Non Small Cell Lung CancerPhase 3PROCLAIMNCT00686959

Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer

A Phase 3 study testing Pemetrexed, Cisplatin and Etoposide in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 133 sites in 19 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 the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology. 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, Cisplatin and Etoposide
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 598 participants
Where: 133 sitesin 19 countries
Study dates: Sep 2008to Nov 2014
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

Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
Participants must be 18 years of age or older
Participants must have lost no more than 10% of their body weight in the previous 3 months
Women must be sterile, postmenopausal, or on contraception, and men must be sterile or on contraception
Participants' test results assessing the function of their blood forming tissue, kidneys, liver, and lungs must be satisfactory
Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be entered into this study. However, participants with cervical nodes are not permitted. The upper border of supraclavicular nodes must not extend above the upper border of the lateral end of the clavicle, extended medially.

Who cannot join

Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
Participants who have received other investigational drugs within the last 30 days
Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents
Participants who have diseases considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumors

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Participants who had prior thoracic radiation. However, other prior radiotherapy is allowed. Participants must have recovered from the toxic effects of the treatment prior to study enrollment. Participants may not have received whole pelvis radiation or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been completed at least 30 days prior to study treatment.
Participants who have a radiation treatment plan that would expose more than 35% of the volume of their lung to 20 gray (Gy) or more of radiation
Participants who have concurrent cancer from another primary site requiring treatment of any kind within the past 5 years. Exemptions to this will be permitted on a case-by-case basis after prior approval by the Sponsor physician or designate if the investigator believes the participant's risk of recurrence and death is very low. Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is allowed. Participants with recurrence of a previously resected lung cancer or who have a second primary lung cancer are ineligible.

Trial locations and contacts

133 sites in 19 countries.

Country

City, postcode or hospital

133 sites in 19 countries

United States50 sites

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Ann Arbor, Michigan, 48106
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Athens, Georgia, 30607
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Bedford, Texas, 76022
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Birmingham, Alabama, 35249
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Burlington, Vermont, 05405
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Charleston, South Carolina, 29425
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45242
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Columbia, Maryland, 21044
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Dallas, Texas, 75246
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Duarte, California, 91010
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Evansville, Indiana, 47713
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Fairhaven, Massachusetts, 02719
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Fargo, North Dakota, 58122
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Fayetteville, Arkansas, 72703
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Fountain Valley, California, 92708
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Hollywood, Florida, 33021
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Indianapolis, Indiana, 46237
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Kansas City, Missouri, 64132
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La Jolla, California, 92093
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Longview, Texas, 75601
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Louisville, Kentucky, 40402
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Madison, Wisconsin, 53792
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Marietta, Georgia, 30060
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Memphis, Tennessee, 38119
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Minneapolis, Minnesota, 55455
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Morgantown, West Virginia, 26506
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Nashville, Tennessee, 37203
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New Albany, Indiana, 47150
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New Haven, Connecticut, 06520
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New York, New York, 10065
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Odessa, Texas, 79761
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Quincy, Illinois, 62301
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San Marcos, Texas, 78666
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Scottsdale, Arizona, 85259
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Sherman, Texas, 75090
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Spokane, Washington, 99220
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St Louis, Missouri, 63110
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Sugar Land, Texas, 77479
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Tampa, Florida, 33612
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The Bronx, New York, 10467
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The Woodlands, Texas, 77380
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Thomasville, Georgia, 31792
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Tucson, Arizona, 85704
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Vancouver, Washington, 98684
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West Palm Beach, Florida, 33401
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Westwood, Kansas, 66205
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Wichita, Kansas, 67214
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Wichita Falls, Texas, 76310

Other trials in United States

Germany11 sites

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Cologne, 51109
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Erlangen, 91054
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Frankfurt, 60596
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Hanover, 30625
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Hemer, 58675
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Immenhausen, 34376
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Mainz, 55131
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Mannheim, 68167
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Oldenburg, 26121
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Rheine, 48431
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Ulm, 89081

Other trials in Germany

Belgium8 sites

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Antwerp, 2020
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Edegem, 2650
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Ghent, 9000
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Gilly, 6060
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Haine-St.- Paul, 7100
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Leuven, 3000
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Namur, 5000
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Turnhout, 2300

