Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Conditions
Keywords
stomach cancer
Brief summary
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).
Interventions
DRUGRamucirumab
Administered IV
DRUGPaclitaxel
Administered IV
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The participant has a diagnosis of gastric or GEJ adenocarcinoma. * The participant has disease progression during or within 4 months after last dose of first-line chemotherapy or during or within 6 months after the last dose of neoadjuvant or adjuvant therapy. * The participant received combination chemotherapy, which must include a platinum and/or a fluoropyrimidine and must not include a taxane or antiangiogenic agent. * The disease is evaluable by imaging per Response Evaluation Criteria in Solid Tumors 1.1. * The participant has an Eastern Cooperative Oncology Group performance status of 0 or 1. * The participant has adequate organ function: * Total bilirubin ≤1.5 × the upper limit of normal (ULN) and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the liver has tumor involvement, AST and ALT \<5 × ULN. * Serum creatinine ≤1.5 × ULN or calculated creatinine clearance ≥50 milliliters/minute. * Urinary protein is \<2+. * Absolute neutrophil count ≥1.5 × 10\^9/liter (L), platelets ≥100 × 10\^9/L, and hemoglobin ≥9 grams/deciliter (5.58 millimoles/L). * International normalized ratio ≤1.5 × ULN and partial thromboplastin time ≤5 seconds above ULN. * The participant has an estimated life expectancy of minimum 12 weeks. * The participant has resolution to Grade 1 or less by Common Terminology Criteria for Adverse Events Version 4.0, of all clinically significant toxic effects of previous therapy. * The participant, if male, is sterile or agrees to use a reliable method of birth control. * The participant, if female, is surgically sterile, is postmenopausal, or agrees to use a highly effective method of birth control. * The participant, if female and of child-bearing potential, must have a negative pregnancy test.
Exclusion criteria
* The participant is receiving therapy with any of the following: * Nonsteroidal anti-inflammatory agents. * Other anti-platelet agents; Aspirin use at doses up to 325 milligrams (mg)/day is permitted. * The participant received radiotherapy within 14 days prior to randomization. * The participant received previous chemotherapy with a cumulative dose of \>900 mg per meter squared (mg/m\^2) of epirubicin or \>400 mg/m\^2 of doxorubicin. * The participant has documented brain metastases or leptomeningeal disease. * The participant has a significant bleeding disorder or vasculitis. * The participant experienced any arterial thromboembolic event within 6 months. * The participant has symptomatic congestive heart failure or symptomatic cardiac arrhythmia. * The participant has uncontrolled hypertension, despite antihypertensive intervention. * The participant underwent major surgery within 28 days. * The participant has a history of gastrointestinal perforation or fistula within 6 months. * The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months. * The participant has bowel obstruction or history of chronic diarrhea that is considered clinically significant. * The participant has either of the following: * Child-pugh B or C cirrhosis. * The participant has a serious illness or medical condition including: * Human immunodeficiency virus infection. * The participant has a concurrent active malignancy other than the following: * Nonmelanomatous skin cancer. * In situ carcinoma of the cervix or other noninvasive carcinoma or in situ neoplasm. * The participant has a serious nonhealing: (a) wound, (b) peptic ulcer, or (c) bone fracture. * The participant experienced any Grade 3 or 4 venous thromboembolic event that is not adequately treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ | 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 of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ | 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 of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST. |
| Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | 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 |
| Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) | 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. |
| Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)] | 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 in the sum of the 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 of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants\*100. |
| Number of Participants With Anti-Ramucirumab Antibodies | Cycle 1 Predose through Follow-up (Up To 24 Months) | Participants who had anti-ramucirumab antibodies at postbaseline. |
Countries
Belgium, Canada, Czechia, Germany, Greece, Italy, Spain, Sweden, Turkey (Türkiye), Ukraine, United States
Participant flow
Pre-assignment details
Completers are defined as participants who died or had progressive disease (PD) or completed treatment or did not complete treatment and were followed for survival data. Final study data will be provided after study completion.
