New antibody combined with chemotherapy shows promising results in non-small cell lung cancer patients
CANCER DIGEST – NOV. 6, 2026 – A new therapy for patients with untreated advanced non-small cell lung cancer combining a first in class antibody with chemotherapy has shown strong effectiveness in an early Phase 2 clinical trial.
Led by Dr. Fei Zhou, of the Shanghai East Hospital, Tongji University School of Medicine, the research team enrolled 169 advanced non-small lung cancer patients across 13 medical institutions in China between Jan. 15, 2024, and May 21, 2025. The results were published Nov. 5, 2026 in JAMA Oncology.
Advanced NSCLC accounts for roughly 85% of all lung cancer cases globally and continues to carry high mortality rates. While immunotherapy drugs have shifted the standard of care in recent years researchers are continuing to find ways to increase initial response rates and extend long-term durability.
This trial aimed to test the response rates and safety of HB0025, a first-in-class dual-action antibody that simultaneously induces programmed cell death in the tumor and blocks vascular endothelial growth factor (VEGF), a crucial signaling pathway tumors use to grow new blood vessels.
In the trial 169 patients with advanced non-small cell lung cancer who had not received prior treatments were divided into two groups, 84 with squamous cell cancer and 85 with nonsquamous cell cancer. Squamous cell lung cancer occurs in the scale-like cells that line the airways and is often associated with a long history of heavy smoking. Nonsquamous cell lung cancer involves glandular tissues also occurs in smokers, but is more common among non-smokers.
Each group was treated with one of two doses of HB0025 along with standard chemotherapy. Patients received intravenous 10-mg/kg HB0025 every 3 weeks or 20-mg/kg HB0025 every 3 weeks plus chemotherapy: pemetrexed/carboplatin (Alimta®) for nonsquamous and paclitaxel/carboplatin (CarboTaxol) for squamous for up to 6 cycles.
The researchers analyzed the results for objective response rates (ORR), meaning the percentage of patients whose cancer shrank or disappeared following the treatment. In the squamous cell group, the ORR was 74.2% meaning three-quarters of these patients had their tumors shrink or disappear. In the nonsquamous group just over half of these patients (57.1%) saw their tumors shrink or disappear.
While the study was not specifically designed to look at survival, 54.3% of the nonsquamous group survived without their cancer resuming growth for 12 months, and 62.1% of the squamous group saw their tumors stop advancing for 12 months. Overall, 75.8% of the nonsquamous group survived for 12 months and 85.5% of the squamous group survived that long.
Grade 3 or higher treatment-related adverse effects, mostly bleeding events, occurred in 56 of 85 patients (65.9%) of the nonsquamous group and 51 of 84 (60.7%) of the squamous patients.
The investigators concluded that these Phase 2 findings support moving the dual-targeting HB0025 regimen forward into Phase 3 randomized clinical trials to compare its effectiveness against current first-line standards of care.
“In this phase 2 nonrandomized clinical trial, HB0025 combined with chemotherapy demonstrates encouraging antitumor activity and manageable safety in advanced NSCLC,” the researchers wrote. “These findings position the combination as a therapeutic candidate warranting validation in phase 3 randomized clinical trials.”
Sources: JAMA Oncology, Nov. 5, 2026
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