Metastatic Gastric AdenocarcinomaPhase 3RAINFALLNCT02314117

A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach Cancer

A Phase 3 study testing Ramucirumab, Capecitabine and Cisplatin in people with Metastatic Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by Eli Lilly and Company at 135 sites in 20 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

The main purpose of this study is to evaluate the efficacy of ramucirumab, which is a targeted antibody, in combination with capecitabine and cisplatin compared to capecitabine and cisplatin alone in participants with stomach cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
What is being tested?: Ramucirumab, Capecitabine and Cisplatin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 645 participants
Where: 135 sitesin 20 countries
Study dates: 20 Jan 2015to 14 Aug 2020
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

Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
Have adequate organ function.
Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or 5-FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
Have an estimated life expectancy of ≥12 weeks in the judgment of the investigator.

Who cannot join

Participants with adenocarcinoma of the esophagus are excluded.
Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
Have radiation therapy within 14 days prior to randomization.
Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.
Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal tract within 12 weeks prior to randomization.

Show all 18Show fewer

Have experienced any arterial thromboembolic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization.
Have symptomatic congestive heart failure (New York Heart Association II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
Have uncontrolled hypertension prior to initiating study treatment, despite antihypertensive intervention.
Have undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to first dose of study treatment, except if the procedure is minimally invasive (for example, introduction of peripherally inserted central catheter [PICC] line) and the investigator does not anticipate any significant bleeding.
Have a history of gastrointestinal perforation and/or fistulae within 6 months prior to randomization.
Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization.
Have an acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator.
The participant has:
cirrhosis at a level of Child-Pugh B (or worse) or
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis.
Have known allergy or hypersensitivity to any components of study treatment.
Are pregnant or lactating.

Trial locations and contacts

135 sites in 20 countries.

Country

City, postcode or hospital

135 sites in 20 countries

United States25 sites

Emory University
Atlanta, Georgia, 30322
University of Colorado School of Medicine
Aurora, Colorado, 80045
Comprehensive Blood and Cancer Center
Bakersfield, California, 93309
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
UT Southwestern Med Ctr
Dallas, Texas, 75390
Highlands Oncology Group
Fayetteville, Arkansas, 72703
Holy Cross Hospital Inc.
Fort Lauderdale, Florida, 33308
Florida Cancer Specialists
Fort Myers, Florida, 33916
St Jude Medical Center
Fullerton, California, 92835
Baylor College of Medicine
Houston, Texas, 77030
SMO TRIO -Translational Research
Los Angeles, California, 90024
UCLA Medical Center
Los Angeles, California, 90024
SMO Sarah Cannon Research Inst.
Nashville, Tennessee, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, 37203
Yale University School of Medicine
New Haven, Connecticut, 06520-8020
Weill Cornell Medical College
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Illinois CancerCare
Peoria, Illinois, 61615
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Cancer Care Associates Medical Group
Redondo Beach, California, 90277
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401
Central Coast Medical Oncology Corporation
Santa Monica, California, 93454
Florida Cancer Specialists and Research Institute
St. Petersburg, Florida, 33705

Other trials in United States

Japan12 sites

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Chiba, 260-8717
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Fukuoka, 811-1395
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Higashinari-Ku, 537-8511
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Kashiwa, 277 8577
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Kitaadachi-Gun, 362-0806
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Kobe, 650-0047
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Kōtoku, 135-8550
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Nagoya, 464-8681
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Osaka, 558-8558
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Suita-shi, 565-0871
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Sunto-Gun, 411-8777
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Utsunomiya, 320-0834

Other trials in Japan

Canada8 sites

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Montreal, H2L 4M1
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Montreal, H4A 3J1
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Ottawa, K1H 8L6
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Toronto, M4N 3M5
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Toronto, M5B 1W8
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Toronto, M5G 1X5
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Toronto, M5G 2M9
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Vancouver, V5Z 4E6

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Italy8 sites

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Florence, 50134
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Milan, 20133
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Naples, 80131
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Padova, 35128
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Pisa, 56126
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Roma, 00168
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Torrette Di Ancona, 60020
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Udine, 33100

