Lung Cancer (NSCLC)Phase 3NCT02279732
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and Carboplatin
A Phase 3 study testing Paclitaxel, Carboplatin and Ipilimumab in people with Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 49 sites in 6 countries.
Trial summary
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Paclitaxel, Carboplatin and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 49 sitesin 6 countries
- Study dates
- 13 Oct 2014to 3 May 2018
- Phase
- Phase 3
- 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
- Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
- Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
- At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Who cannot join
- Brain metastases
- Malignant pleural effusion that is recurrent
- Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
China29 sites
Local Institution
Beijing, Beijing Municipality, 100032
Local Institution
Beijing, Beijing Municipality, 100042
Local Institution
Beijing, 100071
Local Institution
Changchun, Jilin, 130012
Local Institution
Changchun, Jilin, 130021
Local Institution
Changsha, Hunan, 410008
Local Institution
Changsha, Hunan
Local Institution
Chengdu, Sichuan, 610041
Local Institution
Chongqing, Chongqing Municipality, 400042
Local Institution
Chongqing, 400038
Local Institution
Fuzhou, Fujian, 350025
Local Institution
Fuzhou
Local Institution
Guangzhou, Guangdong, 510060
Local Institution
Guangzhou, Guangdong, 510080
Local Institution
Guangzhou, Guangdong, 510120
Local Institution
Hangzhou, Zhejiang, 310003
Local Institution
Hangzhou, Zhejiang, 310009
Local Institution
Hangzhou, Zhejiang, 310016
Local Institution
Hangzhou, Zhejiang, 310022
Local Institution
Kunming
Local Institution
Nanjing, Jiangsu, 210000
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Shanghai, Shanghai Municipality, 200025
Local Institution
Shanghai, Shanghai Municipality, 200032
Local Institution
Shanghai, 200030
Local Institution
Shantou, Guangdong, 515041
Local Institution
Xi'an, Shan3xi, 710038
Local Institution
Xi'an, Shan3xi, 710061
Local Institution
Zhengzhou, Henan
Germany6 sites
Local Institution
Berlin, 13125
Local Institution
Halle, 06120
Local Institution
Hamburg, 21075
Local Institution
Leipzig, 04357
Local Institution
Löwenstein, 74245
Local Institution
Mainz, 55131
South Korea6 sites
Local Institution
Cheongju-si, Chungcheonbuk-do, 28644
Local Institution
Hwasun-gun, Jeollanam-do, 58128
Local Institution
Seoul, 03722
Local Institution
Seoul, 05368
Local Institution
Seoul, 06351
Local Institution
Suwon, Gyeonggi-do, 16499
Hungary3 sites
Pulmonologiai Klinika
Budapest, 1125
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza
Deszk, 6772
Torokbalinti Tudogyogyintezet
Törökbálint, 2045
Poland3 sites
Oddzial Onkologiczny
Elblag, 82-300
Oddzial Chemioterapii
Poznan, 60-569
Klinika Nowotworow Pluca i Klatki Piersiowej
Warsaw, 02-781
Singapore2 sites
Local Institution
Singapore, 169610
Local Institution
Singapore, 308433
About this study
Official title: A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Paclitaxel, Carboplatin, Ipilimumab, Placebo
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelBiological
Also called Taxol®, BMS-181339
CarboplatinBiological
Also called Paraplatin®
IpilimumabBiological
Also called MDX-010, BMS-734016
PlaceboOther
0.9% sodium chloride injection, USP, or 5% dextrose injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Carboplatin + Paclitaxel + Ipilimumab | Experimental | Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO)
Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Receives: Biological: Paclitaxel; Biological: Carboplatin; Biological: Ipilimumab |
| Arm 2: Carboplatin + Paclitaxel + Placebo | Experimental | Carboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO
Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Receives: Biological: Paclitaxel; Biological: Carboplatin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Measured: Approximately 43 months post study start
Secondary outcomes (2)
Overall Survival of All Randomized Participants
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
Measured: Approximately 43 months post study start
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
PFS is defined as the time between the date of randomization and the date of progression per mWHO criteria or death, whichever occurs first. A participant who died without reported progression per mWHO criteria was considered to have progressed on the date of death. For those participants who remained alive and had not progressed, PFS was censored on the date of last evaluable tumor assessment. For those participants who remained alive and had no recorded post-baseline tumor assessment, PFS was censored on the day of randomization.
