LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
CompletedPhase 3Results postedLast updated 7 August 2025
What this trial tests
Phase 3 trial testing Lapatinib in Neoplasms, Gastrointestinal Tract in 545 participants. Completed in 3 October 2024.
18 and older, any sex, with Neoplasms, Gastrointestinal Tract. 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.
Overall Survival at the Time of Primary AnalysisPrimary· From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)
Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.
Group
Value
95% CI
CapeOx Plus Lapatinib
12.2
10.6 – 14.2
CapeOx Plus Placebo
10.5
9.0 – 11.3
Overall Survival in All Randomized Participants at the Time of Primary AnalysisPrimary· From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years)
Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.
Group
Value
95% CI
CapeOx Plus Lapatinib
11.9
10.4 – 13.8
CapeOx Plus Placebo
10.4
9.1 – 11.3
Overall Survival at the Time of Final AnalysisSecondary· From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing.
Group
Value
95% CI
CapeOx Plus Lapatinib
12.0
10.4 – 13.8
CapeOx Plus Placebo
10.4
9.0 – 11.3
Progression Free Survival (PFS)Secondary· From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
Progression-Free Survival (PFS) was defined as the time from randomization to the earliest occurrence of disease progression or death from any cause. Per RECIST v1.0, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants with symptomatic progression, even without radiological confirmation, were also counted. Those who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Participants who received no
Group
Value
95% CI
CapeOx Plus Lapatinib
6.2
5.6 – 7.0
CapeOx Plus Placebo
5.4
4.4 – 5.7
Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR)Secondary· From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation.
Group
Value
95% CI
CapeOx Plus Lapatinib
131
CapeOx Plus Placebo
94
Percentage of Participants With Clinical Benefit (CB)Secondary· From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
Clinical Benefit (CB) was defined as evidence of a complete response (CR), partial response (PR), or stable disease (SD). CR referred to the disappearance of all target and non-target lesions, PR to at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, and SD to neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, based on the smallest sum of diameters recorded since treatment initiation. All assessments were made by the investigator.
Group
Value
95% CI
CapeOx Plus Lapatinib
199
CapeOx Plus Placebo
188
Time to Response (TTR)Secondary· From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
Time to Response (TTR) was defined as the duration from randomization to the first documented evidence of either a complete response (CR) (the disappearance of all target and non-target lesions) or a partial response (PR) (at least a 30% reduction in the sum of the longest diameters of target lesions from baseline) as assessed by the investigator.
Group
Value
95% CI
CapeOx Plus Lapatinib
1.4
1.4 – 1.5
CapeOx Plus Placebo
1.4
1.4 – 1.6
Duration of Response (DOR)Secondary· From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
Duration of Response (DOR) was defined as the time from the first documented evidence of a complete response (CR) or partial response (PR) until the first recorded sign of disease progression or death from any cause. According to RECIST, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Those who received non-study anti-cancer therapies b
Group
Value
95% CI
CapeOx Plus Lapatinib
7.3
6.4 – 8.5
CapeOx Plus Placebo
5.6
4.6 – 6.0
Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE)Secondary· From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its causal relationship. This included any unfavorable or unintended sign (such as abnormal lab findings), symptom, or disease, whether new or worsened. A Serious Adverse Event (SAE) was defined as any such occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of dru
On-Therapy Adverse Events (Any AE regardless of seriousness)
Group
Value
95% CI
CapeOx Plus Lapatinib
255
CapeOx Plus Placebo
237
On-Therapy Serious Adverse Events
Group
Value
95% CI
CapeOx Plus Lapatinib
73
CapeOx Plus Placebo
54
Percentage of Participants With On-therapy Adverse Event (AE) by Maximum GradeSecondary· From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its relationship to the product. This included any unfavorable or unintended sign (such as abnormal lab results), symptom, or disease, whether new or worsened. The severity of AEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity).
Group
Value
95% CI
CapeOx Plus Lapatinib
43
CapeOx Plus Placebo
56
CapeOx Plus Lapatinib
85
CapeOx Plus Placebo
78
CapeOx Plus Lapatinib
94
CapeOx Plus Placebo
69
CapeOx Plus Lapatinib
17
CapeOx Plus Placebo
25
Percentage of Participants With On-therapy Serious Adverse Event (SAE) by Maximum GradeSecondary· From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
A Serious Adverse Event (SAE) was defined as any such occurrence that resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. The severity of SAEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity).