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Spain8 sites

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Alicante, 03010
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Badalona, 08915
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Elche, 03202
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L'Hospitalet de Llobregat, 08908
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Madrid, 28050
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Majadahonda, 28222
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Pamplona, 31008
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Terrassa, 08227

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India7 sites

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Bangalore, 560 027
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Hyderabaad, 500024
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Jaipur, 302016
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Kolkata, 700029
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Madurai, 625020
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Mumbai, 400053
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Trivandrum, 695011

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China6 sites

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Beijing, 100021
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Guangzhou, 510060
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Jinan
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Shanghai, 200030
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Sichuan, 610041
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Wuhan, 430030

Other trials in China

Brazil5 sites

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Barretos, 14784700
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Curitiba, 81520-060
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Porto Alegre, 90610-970
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Rio de Janeiro, 20231-050
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São Paulo, 01246000

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Canada5 sites

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Edmonton, Alberta, T6G 1Z2
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London, Ontario, N6A 4L6
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Montreal, Quebec, H3G 1A4
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Newmarket, Ontario, L3Y2P9
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Toronto, Ontario, M5G 2M9

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Turkey (Türkiye)5 sites

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Fatih, 34098
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Gaziantep, 27310
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Izmir, 35100
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Melikgazi, 38039
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Umuttepe, 41380

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France4 sites

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Bayonne, 64100
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Lille, 59020
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Paris, 75475
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Pierre-Bénite, 69495

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Taiwan4 sites

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Kaohsiung City, 813
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Kuei Shan Hsiang, 33305
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Taichung, 40705
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Taipei, 100

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United Kingdom4 sites

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Edgbaston, Birmingham, B15 2TH
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Edinburgh, Scotland, EH4 2XU
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London, Greater London, W6 8RF
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Manchester, United Kingdom, M20 4BX

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Australia3 sites

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Frankston, Victoria, 3199
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Launceston, Tasmania, 7250
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Wollongong, New South Wales, 2500

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Netherlands3 sites

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's-Hertogenbosch, 5223 GZ
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Amsterdam, 1081 HV
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Breda, 4818 CK

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Portugal3 sites

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Lisbon, 1649-035
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Santa Maria da Feira, 4520-211
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Vila Franca de Xira, 4434-502

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South Korea3 sites

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Incheon, 405-760
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Seoul, 139-706
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Suwon, 442-723

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Greece2 sites

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Athens, 18537
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Pátrai, 26500

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Argentina1 site

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Buenos Aires, C1188AAF

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Ireland1 site

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Dublin

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About this study

Official title: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology

This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Conditions: Non Small Cell Lung Cancer
Being tested: Pemetrexed, Cisplatin, Etoposide, Vinorelbine, Paclitaxel
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
infusion over 10 minutes
CisplatinDrug
infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines
EtoposideDrug
administered per local practice guidelines over a minimum of 30 minutes
VinorelbineDrug
administered over 6-10 minutes infusion per local practice guidelines
PaclitaxelDrug
administered as a 3-hour infusion
CarboplatinDrug
administered per local practice guidelines over 30 minutes
Thoracic Radiation Therapy (TRT)Radiation

Study groups in NCT00686959
Study group	Role	What they receive
Arm A: Pemetrexed + Cisplatin and TRT	Experimental	Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles Receives: Drug: Pemetrexed; Drug: Cisplatin; Radiation: Thoracic Radiation Therapy (TRT)
Arm B: Etoposide + Cisplatin and TRT	Active comparator	Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22 Receives: Drug: Cisplatin; Drug: Etoposide; Drug: Vinorelbine; Drug: Paclitaxel; Drug: Carboplatin; Radiation: Thoracic Radiation Therapy (TRT)

What is being measured

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

Overall Survival
Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.
Measured: Baseline to Date of Death from Any Cause (Up to 71.4 Months)

Secondary outcomes (5)

Progression-free Survival (PFS)
Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates.
Measured: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
Measured: Baseline to Measured Progressive Disease (Up to 7 Months)
Survival Rates at 1, 2, and 3 Years
The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates.
Measured: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
First Site of Disease Failure in Terms of Relapse
The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category.
Measured: Baseline to Relapse (Up to 66.6 Months)
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made.
Measured: Baseline through 30 Days Post Study

