axitinib With Pemetrexed And Cisplatin In The Treatment Of Non-Squamous Non-Small Cell Lung Cancer
A Phase 1/2 study testing axitinib and chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 52 sites in 11 countries.
Trial summary
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC). 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?
- axitinib and chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 52 sitesin 11 countries
- Study dates
- Jan 2009to Mar 2012
- Phase
- Phase 1/2
- 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
- Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
- Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
- Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
- Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
- Candidate for primary treatment with cisplatin and pemetrexed
Who cannot join
- Any histological/cytological evidence of predominantly squamous NSCLC.
- Small cell or carcinoid lung cancer patients are also ineligible.
- NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
- Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
- Prior treatment with a VEGF or VEGFR inhibitor.
Trial locations and contacts
52 sites in 11 countries.
52 sites in 11 countries
United States12 sites
Pfizer Investigational Site
Atlanta, Georgia, 30341
Pfizer Investigational Site
Bloomington, Illinois, 61701
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
East Providence, Rhode Island, 02914
Pfizer Investigational Site
East Providence, Rhode Island, 02915
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Huntsville, Alabama, 35805
Pfizer Investigational Site
Macon, Georgia, 31217
Pfizer Investigational Site
Marietta, Georgia, 30060
Pfizer Investigational Site
Peoria, Illinois, 61615
Pfizer Investigational Site
Sandy Springs, Georgia, 30342
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Poland7 sites
Pfizer Investigational Site
Lubin, 59-300
Pfizer Investigational Site
Otwock, 05-400
Pfizer Investigational Site
Piła, 64-920
Pfizer Investigational Site
Poznan, 60-569
Pfizer Investigational Site
Poznan, 61-485
Pfizer Investigational Site
Prabuty, 82-550
Pfizer Investigational Site
Warsaw, 00-909
United Kingdom7 sites
Pfizer Investigational Site
Bournemouth, BH7 7DW
Pfizer Investigational Site
Brighton, BN2 5BE
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
Middlesex, HA6 2RN
Pfizer Investigational Site
Northwood, Middlesex, HA6 2RN
Pfizer Investigational Site
Poole, BH15 2JB
Pfizer Investigational Site
Romford, Essex, RM7 0AG
Spain6 sites
Pfizer Investigational Site
Castellon, Castellon, 12002
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Palma de Mallorca, Palma de Mallorca, 07010
Pfizer Investigational Site
Seville, Sevilla, 41009
Pfizer Investigational Site
Terrassa, Barcelona, 08221
Russia4 sites
Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Pyatigorsk, 357502
Pfizer Investigational Site
Saint Petersburg, 194044
Pfizer Investigational Site
Saint Petersburg, 197089
Switzerland4 sites
Pfizer Investigational Site
Basel, CH-4016
Pfizer Investigational Site
Basel, CH-4031
Pfizer Investigational Site
Bruderholz, CH-4101
Pfizer Investigational Site
Liestal, CH-4410
Taiwan4 sites
Pfizer Investigational Site
Taichung, 402
Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 112
Italy3 sites
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Lido Di Camaiore (LU), 55043
Pfizer Investigational Site
Orbassano (TO), 10043
Romania2 sites
Pfizer Investigational Site
Bacau, Bacău, 600114
Pfizer Investigational Site
Iași, Iaşi, 700106
Ukraine2 sites
Pfizer Investigational Site
Dnipropetrovsk, 49102
Pfizer Investigational Site
Kyiv, 03115
About this study
Official title: Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- axitinib, chemotherapy
- Keywords
- non-squamous NSCLC, axitinib, pemetrexed/cisplatin
- 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.
axitinibDrug
Also called AG-013736
5mg BID po up to max 10mg BID po
axitinibDrug
Also called AG-013736
5mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy
chemotherapyDrug
Also called alimta
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
axitinibDrug
5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy
chemotherapyDrug
Also called alimta
Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Axitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance Receives: Drug: axitinib |
| II | Experimental | Axitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance Receives: Drug: axitinib |
| III | Active comparator | pemetrexed and cisplatin Receives: Drug: chemotherapy |
| IV | Experimental | Axitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance Receives: Drug: axitinib |
| V | Active comparator | pemetrexed and cisplatin Receives: Drug: chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was "Death") or from the end of study data.
Measured: Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Secondary outcomes (5)
Overall Survival (OS)
Time in months from the date of randomization to date of death due to any cause. OS was calculated as (the death date minus the date of randomization plus 1) divided by 30.4. Death was determined from AE data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR)/confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors(RECIST).Confirmed responses: those persist on repeat imaging study at least 4 weeks after initial documentation of response.CR: disappearance of all lesions (target/non target) and no appearance of new lesions.PR: those with at least 30 % decrease in sum of longest dimensions of target lesions taking as reference baseline sum longest dimensions,without progression of non target lesions and no appearance of new lesions.
Measured: Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Duration of Response (DR)
Time in months from the first documentation of objective tumor response to objective tumor progression or death due to any cause, whichever occurs first. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Measured: Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score
Symptom severity score is comprised of average of 13 MDASI core items (pain, fatigue, nausea, disturbed sleep, distressed, shortness of breath, remembering things, lack of appetite, drowsy, dry mouth, sadness, vomiting, numbness or tingling) and ranges from 0 to 10. Participants were asked to rate severity of each symptom at their worst in last 24 hours; each item rated from 0 to 10, with 0 = symptom not present and 10 = as bad as you can imagine. Lower scores indicated better outcome.