Group
Value
95% CI
CapeOx Plus Lapatinib
3
CapeOx Plus Placebo
3
CapeOx Plus Lapatinib
6
CapeOx Plus Placebo
4
CapeOx Plus Lapatinib
37
CapeOx Plus Placebo
21
CapeOx Plus Lapatinib
13
CapeOx Plus Placebo
18
Mean Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QOL) Questionnaire Core 30 (QLQ-C30) Domain ScoresSecondary· From Baseline up to disease progression (PD), assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years)
The EORTC QLQ-C30 is a comprehensive questionnaire developed for assessing the quality of life of cancer patients across different aspects including function scales namely physical, role, cognitive, emotional and social; symptom scales such as fatigue, pain, nausea and vomiting; and a global scale pronouncing overall health status. Its scoring method involves a 4-point Likert scale (ranging from 1 'Not at all' to 4 'Very Much'). Domain scores are calculated by averaging the items within the respective domain and then linearly transforming the score to fit within a 0-100 scale to finalize the s
Global health status/QoL
Group
Value
95% CI
CapeOx Plus Lapatinib
-6.6
± 24.63
CapeOx Plus Placebo
-5.1
± 23.97
Physical functioning
Group
Value
95% CI
CapeOx Plus Lapatinib
-9.4
± 25.61
CapeOx Plus Placebo
-9.6
± 22.33
Role functioning
Group
Value
95% CI
CapeOx Plus Lapatinib
-8.9
± 34.64
CapeOx Plus Placebo
-11.7
± 31.67
Emotional functioning
Group
Value
95% CI
CapeOx Plus Lapatinib
-3.8
± 27.37
CapeOx Plus Placebo
-7.1
± 23.61
Cognitive functioning
Group
Value
95% CI
CapeOx Plus Lapatinib
-7.4
± 21.41
CapeOx Plus Placebo
-10.4
± 21.98
Social functioning
Group
Value
95% CI
CapeOx Plus Lapatinib
-4.9
± 32.54
CapeOx Plus Placebo
-0.5
± 26.52
Fatigue
Group
Value
95% CI
CapeOx Plus Lapatinib
5.5
± 26.42
CapeOx Plus Placebo
5.6
± 25.30
Nausea and vomiting
Group
Value
95% CI
CapeOx Plus Lapatinib
3.3
± 27.69
CapeOx Plus Placebo
4.4
± 20.62
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were documented from the first administration of the study medication through the end of the Long-Term Follow-up (LTFU) period, covering a duration of up to approximately 16 years. Deaths were recorded from the study initiation through the end of the LTFU period, also assessed up to approximately 16 years. On-treatment period (up to 30 days after last dose) and post-treatment follow-up phase (thereafter) are reported separately..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
CapeOx Plus Lapatinib
Serious: 73/270 (27%)
Deaths: 42/272
CapeOx Plus Placebo
Serious: 54/267 (20%)
Deaths: 40/273
CapeOx Plus Lapatinib (Long Term Follow-up (LTFU))
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2) gene. The trial investigated whether lapatinib, when added to the chemotherapy regimen, capecitabine plus oxaliplatin (CapeOx), extended the time to progression and overall survival. Tumor ErbB2 (HER2) status had to be known before trial entry. CapeOx was administered to all patients, and patients were randomly assigned to receive either lapatinib or placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03784014 — Molecular Profiling of Advanced Soft-tissue Sarcomas
· Phase 3
· active not recruiting
NCT03523585 — DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
· Phase 3
· completed
NCT04185649 — The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer
· Phase 3
· unknown
NCT03500380 — A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without L
· Phase 2, PHASE3
· unknown
NCT03084939 — Efficacy and Safety of Trastuzumab Emtansine in Chinese Participants With Human Epidermal Growth Factor Receptor 2 (HER2
· Phase 3
· completed
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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 Novartis Pharmaceuticals
Last refreshed: 7 August 2025
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/NCT00680901.