Timeline

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

Sep 2008Nov 2014

First posted30 May 2008 (estimated)
Study startSep 2008
Primary completionOct 2014
Study completionNov 2014

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 (2)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: None (open label)
Enrolment: 598 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00686959
Sponsor's protocol ID: 11514
Other IDs: H3E-MC-JMIG
Acronym: PROCLAIM
Status last verified: May 2016
First submitted: 28 May 2008
Last updated: 28 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.
PubMed 31125266
Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.
PubMed 29976505

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?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Non-Small Cell Lung Cancer (NSCLC)
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Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other Than Predominantly Squamous Cell Histology
ClinicalTrials.gov ID: NCT00686959
Acronym / sponsor ID: PROCLAIM / 11514
Conditions: Non Small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 598 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 30 May 2008 (estimated)
Results: Posted 26 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will compare the overall survival of participants with locally-advanced, Stage III Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm A: Pemetrexed + Cisplatin and TRT	Experimental	Drug: Pemetrexed, Drug: Cisplatin, Radiation: Thoracic Radiation Therapy (TRT)Participants were treated with Pemetrexed plus Cisplatin and concurrent thoracic radiation therapy (TRT) ("Concurrent Phase") for three 21-day cycles, followed by a 3-5 week "Recovery Period," then treated with consolidation chemotherapy with pemetrexed ("Consolidation Phase") for up to four 21-day cycles Concurrent Phase: Pemetrexed: 500 milligrams per meter squared (mg/m^2), intravenous (IV) on Day 1 of each 21-day cycle for 3 cycles. Cisplatin: 75 mg/m^2, IV on Day 1 of each 21-day cycle x 3 cycles. TRT: Beginning on Day 1 of chemotherapy, once daily fractions (2 Gray [Gy] per day), 5 days a week for 6 weeks and 3 days to target 66 Gy in 33 fractions. Consolidation Phase: Pemetrexed: 500 mg/m^2, IV on Day 1 of each 21-day cycle up to 4 cycles
Arm B: Etoposide + Cisplatin and TRT	Active comparator	Drug: Cisplatin, Drug: Etoposide, Drug: Vinorelbine, Drug: Paclitaxel, Drug: Carboplatin, Radiation: Thoracic Radiation Therapy (TRT)Participants were treated with Etoposide plus Cisplatin and concurrent TRT ("Concurrent Phase") for two 28-day cycles, followed by a 3-5 week "Recovery Period," then received consolidation treatment with cytotoxic chemotherapy of choice ("Consolidation Phase") for up to 2 cycles Concurrent Phase: Etoposide/Cisplatin (28-day cycle); Etoposide: 50 mg/m^2, IV on Days 1 to 5 and Days 29 to 33 and Cisplatin: 50 mg/m^2, IV on Days1, 8, 29, and 36 Consolidation Phase options: Option 1: Continue the same treatment plan as Concurrent Phase Option 2: Vinorelbine/Cisplatin (21-day cycle); Vinorelbine: 30 mg/m^2, IV on Days 1, 8, 22, and 29; Cisplatin: 75 mg/m^2, IV on Days 1 and 22 Option 3: Paclitaxel/Carboplatin (21-day cycle); Paclitaxel: 200 mg/m^2, IV, on Days 1 and 22; Carboplatin: area under the concentration-time curve (AUC) = 6 (Carboplatin dosing based on calculated creatinine clearance), IV on Days 1 and 22

Who may qualify

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

Key inclusion criteria (8 listed)

Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type
Participants must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on computerized tomography (CT) scan
Participants must be physically mobile, take care of themselves and must be up and about and able to perform light activities, such as light housework or office work
Participants must be 18 years of age or older
Participants must have lost no more than 10% of their body weight in the previous 3 months

Key exclusion criteria (9 listed)

Participants cannot have other on-going (uncontrolled) illnesses, including active infections, recent heart problems, or psychiatric illnesses
Participants who are unable to take vitamins (including injections of vitamin B12) or oral cortisone medication
Participants who have had a heart attack (myocardial infarction) or other cardiac issues within 6 months of the trial
Participants who have received other investigational drugs within the last 30 days
Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily basis or non-steroidal anti-inflammatory agents

