Why gastric cancer trial monitoring matters in 2026
Gastric and gastroesophageal junction (GEJ) adenocarcinoma is the fifth most common cancer worldwide, with over one million new cases annually. While incidence is declining in Western populations, it remains extremely prevalent in East Asia (Japan, Korea, China), and the majority of patients present with advanced disease and poor prognosis.
The gastric cancer pipeline in 2026 is undergoing a transformation driven by several converging targets:
- CLDN18.2 (Claudin 18.2) — zolbetuximab (Vyloy) received FDA approval in 2024 for CLDN18.2-positive, HER2-negative gastric/GEJ cancer. This marks the validation of CLDN18.2 as a key target; ADCs, bispecifics, and CAR-T cells targeting CLDN18.2 are now pouring into trials
- HER2-targeted ADCs — trastuzumab deruxtecan (T-DXd / Enhertu) has shown transformative activity in HER2-positive gastric cancer, displacing standard HER2 therapy. Multiple next-gen HER2 ADCs are in development
- PD-1/PD-L1 combinations — nivolumab (CheckMate 649), pembrolizumab, and tislelizumab are now first-line standards in high CPS tumors; ongoing trials are defining maintenance, combination, and biomarker strategies
- FGFR2b inhibitors — bemarituzumab (anti-FGFR2b) showed Phase 3 activity in FGFR2b-overexpressing tumors; approval expected imminently
- VEGFR2 and anti-angiogenic — ramucirumab remains active; combinations with IO being explored
- EGFR and MET-targeted agents — in molecularly selected subpopulations
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Start Free — No Credit CardActive Phase 3 gastric cancer trials (2026)
27 Phase 3 programs are active in gastric/GEJ cancer, spanning FGFR2b, HER2, CLDN18.2, PD-1/TIGIT, and novel chemotherapy combinations:
| NCT ID | Trial / Agent | Sponsor | Status |
|---|---|---|---|
| NCT05052801 | Bemarituzumab (FGFR2b) + FOLFOX6 vs placebo + FOLFOX6, 1L FGFR2b+ gastric/GEJ (FIGHT) | Amgen | Active (Enrollment Complete) |
| NCT06731478 | T-DXd + chemo + pembrolizumab + trastuzumab vs SOC, 1L HER2+ gastric/GEJ (DESTINY-Gastric04) | Daiichi Sankyo | Recruiting |
| NCT05152147 | Zanidatamab + chemo ± tislelizumab vs SOC, 1L HER2+ gastric/GEJ | Jazz Pharmaceuticals | Active (Enrollment Complete) |
| NCT07315750 | Disitamab vedotin + trastuzumab + tislelizumab vs chemo + trastuzumab + pembro, 1L HER2+ gastric | RemeGen | Recruiting |
| NCT07118527 | SHR-A1811 (HER2 ADC) + chemo + adebrelimab vs SOC, 1L HER2+ gastric/GEJ | Hengrui / Suncadia | Recruiting |
| NCT07432836 | JSKN003 (HER2 ADC) vs physician choice, 2L+ HER2+ gastric cancer | Shanghai JMT-Bio | Not Yet Recruiting |
| NCT06346392 | AZD0901 (sonesitatug vedotin, CLDN18.2 ADC) vs investigator's choice, 2L+ CLDN18.2+ gastric | AstraZeneca | Recruiting |
| NCT07431281 | Sonesitatug vedotin (CLDN18.2 ADC) + capecitabine ± rilvegostomig, 1L CLDN18.2+ gastric | AstraZeneca | Recruiting |
| NCT07284134 | JS107 (CLDN18.2 ADC) vs investigator's choice, 2L+ CLDN18.2+ gastric cancer | Shanghai Junshi Bioscience | Recruiting |
| NCT06764875 | Rilvegostomig (PD-1/TIGIT bispecific) + fluoropyrimidine + trastuzumab, 1L HER2+ gastric | AstraZeneca | Recruiting |
| NCT07221149 | Pumitamig (CCR8) + chemotherapy vs chemotherapy in gastric/GEJ cancer | Bristol-Myers Squibb | Recruiting |
| NCT06532006 | HLX22 (HER2 bispecific) + trastuzumab + chemotherapy, 1L HER2+ gastric | Shanghai Henlius Biotech | Recruiting |
| NCT07449780 | AK104 (PD-1+CTLA-4) + XELOX vs standard in gastric/GEJ cancer | Akeso | Not Yet Recruiting |
| NCT07392892 | PF-08634404 + standard therapy in gastric/GEJ cancer | Pfizer | Not Yet Recruiting |
What we monitor for gastric cancer
Our system pulls from the ClinicalTrials.gov API every day. For a gastric cancer watch profile, you can configure alerts for:
- Condition keywords: "gastric cancer", "stomach cancer", "gastroesophageal junction", "GEJ adenocarcinoma", "gastric adenocarcinoma", "gastroesophageal cancer"
- Drug/target keywords: "CLDN18.2", "claudin 18", "zolbetuximab", "HER2 gastric", "trastuzumab deruxtecan", "FGFR2b", "bemarituzumab", "ramucirumab" — any drug or target you're tracking
- Phase filter: Phase 1 for early programs, Phase 2/3 for competitive commercial data
- Sponsor type: Industry only or all sponsors including major academic sites in East Asia and the US
- Status changes: New registrations, enrollment opens, status updates, and results postings
Bemarituzumab (FGFR2b) — Phase 3 complete, approval decision approaching
Bemarituzumab (Amgen) is an anti-FGFR2b antibody that blocks fibroblast growth factor receptor 2b signaling. Approximately 30% of gastric/GEJ adenocarcinomas overexpress FGFR2b — a molecularly selected population. The FIGHT Phase 3 trial (NCT05052801) completed enrollment and compares bemarituzumab + mFOLFOX6 versus placebo + mFOLFOX6 in first-line FGFR2b-overexpressing gastric/GEJ cancer.
