Non-Small Cell Lung CancerPhase 3NCT00789373

A Study of Induction and Maintenance Treatment of Advanced Non-squamous Non-Small Cell Lung Cancer

A Phase 3 study testing Pemetrexed and Cisplatin in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 68 sites in 15 countries.

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

This study will compare progression-free survival in patients with advanced non-squamous non-small cell lung cancer. Patients who do not progress following 4 cycles of induction treatment with pemetrexed and cisplatin will be randomized 2:1 to receive either maintenance pemetrexed or placebo. 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?: Pemetrexed and Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 939 participants
Where: 68 sitesin 15 countries
Study dates: Nov 2008to Nov 2017
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

You must sign an informed consent document for clinical research.
You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.
Your test results assessing the function of your blood forming tissue, kidneys, and liver must be satisfactory.
You must be 18 years of age or older.
Women must be sterile, postmenopausal or on contraception and men must be on contraception or sterile (e.g. post-vasectomy).

Who cannot join

You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer
You cannot have received other investigational drugs within the last 30 days of entering the trial.
You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
You cannot have other serious on-going illnesses including active infections.
You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.
You cannot have had another form of cancer other than superficial basal cell and superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the last 5 years. Patients with a history of low-grade (Gleason score less than or equal to 6) localized prostate cancer will be eligible even if diagnosed less than 5 years ago.

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You cannot have known central nervous system (CNS) metastases, other than treated, stable brain metastasis.
You cannot be receiving nor have received any prior systemic anticancer therapy for lung cancer (including chemotherapy given after surgery in early-stage treatment).
You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
You cannot have received a recent (within 30 days) or are receiving a yellow fever vaccination.
You are unable to stop taking more than 1.3 grams of aspirin on a daily basis or other non-steroidal anti-inflammatory drugs (NSAIDs).
You are unable or unwilling to take folic acid, injections of vitamin B12, or corticosteroids.
You cannot be pregnant or breastfeeding.
Inclusion criteria at Randomization for the Maintenance Phase:
You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
You must have documented radiographic evidence of a tumor response of complete response (CR), partial response (PR), or stable disease (SD) according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. This response does not have to be confirmed in order for the patient to be randomized to the maintenance phase.

Trial locations and contacts

68 sites in 15 countries.

Country

City, postcode or hospital

68 sites in 15 countries

Italy9 sites

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Avellino, 83100
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Aviano, 33081
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Genova, 16132
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Lido di Camaiore, 55043
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Monza, 20052
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Pisa, 56100
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Reggio Emilia, 42100
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Rome, 00149
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Udine, 33100

Other trials in Italy

France7 sites

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Avignon, 84082
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Dijon, 21034
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Le Mans, 72037
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Montpellier, F-34295
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Nantes, 44202
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Paris, 75015
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Vandœuvre-lès-Nancy, 54511

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Belgium6 sites

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Aalst, 9300
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Brussels, 1200
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Genk, 3600
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Gilly, 6060
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Liège, 4000
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Sint-Niklaas, 9100

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Germany6 sites

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Frankfurt, 60596
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Gerlingen, 70839
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Großhansdorf, D-22927
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Hamburg, D-20251
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Heidelberg, 69126
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Ulm, 89075

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India5 sites

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Bangalore, 560 078
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Bhopal, 462001
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Madurai, 625020
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Mumbai, 400 012
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Patna, 800 014

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Spain5 sites

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Manresa, 308243
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Sabadell, 08208
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Seville, 41013
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Valencia, 46017
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Zaragoza, 50009

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Finland4 sites

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Espoo, 02740
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Helsinki, 00290
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Tampere, 33520
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Turku, 20520

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Greece4 sites

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Athens
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Chania, 73300
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Neo Faliro, 18547
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Pátrai, 26500

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Netherlands4 sites

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Ede, 6716 RP
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Groningen, 9728 NT
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Harderwijk, 3844 DG
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Heerlen, 6419 PC

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United Kingdom4 sites

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Aberdeen, Scotland, AB25 2ZN
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Birmingham, West Midlands, B15 2TH
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Guildford, Surrey, GU2 7XX
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Newcastle, NE7 7DN

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Australia3 sites

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Adelaide, South Australia, 5000
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Frankston, Victoria, 3199
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Wendouree, Victoria, 3355

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Portugal3 sites

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Coimbra, 3040-853
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Lisbon, 1099-035
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Vila Franca de Xira, 4434-502

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Romania3 sites

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Bucharest, 022328
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Cluj-Napoca, 3400
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Oradea, 3700

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Turkey (Türkiye)3 sites

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Bornova, 35100
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Sihhiye, 06100
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Zeytinburnu, 034760

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Poland2 sites

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Poznan, 60-569
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Warsaw, 02-781

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About this study

Official title: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.