Measured: Approximately 43 months post study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start13 Oct 2014
- Primary completion3 May 2018
- Study completion3 May 2018
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 Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279732
- Sponsor's protocol ID
- CA184-153
- Other IDs
- 2014-002604-25, 2014
- Status last verified
- Jul 2019
- First submitted
- 14 Oct 2014
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Multinational, Phase 3 Trial Comparing the Efficacy of Ipilimumab in Addition to Paclitaxel and Carboplatin Versus Placebo in Addition to Paclitaxel and Carboplatin in Subjects With Stage IV/Recurrent Non-Small Cell Lung Cancer (NSCLC) With Squamous Histology
- ClinicalTrials.gov ID
- NCT02279732
- Acronym / sponsor ID
- CA184-153
- Conditions
- Lung Cancer (NSCLC)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2014 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine whether Ipilimumab plus Paclitaxel and Carboplatin will extend the life of patients with squamous only non small cell lung cancer more than placebo plus Paclitaxel and Carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Carboplatin + Paclitaxel + Ipilimumab | Experimental | Biological: Paclitaxel, Biological: Carboplatin, Biological: IpilimumabPaclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by modified WHO (mWHO) Carboplatin Area Under the Curve (AUC6) IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Ipilimumab 10 mg/kg IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO |
| Arm 2: Carboplatin + Paclitaxel + Placebo | Experimental | Biological: Paclitaxel, Biological: Carboplatin, Other: PlaceboCarboplatin AUC6 IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Paclitaxel 175 mg/m² IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO Placebo IV Solution Every 3 weeks during induction and every 12 weeks during maintenance until disease progression declared by mWHO |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with NSCLC of predominantly squamous histology documented by histology or cytology from brushing, washing or needle aspiration of a defined lesion but not from sputum cytology alone
- Stage IV or Recurrent NSCLC (per the 7th International Association for the Study of Lung Cancer (IASLC) classification)
- At least 1 measurable tumor lesion, as defined by mWHO criteria, that is not located in a previously irradiated area
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
Key exclusion criteria (3 listed)
- Brain metastases
- Malignant pleural effusion that is recurrent
- Documented history of severe autoimmune or immune mediated symptomatic disease that required prolonged (more than 2 months) systemic immunosuppressive (ie, steroids) treatment
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 |
|---|---|---|
| PaclitaxelAlso: Taxol®, BMS-181339 | Biological | Arm 1: Carboplatin + Paclitaxel + Ipilimumab, Arm 2: Carboplatin + Paclitaxel + Placebo |
| CarboplatinAlso: Paraplatin® | Biological | Arm 1: Carboplatin + Paclitaxel + Ipilimumab, Arm 2: Carboplatin + Paclitaxel + Placebo |
| IpilimumabAlso: MDX-010, BMS-734016 | Biological | Arm 1: Carboplatin + Paclitaxel + Ipilimumab |
| Placebo0.9% sodium chloride injection, USP, or 5% dextrose injection | Other | Arm 2: Carboplatin + Paclitaxel + Placebo |
Primary outcome
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy
Time frame: Approximately 43 months post study start
OS is defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored on the last date the participant was known to be alive.
2 secondary outcomes
Overall Survival of All Randomized Participants
Time frame: Approximately 43 months post study start
Progression-free Survival (PFS) Among All Randomized Particiapants Who Received at Least One Dose of Blinded Study Therapy Using Modified World Health Organization (mWHO) Criteria
Time frame: Approximately 43 months post study start
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paclitaxel, Carboplatin and Ipilimumab in people with Lung Cancer (NSCLC), run by Bristol-Myers Squibb at 49 sites in 6 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 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in China, Germany, South Korea, Hungary, Poland and 1 more country. 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 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?
Yes. Results are posted in the registry (first posted 28 Aug 2019). 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?
Overall Survival (OS) of All Randomized Participants Who Received at Least One Dose of Blinded Study Therapy (time frame: Approximately 43 months post study start). 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 28 Aug 2019.