Phase 2 (FIGHT-101 and FIGHT-302) demonstrated meaningful survival benefit in the FGFR2b-selected population, with 24-month OS around 38% vs 25% for chemotherapy alone. The biomarker selection (FGFR2b overexpression by IHC or FISH) creates a distinct patient segment — approximately 5,000 new patients annually in the US. BLA filing and FDA review are anticipated in 2026.
The FGFR2b program represents one of the few positive Phase 3 results in gastric cancer outside PD-1 and HER2 targeting, validating a third biomarker-defined subtype for treatment selection alongside HER2 and MSI-H status.
T-DXd redefining HER2-positive gastric cancer — from 2nd-line to 1st-line quadruplet
Trastuzumab deruxtecan (T-DXd, Enhertu; Daiichi Sankyo/AstraZeneca) received approval in HER2-positive gastric/GEJ cancer based on DESTINY-Gastric01 (Japan/Korea, 40.5% ORR vs 11.3% for standard), extending to global approval with DESTINY-Gastric02. In 2026, the T-DXd program is moving into the first-line setting:
- DESTINY-Gastric04 (NCT06731478): 1L quadruplet — T-DXd + chemotherapy + pembrolizumab + trastuzumab vs current standard (trastuzumab + chemo + pembrolizumab). If positive, would represent the most aggressive displacement of a standard-of-care in HER2+ gastric cancer
- Rationale: ToGA established trastuzumab + chemo; CheckMate 649 established nivolumab + chemo ± trastuzumab; KEYNOTE-811 established pembrolizumab + trastuzumab + chemo. Adding T-DXd to this triplet tests whether ADC-mediated HER2-directed cytotoxicity adds further survival benefit
HER2 amplification occurs in approximately 15–20% of gastric/GEJ adenocarcinomas — the highest-prevalence molecularly defined subtype — making HER2 programs the most commercially significant in the indication. Multiple competitors are racing to displace trastuzumab: T-DXd (Daiichi Sankyo), zanidatamab (Jazz/Zymeworks), disitamab vedotin (RemeGen), KN026 (JMT-Bio), HLX22 (Henlius), and SHR-A1811 (Hengrui).
SHR-A1811 (Hengrui/Suncadia): A new entry to the 1L HER2+ gastric Phase 3 race. SHR-A1811 is Hengrui's proprietary HER2 ADC — the same molecule showing activity in breast cancer — now in a Phase 3 trial (NCT07118527) combining it with chemotherapy and adebrelimab (Hengrui's PD-L1 antibody) vs. standard of care in previously untreated HER2-positive gastric or GEJ adenocarcinoma. This is a distinctly Chinese commercial strategy: Hengrui controls both the ADC and the PD-L1 checkpoint, enabling a single-sponsor triplet without partnership royalties. For global competitive intelligence teams, SHR-A1811's gastric Phase 3 join a crowded 1L space but represent a significant internal Chinese market opportunity.
CLDN18.2: zolbetuximab approved, ADC race enters Phase 3
The 2024 approval of zolbetuximab (Vyloy; Astellas) in CLDN18.2-positive, HER2-negative gastric/GEJ cancer validated Claudin 18.2 as the third major targetable biomarker after HER2 and MSI-H status. Approximately 38% of gastric cancers express CLDN18.2 at moderate-high levels. The CLDN18.2 competition is now moving toward ADCs and beyond the monoclonal antibody:
- Sonesitatug vedotin (AZD0901, AstraZeneca): CLDN18.2 ADC in two Phase 3 trials — as 2nd-line monotherapy vs investigator's choice (NCT06346392) and as 1st-line combination with capecitabine ± rilvegostomig (NCT07431281, the PD-1/TIGIT bispecific)
- JS107 (Junshi Bioscience): CLDN18.2 ADC vs investigator's choice in 2nd-line Phase 3 (NCT07284134)
- CMG901 (AstraZeneca/Keymed): Phase 1/2 CLDN18.2 ADC with strong early signals
- CAR-T cells: CLDN18.2-directed CAR-T programs in Phase 1/2 in China — potential "functional cure" approach in a small patient subset
AstraZeneca alone has three separate CLDN18.2/PD-1 combination trials in Phase 3, making gastric cancer one of the most active oncology programs in AZ's pipeline.