Conditions: Non-Small Cell Lung Cancer
Being tested: Pemetrexed, Cisplatin, Placebo, Best Supportive Care
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.

PemetrexedDrug
Also called Alimta, LY231514
Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles
CisplatinDrug
Induction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles
PlaceboDrug
Maintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation
PemetrexedDrug
Also called Alimta, LY231514
Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.
Best Supportive CareOther
Best Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).

Study groups in NCT00789373
Study group	Role	What they receive
pemetrexed + cisplatin followed by pemetrexed	Experimental	pemetrexed plus cisplatin followed by pemetrexed plus best supportive care Receives: Drug: Pemetrexed; Drug: Cisplatin; Other: Best Supportive Care
pemetrexed + cisplatin followed by placebo	Placebo comparator	pemetrexed plus cisplatin followed by placebo plus best supportive care Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Placebo; Other: Best Supportive Care

What is being measured

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

Investigator-assessed Objective Progression-free Survival (PFS)
Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
Measured: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)

Secondary outcomes (9)

Independently-assessed Objective Progression-free Survival (PFS)
To further evaluate the robustness of the PFS analysis, Lilly established an independent review of PFS to assess the potential for investigator bias in the determination of objective PD. PFS was measured from the date of randomization to the first date of objectively determined PD or death. For patients alive as of the data cutoff date and who did not have PD, PFS was censored at the date of the last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.
Measured: Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
Overall Survival (OS)
OS is the duration from enrollment to death. For patients who are alive, OS is censored at the last contact.
Measured: Date of randomization to the date of death from any cause up to 39.5 months
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
The EQ-5D is a generic instrument that describes health status in 5 attributes (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) using a three level scale (no problem, some problems, and major problems). These combinations of attributes are converted into a weighted health-state Index Score according to the United Kingdom (UK) population-based algorithm. The possible values for the Index Score range from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
Measured: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
Patients indicate their present health state through completion of the VAS. Possible scores range from 0 (worst imaginable health state) to 100 (best imaginable health state).
Measured: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)
Measured: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase
A summary of non-serious AEs is located in the Reported Adverse Event Module.
Measured: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Serious Adverse Events During Maintenance Phase
A summary of serious adverse events is located in the Reported Adverse Event Module.
Measured: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off
Analysis for combined phases was not performed since response was calculated separately for each phase of study. Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response(PR)is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease(PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease(SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD.
Measured: Baseline to date of measured progressive disease (up to 19.3 months)
Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response (CR)=disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) is at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD)=no change or small changes that do not meet the above criteria for CR, PR, or PD. Response Rate = (CR+PR)/Participants in Arm*100. Disease Control Rate=(CR+PR+SD)/Number of Participants in Arm*100.
Measured: Date of randomization to date of measured PD (up to 19.3 months)

Timeline

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

Nov 2008Nov 2017

First posted11 Nov 2008 (estimated)
Study startNov 2008
Primary completionJun 2010
Study completionNov 2017

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 (8)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: 939 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789373
Sponsor's protocol ID: 12560
Other IDs: H3E-EW-S124, CTRI/2009/091/000113
Status last verified: Feb 2018
First submitted: 10 Nov 2008
Last updated: 14 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.
PubMed 29424248
Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.
PubMed 25104617
Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.
PubMed 24419418
Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
PubMed 23835707
Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.
PubMed 23328269
Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.
PubMed 23059776
Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
PubMed 22341744
Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.
PubMed 20211022

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

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All Non-Small Cell Lung Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment With Pemetrexed + Cisplatin for Advanced Non-squamous Non-Small Cell Lung Cancer.
ClinicalTrials.gov ID: NCT00789373
Acronym / sponsor ID: 12560
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 939 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Jun 2010 (actual)
Study completion: Nov 2017 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 18 Jul 2011

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
pemetrexed + cisplatin followed by pemetrexed	Experimental	Drug: Pemetrexed, Drug: Cisplatin, Other: Best Supportive Carepemetrexed plus cisplatin followed by pemetrexed plus best supportive care
pemetrexed + cisplatin followed by placebo	Placebo comparator	Drug: Pemetrexed, Drug: Cisplatin, Drug: Placebo, Other: Best Supportive Carepemetrexed plus cisplatin followed by placebo plus best supportive care

Who may qualify

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

Key inclusion criteria (8 listed)

You must sign an informed consent document for clinical research.
You must have Stage IIIB or IV nonsquamous Non-Small Cell Lung Cancer.
You must at least be able to be physically mobile, take care of yourself, and must be up and about and able to perform light activities such as light housework or office work.
You are allowed to have had prior radiation therapy as long as it was not to more than 25% of the bone marrow and did not include the whole pelvis. Thoracic radiation must be completed more than 30 days before the study. You must be recovered from the toxic effects (except hair loss).
You must have at least 1 measurable tumor lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated by computed tomography (CT) Scan.

