18 and older, any sex, with Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZPrimary· Randomization to Objective Progressive Disease or Death (Up To 21 Months)
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment (AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance
Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZSecondary· Randomization to Objective Progressive Disease or Death (Up To 21 Months)
PFS was defined as time from the date of randomization(RD) to date of radiographic documentation of progression(RDP) or the date of death due to any cause, whichever is earlier as defined by RECIST v.1.1. Participants with no tumor progression and no death were censored at date of last adequate radiological assessment(AST) or date of RD(whichever is later).PD is at least a 20% increase in sum of diameters of target lesions,taking as reference the smallest sum on study.In addition to the relative increase of 20%,the sum must also demonstrate an absolute increase of at least 5 mm.The appearance
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
5.42
4.40 – 6.01
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
5.16
3.81 – 5.65
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With PaclitaxelSecondary· Cycle(C) 1 Day(D) 1: Prior to Infusion(PTI),1 to 1.5 hours(hrs) after end of Infusion(EOI); C1 D15: 3 days PTI; C2 D1: 3 days PTI; C2 D15: 3 days PTI,1 to 1.5 hrs after EOI; C3 D1 and 15: 3 days PTI; C4 D1: 3 days PTI and 1 to 1.5 hrs after EOI
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel
Cycle 1 Day 15 (Week 2)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
39.2
± 43
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
21.4
± 58
Cycle 2 Day 1 (Week 4)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
63.6
± 40
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
37.1
± 50
Cycle 2 Day 15 (Week 6)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
76.7
± 42
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
43.5
± 53
Cycle 3 Day 1(Week 8)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
91.2
± 40
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
51.5
± 55
Cycle 3 Day 15 (Week 10)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
99.0
± 44
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
52.9
± 56
Cycle 4 Day 1 (Week 12)
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
101
± 55
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
56.1
± 56
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])Secondary· Baseline to Objective Progressive Disease (Up To 21 Months)
ORR was defined as the percentage of participants who achieved a PR or CR per RECIST v.1.1.CR is the disappearance of all target lesions.Any pathological lymph nodes(whether target or non-target)must have reduction in short axis to\<10mm.Tumor marker results must have normalized.PR is at least a 30% decrease in the sum of diameter of target lesions,taking as reference the baseline sum diameters.ORR is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
27.6
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
25.4
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]Secondary· Baseline to Objective Progressive Disease (Up To 21 Months)
DCR is defined as the percentage of participants who achieved CR, PR, or SD per RECIST v.1.1. CR is the disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have reduction in short axis to \<10 mm.Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD is at least a 20% increase
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
78.9
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
75.4
Number of Participants With Anti-Ramucirumab AntibodiesSecondary· Cycle 1 Predose through Follow-up (Up To 24 Months)
Participants who had anti-ramucirumab antibodies at postbaseline.
Group
Value
95% CI
12mg/kg Ramucirumab + 80 mg/m² Paclitaxel
2
8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up To 40 Months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The main purpose of this study is to evaluate the efficacy of an alternative dose of ramucirumab in combination with paclitaxel in participants with second-line metastatic or locally advanced, unresectable gastric or gastroesophageal junction adenocarcinoma (GEJ).
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06996782 — A Platform Study in Non-Small Cell Lung Cancer (NSCLC)
· Phase 1, PHASE2
· recruiting
NCT06675136 — Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal
· Phase 1
· recruiting
NCT07098338 — A Study of Novel Combinations in Non-Small Cell Lung Cancer (NSCLC)
· Phase 2
· recruiting
NCT06616584 — Adding the Immunotherapy Drug Cemiplimab to Usual Treatment for People With Advanced Non-Small Cell Lung Cancer Who Had
· Phase 2, PHASE3
· recruiting
NCT06771622 — Safety and Efficacy of HCB101 in Combination With Multiple Agents in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· active not recruiting
Other recruiting trials for Gastric Adenocarcinoma
Currently open trials in the same condition.
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· recruiting
NCT07522320 — Costs of Opportunistic Upper Gastrointestinal Endoscopy and the Economic Burden of Gastric Cancer Management
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NCT07182149 — A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
· Phase 1
· recruiting
NCT07001748 — Testing the Addition of Paclitaxel Administered Into the Abdominal Cavity Combined With Chemotherapy for Patients With G
· Phase 2, PHASE3
· recruiting
NCT07103668 — A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
· Phase 3
· recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
Last refreshed: 17 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02514551.