Rilvegostomig (PD-1/TIGIT bispecific) — AstraZeneca's multi-indication bet
Rilvegostomig is a bispecific antibody blocking both PD-1 and TIGIT on a single molecule (compared to combination of separate antibodies). TIGIT is an inhibitory checkpoint expressed on tumor-infiltrating T cells; co-blockade with PD-1 enhances T-cell activation in a synergistic mechanism distinct from anti-CTLA-4. AstraZeneca is testing rilvegostomig in multiple gastric cancer contexts in 2026:
- 1L HER2+ gastric + trastuzumab + fluoropyrimidine (NCT06764875) — testing PD-1/TIGIT in the HER2+ setting
- 1L CLDN18.2+ gastric alongside sonesitatug vedotin + capecitabine (NCT07431281) — CLDN18.2 ADC + PD-1/TIGIT combination
The rilvegostomig program reflects the broader industry question of whether combined PD-1+TIGIT co-blockade on a single molecule provides meaningful advantages over adding separate anti-TIGIT antibodies to PD-1/PD-L1 therapy — a question that failed for tiragolumab (Roche) in lung cancer but remains open for other indications and molecules.
Who uses gastric cancer trial monitoring
- GI oncology BD teams — tracking CLDN18.2, HER2, and FGFR2b competitor programs for partnering and pipeline decisions
- Oncology investors — monitoring Phase 2/3 initiations and enrollment milestones in gastric cancer
- GI oncologists and research sites — staying current on available trials for patients with advanced gastric/GEJ cancer
- CROs with GI oncology practices — tracking competing enrollment across the major Phase 3 gastric programs
- Academic researchers in gastric oncology — following the global competitive landscape including East Asian programs
Stay ahead of the gastric cancer pipeline
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Track Free Gastric Cancer TrialsHow DataLookout works
We run a direct API connection to ClinicalTrials.gov every morning, collecting all new and updated trials. Our matching engine compares each trial against your profile — condition keywords, drug targets, phase, sponsor type, and study status. Only relevant trials reach your inbox.
Your daily digest includes: trial title, phase, sponsor, current status, enrollment target, primary endpoint, and a direct link to the ClinicalTrials.gov record. No noise, no duplicate alerts.
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Frequently asked questions
How many gastric cancer clinical trials are currently recruiting?
As of March 2026, 177 gastric and gastroesophageal junction (GEJ) cancer clinical trials are actively recruiting patients on ClinicalTrials.gov, with 27 Phase 3 programs active across all lines of therapy and biomarker subgroups.
Is bemarituzumab (FGFR2b) approved for gastric cancer?
Not yet as of March 2026. Amgen's bemarituzumab completed Phase 3 enrollment in the FIGHT trial (NCT05052801) testing FOLFOX6 + bemarituzumab vs FOLFOX6 + placebo in FGFR2b-overexpressing gastric/GEJ cancer. Phase 2 data showed meaningful survival benefit (~38% vs 25% 24-month OS) in FGFR2b-selected patients. BLA filing and FDA review are anticipated in 2026. If approved, it would be the third biomarker-directed therapy approved in gastric cancer after HER2-targeted agents and zolbetuximab (CLDN18.2).
What is CLDN18.2 and which therapies target it in gastric cancer?
Claudin 18.2 (CLDN18.2) is a tight junction protein expressed in ~38% of gastric adenocarcinomas. Zolbetuximab (Vyloy, Astellas) is an approved anti-CLDN18.2 monoclonal antibody for HER2-negative, CLDN18.2-positive gastric/GEJ cancer. In 2026, the next generation is entering Phase 3: sonesitatug vedotin (AstraZeneca CLDN18.2 ADC, 2 Phase 3 trials), JS107 (Junshi Bioscience CLDN18.2 ADC, Phase 3), and multiple combination strategies pairing CLDN18.2-directed therapy with PD-1/TIGIT co-blockade.
How is HER2-positive gastric cancer treated in 2026?
Current standard of care for 1L HER2-positive gastric/GEJ adenocarcinoma is trastuzumab + pembrolizumab + chemotherapy (KEYNOTE-811). Trastuzumab deruxtecan (T-DXd, Enhertu) is approved in second-line based on DESTINY-Gastric01/02. In 2026, DESTINY-Gastric04 (NCT06731478) tests T-DXd + chemo + pembrolizumab + trastuzumab as a 1L quadruplet. Multiple competing HER2 programs in Phase 3 include zanidatamab (Jazz), disitamab vedotin (RemeGen), HLX22 (Henlius), and KN026 (JMT-Bio).
Does DataLookout cover gastric cancer trials from China and Japan?
Yes. ClinicalTrials.gov includes internationally conducted trials. A significant proportion of the gastric cancer Phase 3 pipeline originates from Chinese sponsors (RemeGen, Henlius, Hengrui, Junshi, JMT-Bio) and Japanese/Korean academic centers. DataLookout monitors all ClinicalTrials.gov-registered studies, including trials with primary enrollment in East Asia where gastric cancer incidence is highest.