Key exclusion criteria (16 listed)

You cannot have squamous cell and/or mixed small cell, non-small cell lung cancer
You cannot have received other investigational drugs within the last 30 days of entering the trial.
You cannot have previously completed or withdrawn from this study or any other study investigating pemetrexed.
You cannot have other serious on-going illnesses including active infections.
You cannot have a serious cardiac condition, such as a heart attack, angina, or heart disease within 6 months of entering the trial.

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
PemetrexedAlso: Alimta, LY231514Induction therapy: 500 mg/m^2, intravenous (IV), on Day 1 of each 21-day cycle for 4 cycles	Drug	pemetrexed + cisplatin followed by pemetrexed, pemetrexed + cisplatin followed by placebo
CisplatinInduction therapy: Cisplatin: 75 mg/m^2, IV, on Day 1 of each 21-day cycle for 4 cycles	Drug	pemetrexed + cisplatin followed by pemetrexed, pemetrexed + cisplatin followed by placebo
PlaceboMaintenance therapy: Normal saline (0.9% sodium chloride) administered IV on Day 1 every 21-day cycle until progressive disease or treatment discontinuation	Drug	pemetrexed + cisplatin followed by placebo
PemetrexedAlso: Alimta, LY231514Maintenance therapy: 500 mg/m^2, IV, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation.	Drug	pemetrexed + cisplatin followed by pemetrexed
Best Supportive CareBest Supportive Care is treatment given with the intent to maximize quality of life. Best Supportive Care excludes any treatment in which the goal is to cure or slow the progression of the study disease. Patients will receive Best Supportive Care as judged by their treating physician. Those therapies considered acceptable include, but are not limited to, palliative radiation to extrathoracic structures, antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support (enteral or parenteral).	Other	pemetrexed + cisplatin followed by pemetrexed, pemetrexed + cisplatin followed by placebo

Primary outcome

Investigator-assessed Objective Progression-free Survival (PFS)
Time frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)
Investigator-assessed objective PFS was measured from the date of randomization to the first date of objectively determined progressive disease (PD) or death from any cause. For patients not known to have died as of the data cutoff date and who did not have objective PD, PFS was censored at the date of last objective tumor assessment. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. PD = 20% increase in sum of longest diameter of target lesions.

9 secondary outcomes

Independently-assessed Objective Progression-free Survival (PFS)
Time frame: Date of randomization to first date of measured PD or date of death from any cause (up to 19.3 months)
Overall Survival (OS)
Time frame: Date of randomization to the date of death from any cause up to 39.5 months
Change From Baseline in the EuroQol Instrument (EQ-5D) Index Score
Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Change From Baseline in EuroQol Instrument (EQ-5D) Visual Analog Scale (VAS)
Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With Hospitalizations Due to Adverse Events or Requiring Transfusion (Resource Utilization)
Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 19.3 months)
Percentage of Participants With a Non-Serious Adverse Event (AE) During Maintenance Phase
Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Serious Adverse Events During Maintenance Phase
Time frame: Baseline randomization through 30-day post-discontinuation visit (up to 49.7 months)
Percentage of Participants With Objective Tumor Response (Response Rate) During Maintenance Phase of Study up to Primary Data Cut-Off
Time frame: Baseline to date of measured progressive disease (up to 19.3 months)
Percentage of Participants With Independently-Assessed Objective Tumor Response (Response Rate) During Maintenance Phase Up to Primary Data Cut-Off
Time frame: Date of randomization to date of measured PD (up to 19.3 months)

Results and safety

Results posted to the registry on 18 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Induction Pemetrexed + Cisplatin	939	540
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	0	0
Pemetrexed + Cisplatin Followed by Placebo	0	0

Primary outcome: Investigator-assessed Objective Progression-free Survival (PFS)

Time frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months). Median (95% Confidence Interval). Unit: months