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Mexico8 sites

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Guadalajara, Jalisco, 44200
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Juchitán, 70000
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Mérida, 97138
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México, 06760
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Mexico City, Mexico City, 03310
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Mexico City, 14080
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Oaxaca City, 68000
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San Bernardino, Toluca, 50080

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United Kingdom8 sites

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Aberdeen, AB25 2ZN
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Cambridge, CB2 0QQ
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London, SE1 9RT
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Manchester, M20 4BX
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Merseyside, CH63 4JY
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Nottingham, NG5 1PB
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Sheffield, S10 2SJ
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Sutton, SM2 5PT

Other trials in United Kingdom

France7 sites

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Avignon, 84918
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Clermont-Ferrand, 63003
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Lille, 59037
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Paris, 75015
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Saint-Etienne, 42055
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Saint-Herblain, 44805
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Villejuif, 94805

Other trials in France

Argentina6 sites

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Ciudad Autonoma Buenos Aires, 1093
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La Rioja, 5300
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Rosario, Santa Fe Province, 2000
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Rosario, S2002KDS
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Salta, 4400
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Viedma, Río Negro Province, 8500

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Czechia5 sites

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Brno, 656 53
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Hradec Králové, 500 05
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Olomouc, 775 20
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Prague, 128 08
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Prague, 150 06

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Germany5 sites

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Dresden, 01307
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Frankfurt am Main, 60488
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Hamburg, 20249
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Mannheim, 68167
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München, 81675

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Hungary5 sites

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Budapest, 1097
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Debrecen, 4032
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Gyula, 5700
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Kaposvár, 7400
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Szolnok, 5000

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Israel5 sites

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Haifa, 3525408
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Jerusalem, 9112001
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Petah Tikva, 4941492
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Tel Aviv, 6423906
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Tel Litwinsky, 5265601

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Netherlands5 sites

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Amsterdam, 1066 CX
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Amsterdam, 1105 AZ
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Breda, 4819 EV
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Nieuwegein, 3435 CM
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Sittard - Geleen, 6162 BG

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Russia5 sites

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Arkhangelsk, 163045
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Moscow, 115478
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Saint Petersburg, 194291
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Saint Petersburg, 197758
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Saint Petersburg, 198255

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Spain5 sites

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Barcelona, 08003
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Barcelona, 08035
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Elche, 03202
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Madrid, 28007
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Madrid, 28034

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Belgium4 sites

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Brussels, 1200
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Charleroi, 6000
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Ghent, 9000
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Leuven, 3000

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Poland4 sites

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Gdansk, 80-219
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Lodz, 93-513
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Poznan, 61-485
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Warsaw, 04-125

Other trials in Poland

Puerto Rico4 sites

Ad-Vance Medical Research
Ponce, 00717
Hospital Espanol Auxilio Mutuo
San Juan, 00918
VA Caribbean Healthcare System
San Juan, 00921-3201
Hospital Municipal de San Juan
San Juan, 00935

Other trials in Puerto Rico

Denmark3 sites

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Aalborg, 9000
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Aarhus C, 8000
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Odense C, 5000

Other trials in Denmark

Finland3 sites

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Helsinki, 00290 HUS
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Oulu, 90220
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Turku, SF-20520

Other trials in Finland

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)

Conditions: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Being tested: Ramucirumab, Capecitabine, Cisplatin, Placebo, Fluorouracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RamucirumabDrug
Also called LY3009806, IMC-1121B, Cyramza
Administered IV
CapecitabineDrug
Administered orally
CisplatinDrug
Administered IV
PlaceboDrug
Administered IV
FluorouracilDrug
Administered IV

Study groups in NCT02314117
Study group	Role	What they receive
Ramucirumab + Cisplatin + Capecitabine	Experimental	8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle. Receives: Drug: Ramucirumab; Drug: Capecitabine; Drug: Cisplatin; Drug: Fluorouracil
Placebo + Cisplatin + Capecitabine	Active comparator	Placebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle. Receives: Drug: Capecitabine; Drug: Cisplatin; Drug: Placebo; Drug: Fluorouracil

What is being measured

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

Progression-free Survival (PFS)
PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.
Measured: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)

Secondary outcomes (12)