Participants by arm
| Arm | Count |
|---|---|
| 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel 12mg/kg ramucirumab administered intravenously (IV) on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15. | 123 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel 8 mg/kg ramucirumab administered IV on day 1 and day 15 (28 day cycles) in combination with 80 mg/m² paclitaxel administered IV on day 1, day 8 and day 15. | 122 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Participant Never Treated | 0 | 2 |
Baseline characteristics
| Characteristic | 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Total | 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 12.3 | 58.3 years STANDARD_DEVIATION 11.8 | 58.6 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 218 Participants | 110 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 117 Participants | 236 Participants | 119 Participants |
| Region of Enrollment Belgium | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment Canada | 4 Participants | 4 Participants | 0 Participants |
| Region of Enrollment Czechia | 9 Participants | 16 Participants | 7 Participants |
| Region of Enrollment Germany | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment Greece | 11 Participants | 21 Participants | 10 Participants |
| Region of Enrollment Italy | 7 Participants | 23 Participants | 16 Participants |
| Region of Enrollment Spain | 33 Participants | 56 Participants | 23 Participants |
| Region of Enrollment Sweden | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Turkey | 16 Participants | 40 Participants | 24 Participants |
| Region of Enrollment Ukraine | 26 Participants | 44 Participants | 18 Participants |
| Region of Enrollment United States | 8 Participants | 24 Participants | 16 Participants |
| Sex: Female, Male Female | 44 Participants | 84 Participants | 40 Participants |
| Sex: Female, Male Male | 78 Participants | 161 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 81 / 123 | 76 / 120 |
| other Total, other adverse events | 117 / 123 | 115 / 120 |
| serious Total, serious adverse events | 47 / 123 | 32 / 120 |
Outcome results
Primary
Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ
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 of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Time frame: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Population: All randomized participants in arm 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel. Number of participants censored: Ramucirumab 12 mg/kg + 80 mg/m² Paclitaxel= 25. All randomized participants (including the censored participants) were included in the analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Progression Free Survival (PFS) in Ramucirumab 12mg/kg Arm I4T-MC-JVCZ | 5.42 months |
Comparison: This analysis were comparison of PFS for participants treated with ramucirumab 12 mg/kg plus paclitaxel in Study I4T-MC-JVCZ versus placebo plus paclitaxel in I4T-IE-JVBE (NCT01170663) using meta-analysis.~Placebo + 80 mg/m² Paclitaxel in I4T-IE-JVBE Number of participants: 335, Median (95% CI), months: 2.86 (2.79 to 3.02)95% CI: [0.447, 0.853]
Secondary
Number of Participants With Anti-Ramucirumab Antibodies
Participants who had anti-ramucirumab antibodies at postbaseline.
Time frame: Cycle 1 Predose through Follow-up (Up To 24 Months)
Population: All randomized participants who received at least one dose of study drug and were evaluable for ramucirumab anti-drug antibody.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Number of Participants With Anti-Ramucirumab Antibodies | 2 Participants |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Number of Participants With Anti-Ramucirumab Antibodies | 1 Participants |
Secondary
Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
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.
Time frame: Baseline to Objective Progressive Disease (Up To 21 Months)
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) | 27.6 percentage of participants |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR]) | 25.4 percentage of participants |
Secondary
Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)]
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 in the sum of the 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 of 1 or more new lesions is also considered progression. Non-Target PD is unequivocal progression of existing nontarget lesions. DCR=CR+PR+SD/total number of participants\*100.
Time frame: Baseline to Objective Progressive Disease (Up To 21 Months)
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)] | 78.9 percentage of participants |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Percentage of Participants Who Exhibit Stable Disease (SD) or Confirmed Response (CR) or Partial Response (PR) [Disease Control Rate (DCR)] | 75.4 percentage of participants |
Secondary
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination with Paclitaxel
Time frame: 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
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 2 Day 15 (Week 6) | 76.7 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 42 |
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 3 Day 15 (Week 10) | 99.0 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 44 |
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 2 Day 1 (Week 4) | 63.6 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 40 |
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 4 Day 1 (Week 12) | 101 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 55 |
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 3 Day 1(Week 8) | 91.2 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 40 |
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 1 Day 15 (Week 2) | 39.2 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 43 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 3 Day 1(Week 8) | 51.5 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 55 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 2 Day 1 (Week 4) | 37.1 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 50 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 2 Day 15 (Week 6) | 43.5 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 53 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 1 Day 15 (Week 2) | 21.4 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 58 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 3 Day 15 (Week 10) | 52.9 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 56 |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab in Combination With Paclitaxel | Cycle 4 Day 1 (Week 12) | 56.1 Microgram per milliliter (µg/mL) | Geometric Coefficient of Variation 56 |
Secondary
Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ
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 of 1 or more new lesions is also considered progression.Non-Target PD is unequivocal progression of existing nontarget lesions.A participant with incomplete baseline disease had PFS time censored at the enrollment date.A participant not known to have died or have RDP as of the data inclusion cutoff date for the analysis had PFS time censored at date of the last complete RDP-free disease AST.
Time frame: Randomization to Objective Progressive Disease or Death (Up To 21 Months)
Population: All randomized participants. Number of participants censored: Ramucirumab 12 mg/kg + Paclitaxel 80 mg/m2= 25 and 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel =23. All randomized participants (including the censored participants) were included in the analyses.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| I4T-MC-JVCZ: 12mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ | 5.42 months |
| 8 mg/kg Ramucirumab + 80 mg/m² Paclitaxel | Progression Free Survival (PFS) Ramucirumab 12mg/kg Arm and 8mg/kg Arm in I4T-MC-JVCZ | 5.16 months |
95% CI: [0.727, 1.274]