Description:
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to
compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line
(1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Title
- Brief Title: Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
- Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
BGB-A317-305
- SECONDARY ID:
2018-000312-24
- SECONDARY ID:
CTR20181841
- SECONDARY ID:
JapicCTI-194799
- NCT ID:
NCT03777657
Conditions
- Gastric, or Gastroesophageal Junction Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
Tislelizumab | BGB-A317 | Tislelizumab (BGB-A317) + chemotherapy |
Placebo | | Placebo + chemotherapy |
Cisplatin | | Placebo + chemotherapy |
Oxaliplatin | | Placebo + chemotherapy |
Capecitabine | | Placebo + chemotherapy |
5-FU | | Placebo + chemotherapy |
Purpose
This is a randomized (1:1), double-blind, placebo-controlled, Phase 3 study designed to
compare the efficacy and safety of tislelizumab or placebo plus chemotherapy as first-line
(1L) therapy for locally advanced unresectable or metastatic gastric or gastroesophageal
junction (GEJ) adenocarcinoma.
Trial Arms
Name | Type | Description | Interventions |
---|
Tislelizumab (BGB-A317) + chemotherapy | Experimental | Tislelizumab and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-Fluorouracil regimens are used as the backbone chemotherapy. | - Tislelizumab
- Cisplatin
- Oxaliplatin
- Capecitabine
- 5-FU
|
Placebo + chemotherapy | Placebo Comparator | Placebo and chemotherapy. Oxaliplatin + capecitabine or cisplatin + 5-FU regimens are used as the backbone chemotherapy. | - Placebo
- Cisplatin
- Oxaliplatin
- Capecitabine
- 5-FU
|
Eligibility Criteria
Key Inclusion Criteria:
1. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have
histologically confirmed adenocarcinoma
2. No previous systemic therapy for locally advanced unresectable or metastatic
gastric/GEJ cancer. NOTE: Participants may have received prior neoadjuvant or adjuvant
therapy as long as it was completed and have no recurrence or disease progression for
at least 6 months.
3. ECOG PS ≤ 1 within 7 days prior to randomization
4. Adequate organ function as indicated by the following laboratory values ≤ days prior
to randomization
Key Exclusion Criteria:
1. Has squamous cell or undifferentiated or other histological type GC
2. Active leptomeningeal disease or uncontrolled brain metastasis
3. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Survival (OS) |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | The time from the date of randomization to the date of death due to any cause |
Secondary Outcome Measures
Measure: | Progression-free survival (PFS) |
Time Frame: | Up to 30 months |
Safety Issue: | |
Description: | The time from the date of randomization to the date of the first objectively documented tumor progression |
Measure: | Overall response rate (ORR) |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | The proportion of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 |
Measure: | Duration of response (DOR) |
Time Frame: | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months |
Safety Issue: | |
Description: | The time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first |
Measure: | Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 (EORTC QLQ-STO22) |
Time Frame: | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Score (EORTC QLQ-30) |
Time Frame: | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Change from baseline in European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score (EQ-5D-5L) |
Time Frame: | Baseline, at every cycle through cycle 6 (each cycle is 21 days), and then every other cycle for up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing Adverse Events (AEs) |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Number of participants experiencing Serious Adverse Events (SAEs) |
Time Frame: | Up to 48 months |
Safety Issue: | |
Description: | |
Measure: | Disease control rate (DCR) |
Time Frame: | Up to 48 Months |
Safety Issue: | |
Description: | Proportion of complete response + partial response + stable disease |
Measure: | clinical benefit rate (CBR) |
Time Frame: | Up to 48 Months |
Safety Issue: | |
Description: | Proportion of complete response + partial response + durable stable disease |
Measure: | time to response (TTR) |
Time Frame: | Up to 48 Months |
Safety Issue: | |
Description: | Time from randomization to the first determination of an objective response |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | BeiGene |
Last Updated
August 6, 2021