Overall Survival (OS)
OS was time from the date of randomization to the date of death from any cause. If the participant was alive at the cutoff for analysis (or was lost to follow-up), OS data were censored for analysis on the last date the participant was known to be alive.
Measured: Randomization to Death from Any Cause (Up To 30 Months)
Progression- Free Survival 2 (PFS2)
PFS2 was defined as the time from the date of randomization to second disease progression (defined as objective radiological or symptomatic progression), or death of any cause, whichever occurs first. Participants alive and for whom a second disease progression has not been observed (including participants who did not receive any additional systemic anticancer treatments) were censored at the last time known to be alive and without second disease progression. The second progression refers to disease progression on or after additional systemic anticancer therapy, regardless if any earlier progression is observed or not(e.g. at the end of study treatment). It is assessed by investigator based on overall clinical evaluation, not limited to RECIST.
Measured: Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.1).Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).ORR calculated as:(sum of the number of participants with PRs and CRs) divided by (number of evaluable participants) multiplied by 100.
Measured: Randomization to Disease Progression (Up To 26 Months)
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
DCR was the percentage of participants with a best overall response of CR, PR, or SD as per Response using RECIST v1.1 criteria. Target lesions - CR: Disappearance of all lesions; any pathological lymph nodes must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum. Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Stable Disease: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Non target lesions - CR: Disappearance of all lesions and normalization of tumor marker levels; all lymph nodes must be non-pathological in size. Non-CR/Non-PD: Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels. PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Measured: Randomization to Disease Progression (Up To 26 Months)
Time to Progression (TTP)
TTP was time from the date of randomization to the date of radiographic progression (according to RECIST v.1.1). If a participant died due to any reason without radiographic progression, TTP is censored at the last adequate tumor assessment. Target lesions: Progressive Disease (PD): At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study (the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s). Non target lesions: PD: Unequivocal progression of existing lesions or the appearance of new lesion(s).
Measured: Randomization to Disease Progression (Up To 24 Months)
Duration of Response (DoR)
Participants achieved an objective response if they had a best overall response of CR or PR.Target lesions- CR:Disappearance of all lesions;any pathological lymph nodes must have reduction in short axis to <10 mm.PR: At least a 30% decrease in the sum of diameters of lesions vs the baseline sum.PD: At least a 20% increase in the sum of diameters of lesions vs the smallest sum on study(the sum must also demonstrate an absolute increase of at least 5 mm); or the appearance of new lesion(s).Non target lesions - CR: Disappearance of all lesions and normalization of tumour marker levels;all lymph nodes must be non-pathological in size. Non-CR/Non-PD:Persistence of lesion(s) and/or maintenance of abnormal tumor marker levels.PD:Unequivocal progression of existing lesions or the appearance of new lesion(s).If a participant was not known to have died or have radiographically documented PD as of the data inclusion cutoff date,DOR was censored at the date of the last adequate tumor assessment.
Measured: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
Time to sustained deterioration was defined as time from randomization to first worsening in QoL with no subsequent non-worsened assessment. Worsening in global health status/QoL was defined as a decrease of ≥10 points on a 100-point scale. If a participant did not report worsening, time to sustained deterioration was censored at date of last non-worsened assessment.
Measured: Randomization, First worsening in QoL (Up To 26 Months)
Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)
The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.
Measured: Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
The time from the date of randomization to the first date observing ECOG PS ≥2 (that is, deterioration from baseline status of 0 or 1). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. ECOG Performance Status: 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled. Cannot carry on any selfcare.Totally confined to bed or chair,5- Dead.
Measured: Randomization to ECOG PS ≥2 (Up To 26 Months)
Number of Participants With Anti-Ramucirumab Antibodies
Participants who developed treatment-emergent antibody responses to Ramucirumab postbaseline.
Measured: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Pharmacokinetics (PK): Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Measured: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
PK: Minimum Concentration (Cmin) of Ramucirumab
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab
Measured: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI

Timeline

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

20 Jan 201514 Aug 2020

First posted10 Dec 2014 (estimated)
Study start20 Jan 2015
Primary completion17 Jan 2017
Study completion14 Aug 2020

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 Metastatic Gastric AdenocarcinomaStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 645 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02314117
Sponsor's protocol ID: 15372
Other IDs: I4T-MC-JVCU, 2014-002240-40, 2014
Acronym: RAINFALL
Status last verified: Jul 2021
First submitted: 8 Dec 2014
Last updated: 26 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.
PubMed 34795131
Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1.
PubMed 30718072

