Clinical trial · Interventional
Biomarker-Integrated Umbrella, Advanced Gastric Cancer
The Master Protocol for Biomarker-Integrated Umbrella Trial in Advanced Gastric Cancer
NCT02951091CI-TRIAL-00084195completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In-depth understanding of molecular characteristics of gastric cancer enabled us to realize personalized medicine with targeted agents in gastric cancer treatment. The investigators initiated open-label, randomized, controlled phase II, multi-arm trial comparing targeted therapy based on tumor molecular profiling with standard paclitaxel therapy as second line treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biomarker screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- biomarker group
- description
- 400 Her-2 (-) metastatic/recurrent gastric cancer patients will be centrally screened for druggable targets \[Epstein-Barr virus, Microsatellite instability, HER2, EGFR, c-MET, and PTEN\] by immunohistochemistry and in situ hybridization during first line chemotherapy. At the time of second line treatment, patients will be randomized to the biomarker vs control group as 4: 1 ratio. The biomarker group will be offered for entry into a specific protocol based on their molecular cohort and treated with specific targeted agents in combination with weekly paclitaxel; 1) EGFR cohort (EGFR 2+ or EGFR 3+) for pan-ERBB inhibitor (afatinib), 2)PTEN loss cohort (PTEN score less than 100) for PIK3CB inhibitor (GSK2636771), 3) PD-L1 positive, MSI-high, or EBV positive cases for nivolumab, 4) none for weekly paclitaxel.
- interventionNames
- Other: biomarker screening
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- Patients will be randomized to the biomarker vs control group (standard of care; paclitaxel) as 4:1 ratio.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer 2. Eastern Cooperative Oncology Group performance status of 0 to 1 3. Male or female; ≥ 19 years of age 4. On or progression after 1st line palliative chemotherapy 5. Subjects with evaluable lesion (using RECIST 1.1 criteria) 6. Subjects who meet the following criteria: * Absolute neutrophil count ≥ 1000 /µL * Platelet count ≥ 75,000/ µL * Serum creatinine \< 1.5 x upper limit of normal or Creatinine clearance ≥60 mL/min * aspartate aminotransferase and alanine transaminase 3 x upper limit of normal Exclusion Criteria: * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
References
Publications (1)
- DERIVEDLee CK, Kim HS, Jung M, Kim H, Bae WK, Koo DH, Jeung HC, Park SR, Hwang IG, Zang DY, Lee HW, Park S, Nam CM, Chung HC, Rha SY. Open-Label, Multicenter, Randomized, Biomarker-Integrated Umbrella Trial for Second-Line Treatment of Advanced Gastric Cancer: K-Umbrella Gastric Cancer Study. J Clin Oncol. 2024 Jan 20;42(3):348-357. doi: 10.1200/JCO.23.00971. Epub 2023 Oct 26. PMID 37883723