Measured: Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score
Symptom interference score is comprised of average of 6 function items from MDASI core (general activity, mood, work, relations with others, walking, and enjoyment of life) and ranges from 0 to 10. Participants were asked to rate how much symptoms have interfered in last 24 hours; each item rated from 0 to 10, with 0 = did not interfere and 10 = interfered completely. Lower scores indicated better outcome.
Measured: Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionMar 2011
- Study completionMar 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768755
- Sponsor's protocol ID
- A4061039
- Status last verified
- Oct 2015
- First submitted
- 7 Oct 2008
- Last updated
- 28 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.
PubMed 24766732
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study Of Cisplatin/Pemetrexed With Or Without Axitinib (AG-013736) As First-Line Treatment For Patients With Non-Squamous Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00768755
- Acronym / sponsor ID
- A4061039
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- non-squamous NSCLC, axitinib, pemetrexed/cisplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Posted 30 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AG-013736 (axitinib) in combination with cisplatin and pemetrexed will be evaluated as first-line treatment of patients with locally advanced, recurrent, or metastatic non-squamous, non small cell lung cancer (NSCLC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: axitinibAxitinib (continuous) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
| II | Experimental | Drug: axitinibAxitinib (modified) + Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
| III | Active comparator | Drug: chemotherapypemetrexed and cisplatin |
| IV | Experimental | Drug: axitinibAxitinib interrupted before each chemo cycle (Pemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles followed by axitinib maintenance |
| V | Active comparator | Drug: chemotherapypemetrexed and cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed diagnosis of adeno-, large cell or bronchioalveolar non-small cell lung cancer
- Cytologic specimens for diagnosis or for cell type classification must have been obtained from bronchial brushings or washings or from needle aspiration of a defined lesion. Sputum cytology alone will not be acceptable for diagnosis or for cell type classification.
- Patients with mixed NSCLC with predominantly squamous cell carcinoma should be classified as squamous and thus do not qualify for this study.
- Stage IIIB with malignant effusion (with cytologic confirmation of malignant pleural or pericardial effusion), Stage IV, or recurrent disease after definitive loco-regional therapy.
- Candidate for primary treatment with cisplatin and pemetrexed
Key exclusion criteria (5 listed)
- Any histological/cytological evidence of predominantly squamous NSCLC.
- Small cell or carcinoid lung cancer patients are also ineligible.
- NSCLC that cannot be classified as one of the eligible histologies (adenocarcinoma, large cell or bronchioalveolar).
- Prior systemic therapy for Stage IIIB (with malignant effusion), Stage IV, or recurrent NSCLC. (Prior treatment with systemic therapy as adjuvant chemotherapy or in conjunction with radiotherapy for Stage II or III NSCLC is permitted if the last dose of chemotherapy was completed 12 months or more prior to randomization).
- Prior treatment with a VEGF or VEGFR inhibitor.
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 |
|---|---|---|
| axitinibAlso: AG-0137365mg BID po up to max 10mg BID po | Drug | I |
| axitinibAlso: AG-0137365mg BID po up to max 10mg BID po paused for 3 days before each cycle of concomitant chemotherapy | Drug | II |
| chemotherapyAlso: alimtaPemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles | Drug | III |
| axitinib5mg BID po up to max 10mg BID po paused before each concomitant chemotherapy | Drug | IV |
| chemotherapyAlso: alimtaPemetrexed(500mg/m2)/Cisplatin(75mg/m2) x max 6 cycles | Drug | V |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Time in months from the date of randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus minus the date of randomization plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]); death was determined from AE data (where the outcome was "Death") or from the end of study data.
5 secondary outcomes
Overall Survival (OS)
Time frame: Baseline until death or collected bimonthly following discontinuation of study treatment until at least 1 year after randomization of the last participant
Percentage of Participants With Objective Response (OR)
Time frame: Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Duration of Response (DR)
Time frame: Phase 2 baseline until the date of first documented progression or discontinuation from the study due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Severity Score
Time frame: Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and end of treatment (EOT)
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Symptom Interference Score
Time frame: Phase 2 baseline (Cycle1/Day1), Cycle1/Day8, then Day 1 and 8 of each cycle of chemotherapy (C) up to CycleC6, Day 1 of each cycle of single-agent phase (A) up to CycleA8 and EOT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24766732Belani CP, Yamamoto N, Bondarenko IM, Poltoratskiy A, Novello S, Tang J, Bycott P, Niethammer AG, Ingrosso A, Kim S, Scagliotti GV. Randomized phase II study of pemetrexed/cisplatin with or without axitinib for non-squamous non-small-cell lung cancer. BMC Cancer. 2014 Apr 25;14:290. doi: 10.1186/1471-2407-14-290.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
52 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing axitinib and chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 52 sites in 11 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 5 inclusion and 5 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 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in United States, Poland, United Kingdom, Spain, Russia and 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 30 Mar 2012). 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?
Progression-Free Survival (PFS) (time frame: Phase 2 baseline until the date of first documented progression or death due to any cause or initiation of subsequent anticancer therapy, assessed every 6 weeks up to 84 weeks). 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 NCT00768755, 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 Oct 2015.