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

RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Active, not recruitingPhase 1
A Study of KK2269 in Adult Participants With Solid Tumors
Advanced Solid Tumor, Metastatic Solid Tumor
RecruitingObservational study
A Study to Observe the Safety of VYLOY (Zolbetuximab) in People in South Korea With Gastric or Gastroesophageal Junction Cancer.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
Active, not recruitingPhase 3
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
RecruitingPhase 3
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer

All Metastatic Gastric Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Capecitabine and Cisplatin With or Without Ramucirumab as First-line Therapy in Patients With Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (RAINFALL)
ClinicalTrials.gov ID: NCT02314117
Acronym / sponsor ID: RAINFALL / 15372
Conditions: Metastatic Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 645 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 20 Jan 2015 (actual)
Primary completion: 17 Jan 2017 (actual)
Study completion: 14 Aug 2020 (actual)
First posted: 10 Dec 2014 (estimated)
Results: Posted 2 May 2018

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ramucirumab + Cisplatin + Capecitabine	Experimental	Drug: Ramucirumab, Drug: Capecitabine, Drug: Cisplatin, Drug: Fluorouracil8 milligrams/kilogram (mg/kg) ramucirumab given intravenously (IV) on days 1 and 8 in combination with 80 mg/square meter (m^2) cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day fluorouracil (5-FU) IV on days 1 to 5 of each 21-day cycle.
Placebo + Cisplatin + Capecitabine	Active comparator	Drug: Capecitabine, Drug: Cisplatin, Drug: Placebo, Drug: FluorouracilPlacebo for blinding given IV on days 1 and 8 in combination with 80 mg/m^2 cisplatin given IV on day 1 of each 21-day cycle (for up to 6 cycles) and 1000 mg/m^2 capecitabine given orally twice a day on days 1 through 14. Participants that were unable to take capecitabine will be given 800 mg/m^2/day 5-FU IV on days 1 to 5 of each 21-day cycle.

Who may qualify

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

Key inclusion criteria (7 listed)

Have a histopathologically confirmed diagnosis of metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. All histologies of nonsquamous cell origin including undifferentiated gastric carcinoma are eligible.
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after >12 months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Have measurable or nonmeasurable but evaluable disease determined using guidelines in Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1). Baseline tumor assessment should be performed using a high resolution computed tomography (CT) scan using IV and oral contrast unless clinically contra-indicated. Magnetic resonance imaging (MRI) is acceptable if a CT cannot be performed.
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale at baseline.
Have adequate organ function.

Key exclusion criteria (18 listed)

Participants with adenocarcinoma of the esophagus are excluded.
Participants with human epidermal growth factor receptor 2 (HER2)-positive status.
Participants receiving chronic therapy with nonsteroidal anti-inflammatory agents.
Have radiation therapy within 14 days prior to randomization.
Have documented brain metastases, leptomeningeal disease or uncontrolled spinal cord compression.

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
RamucirumabAlso: LY3009806, IMC-1121B, CyramzaAdministered IV	Drug	Ramucirumab + Cisplatin + Capecitabine
CapecitabineAdministered orally	Drug	Placebo + Cisplatin + Capecitabine, Ramucirumab + Cisplatin + Capecitabine
CisplatinAdministered IV	Drug	Placebo + Cisplatin + Capecitabine, Ramucirumab + Cisplatin + Capecitabine
PlaceboAdministered IV	Drug	Placebo + Cisplatin + Capecitabine
FluorouracilAdministered IV	Drug	Placebo + Cisplatin + Capecitabine, Ramucirumab + Cisplatin + Capecitabine

Primary outcome

Progression-free Survival (PFS)
Time frame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months)
PFS time was measured from the date of randomization to the date of radiographic(rgr) documentation of progression(by RECIST v.1.1) or the date of death due to any cause, whichever was earlier.If a participant did not have a complete baseline tumor assessment,then the PFS time was censored at the randomization date.If a participant was not known to have died or have rgr documented progression as of the data cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date. If death or progressive disease(PD) occurred after 2 or more consecutive missing rgr visits,censoring occurred at the date of the last rgr visit prior to the missed visits.If death or PD occurred after postdiscontinuation(pdis) systemic anticancer therapy,censoring occurred at the date of last rgr visit prior to the start of pdis systemic anticancer therapy. PD was defined according to RECIST v.1.1.