Measure	Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed n = 359	Pemetrexed + Cisplatin Followed by Placebo n = 180
Value	4.11 (3.15 to 4.57)	2.83 (2.60 to 3.12)

Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed vs Pemetrexed + Cisplatin Followed by Placebo: Hazard Ratio (HR): 0.62 (95% CI 0.49 to 0.79), p = 0.00006, Log Rank

Population analysed: All randomized participants

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From start of study up to approximately 108 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Induction Pemetrexed + Cisplatin	257 of 939 (27.4%)	759 of 939 (80.8%)	Not reported
Pemetrexed + Cisplatin Followed by Maintenance Pemetrexed	94 of 359 (26.2%)	287 of 359 (79.9%)	Not reported
Pemetrexed + Cisplatin Followed by Placebo	36 of 180 (20%)	117 of 180 (65%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29424248Middleton G, Gridelli C, De Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Visseren-Grul CM, San Antonio B, John WJ, Zimmermann AH, Chouaki N, Paz-Ares L. Evaluation of changes in renal function in PARAMOUNT: a phase III study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Curr Med Res Opin. 2018 May;34(5):865-871. doi: 10.1080/03007995.2018.1439462. Epub 2018 Mar 27.
Derived from this study: PubMed 25104617Pujol JL, Paz-Ares L, de Marinis F, Dediu M, Thomas M, Bidoli P, Corral J, San Antonio B, Chouaki N, John W, Zimmermann A, Visseren-Grul C, Gridelli C. Long-term and low-grade safety results of a phase III study (PARAMOUNT): maintenance pemetrexed plus best supportive care versus placebo plus best supportive care immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2014 Nov;15(6):418-25. doi: 10.1016/j.cllc.2014.06.007. Epub 2014 Jun 21.
Derived from this study: PubMed 24419418Reck M, Paz-Ares LG, de Marinis F, Molinier O, Sahoo TP, Laack E, John W, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Descriptive subgroup analyses of final overall survival for the phase III study of maintenance pemetrexed versus placebo following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2014 Feb;9(2):205-13. doi: 10.1097/JTO.0000000000000076.
Derived from this study: PubMed 23835707Paz-Ares LG, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Aug 10;31(23):2895-902. doi: 10.1200/JCO.2012.47.1102. Epub 2013 Jul 8.
Derived from this study: PubMed 23328269Zeng X, Peng L, Li J, Chen G, Tan C, Wang S, Wan X, Ouyang L, Zhao Z. Cost-effectiveness of continuation maintenance pemetrexed after cisplatin and pemetrexed chemotherapy for advanced nonsquamous non-small-cell lung cancer: estimates from the perspective of the Chinese health care system. Clin Ther. 2013 Jan;35(1):54-65. doi: 10.1016/j.clinthera.2012.12.013.
Derived from this study: PubMed 23059776Gridelli C, de Marinis F, Pujol JL, Reck M, Ramlau R, Parente B, Pieters T, Middleton G, Corral J, Winfree K, Melemed S, Zimmermann A, John W, Beyrer J, Chouaki N, Visseren-Grul C, Paz-Ares LG. Safety, resource use, and quality of life in paramount: a phase III study of maintenance pemetrexed versus placebo after induction pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2012 Nov;7(11):1713-21. doi: 10.1097/JTO.0b013e318267cf84.
Derived from this study: PubMed 22341744Paz-Ares L, de Marinis F, Dediu M, Thomas M, Pujol JL, Bidoli P, Molinier O, Sahoo TP, Laack E, Reck M, Corral J, Melemed S, John W, Chouaki N, Zimmermann AH, Visseren-Grul C, Gridelli C. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012 Mar;13(3):247-55. doi: 10.1016/S1470-2045(12)70063-3. Epub 2012 Feb 16.
Derived from this study: PubMed 20211022Paz-Ares LG, Altug S, Vaury AT, Jaime JC, Russo F, Visseren-Grul C. Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer. BMC Cancer. 2010 Mar 8;10:85. doi: 10.1186/1471-2407-10-85.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

68 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed and Cisplatin in people with Non-Small Cell Lung Cancer, run by Eli Lilly and Company at 68 sites in 15 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 8 inclusion and 16 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 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Italy, France, Belgium, Germany, India and 10 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 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 18 Jul 2011). 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?

Investigator-assessed Objective Progression-free Survival (PFS) (time frame: Date of randomization to the date of measured PD or date of death from any cause (up to 19.3 months)). 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 NCT00789373, which also lists 8 linked publications.

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 14 Dec 2018.