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, LY231514infusion over 10 minutes	Drug	Arm A: Pemetrexed + Cisplatin and TRT
Cisplatininfusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines	Drug	Arm A: Pemetrexed + Cisplatin and TRT, Arm B: Etoposide + Cisplatin and TRT
Etoposideadministered per local practice guidelines over a minimum of 30 minutes	Drug	Arm B: Etoposide + Cisplatin and TRT
Vinorelbineadministered over 6-10 minutes infusion per local practice guidelines	Drug	Arm B: Etoposide + Cisplatin and TRT
Paclitaxeladministered as a 3-hour infusion	Drug	Arm B: Etoposide + Cisplatin and TRT
Carboplatinadministered per local practice guidelines over 30 minutes	Drug	Arm B: Etoposide + Cisplatin and TRT
Thoracic Radiation Therapy (TRT)	Radiation	Arm A: Pemetrexed + Cisplatin and TRT, Arm B: Etoposide + Cisplatin and TRT

Primary outcome

Overall Survival
Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates.

5 secondary outcomes

Progression-free Survival (PFS)
Time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)
Objective Response Rate (Complete Response [CR] + Partial Response [PR])
Time frame: Baseline to Measured Progressive Disease (Up to 7 Months)
Survival Rates at 1, 2, and 3 Years
Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months)
First Site of Disease Failure in Terms of Relapse
Time frame: Baseline to Relapse (Up to 66.6 Months)
Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
Time frame: Baseline through 30 Days Post Study

Results and safety

Results posted to the registry on 26 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm A: Pemetrexed + Cisplatin and TRT	301	177
Arm B: Etoposide + Cisplatin and TRT	297	180

Primary outcome: Overall Survival

Time frame: Baseline to Date of Death from Any Cause (Up to 71.4 Months). Median (95% Confidence Interval). Unit: months

Measure	Arm A: Pemetrexed + Cisplatin and TRT n = 301	Arm B: Etoposide + Cisplatin and TRT n = 297
Value	26.81 (20.40 to 30.92)	24.97 (22.18 to 29.83)

Arm A: Pemetrexed + Cisplatin and TRT vs Arm B: Etoposide + Cisplatin and TRT: Hazard Ratio (HR): 0.98 (95% CI 0.79 to 1.20), p = 0.831, Log Rank

Population analysed: All randomized participants. Arm A had 124 participants censored and Arm B had 117 participants censored.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm A:	134 of 283 (47.3%)	279 of 283 (98.6%)	Not reported
Arm B: Etoposide + Cisplatin and TRT	145 of 272 (53.3%)	269 of 272 (98.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31125266Govindan R, Senan S, Dickgreber N, Provencio M, Wu YL, Syrigos K, Parente B, Wilson M, Ziemiecki R, Chouaki N, Hossain A, San Antonio B, Winfree K, Vokes EE. Healthcare resource utilization and associated cost analysis of the PROCLAIM study in patients with stage III non-small-cell lung cancer. Curr Med Res Opin. 2019 Oct;35(10):1761-1767. doi: 10.1080/03007995.2019.1623185. Epub 2019 Jul 5.
Derived from this study: PubMed 29976505Brade AM, Wenz F, Koppe F, Lievens Y, San Antonio B, Iscoe NA, Hossain A, Chouaki N, Senan S. Radiation Therapy Quality Assurance (RTQA) of Concurrent Chemoradiation Therapy for Locally Advanced Non-Small Cell Lung Cancer in the PROCLAIM Phase 3 Trial. Int J Radiat Oncol Biol Phys. 2018 Jul 15;101(4):927-934. doi: 10.1016/j.ijrobp.2018.04.015. Epub 2018 Apr 12.
Lilly Clinical Trial RegistryLink 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.

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

133 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pemetrexed, Cisplatin and Etoposide in people with Non Small Cell Lung Cancer, run by Eli Lilly and Company at 133 sites in 19 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 9 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 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, Germany, Belgium, Spain, India and 14 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 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 26 Nov 2015). 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 (time frame: Baseline to Date of Death from Any Cause (Up to 71.4 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 NCT00686959, which also lists 2 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 28 Jun 2016.