12 secondary outcomes

Overall Survival (OS)
Time frame: Randomization to Death from Any Cause (Up To 30 Months)
Progression- Free Survival 2 (PFS2)
Time frame: Randomization to Second Radiological or Symptomatic Disease Progression After the Start of Additional Systemic Anticancer Treatment or Death from Any Cause (Up To 26 Months)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
Time frame: Randomization to Disease Progression (Up To 26 Months)
Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) (Disease Control Rate [DCR])
Time frame: Randomization to Disease Progression (Up To 26 Months)
Time to Progression (TTP)
Time frame: Randomization to Disease Progression (Up To 24 Months)
Duration of Response (DoR)
Time frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Up To 26 Months)
Time to Deterioration in Quality of Life (QoL) on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status/ QoL Scale
Time frame: Randomization, First worsening in QoL (Up To 26 Months)
Change in Health Status on the EuroQol 5-Dimensions 5-Level Instrument (EQ-5D- 5L)
Time frame: Randomization, 30 Days After Treatment Discontinuation (Up To 5 Months)
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: Randomization to ECOG PS ≥2 (Up To 26 Months)
Number of Participants With Anti-Ramucirumab Antibodies
Time frame: Predose Cycle 1 through 30 Days After Treatment Discontinuation (Up To 24 Months)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Ramucirumab
Time frame: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI
PK: Minimum Concentration (Cmin) of Ramucirumab
Time frame: Cycle 1 Day 1: 1 hour (hr) end of infusion (EOI), Cycle 3 Day 1: 1hr EOI, Cycle 9 Day 1: 1 hr EOI

Results and safety

Results posted to the registry on 2 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ramucirumab + Cisplatin + Capecitabine	326	314
Placebo + Cisplatin + Capecitabine	319	303

Primary outcome: Progression-free Survival (PFS)

Time frame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 Months). Median (95% Confidence Interval). Unit: months

Measure	Ramucirumab + Cisplatin + Capecitabine n = 255	Placebo + Cisplatin + Capecitabine n = 253
Value	5.72 (5.45 to 6.51)	5.39 (4.47 to 5.72)

Ramucirumab + Cisplatin + Capecitabine vs Placebo + Cisplatin + Capecitabine: Hazard Ratio (HR): 0.753 (95% CI 0.607 to 0.935)

Population analysed: First 508 randomized participants. Participants censored: Ramucirumab + Cisplatin + Capecitabine=87 and Placebo + Cisplatin + Capecitabine=62.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Up To 5.6 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LY3009806+Capecitabine+Cisplatin	161 of 323 (49.8%)	315 of 323 (97.5%)	Not reported
Placebo+Capecitabine+Cisplatin	150 of 315 (47.6%)	304 of 315 (96.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34795131Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.
Derived from this study: PubMed 30718072Fuchs CS, Shitara K, Di Bartolomeo M, Lonardi S, Al-Batran SE, Van Cutsem E, Ilson DH, Alsina M, Chau I, Lacy J, Ducreux M, Mendez GA, Alavez AM, Takahari D, Mansoor W, Enzinger PC, Gorbounova V, Wainberg ZA, Hegewisch-Becker S, Ferry D, Lin J, Carlesi R, Das M, Shah MA; RAINFALL Study Group. Ramucirumab with cisplatin and fluoropyrimidine as first-line therapy in patients with metastatic gastric or junctional adenocarcinoma (RAINFALL): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):420-435. doi: 10.1016/S1470-2045(18)30791-5. Epub 2019 Feb 1.
A Study of Ramucirumab (LY3009806) in Combination With Capecitabine and Cisplatin in Participants With Stomach CancerLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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

135 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 18 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 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 135 sites in United States, Japan, Canada, Italy, Mexico and 15 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 2 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Randomization to Radiological Disease Progression or Death from Any Cause (Up to 26 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 NCT02314117, 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 26 Aug 2021; AzTrials last refreshed its copy on 26 Oct 2026.