Innovent Expanded Phase 3 Cancer Drug Trial
The pharmaceutical company has broadened its global study to evaluate IBI363 for advanced lung cancer treatment.
Updated on Sept. 28, 2026 in Cancer
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Innovent Biologics has expanded its Phase 3 MarsLight-11 clinical trial to include patients with advanced non-squamous non-small cell lung cancer (NSCLC). This study compares the efficacy of the drug IBI363/TAK-928 against standard docetaxel treatments.
Why it matters
The trial expansion focuses on patients whose disease has progressed following initial chemotherapy and anti-PD-1/PD-L1 immunotherapy. This creates a new path for evaluating potential treatment options for those with limited remaining therapies.
The drug IBI363/TAK-928 has received two Fast Track Designations from the U.S. FDA and three Breakthrough Therapy Designations from China's NMPA. The MarsLight-11 study evaluates this candidate against docetaxel in advanced NSCLC patients.
The players
Innovent Biologics
This biopharmaceutical company, based in Suzhou and San Francisco, focuses on developing medicines for cancer and other serious diseases.
Takeda
Takeda is a global, research-driven biopharmaceutical company that entered a partnership with Innovent in 2025 to co-develop and commercialize select candidates.
U.S. FDA
The Food and Drug Administration is the U.S. federal agency responsible for evaluating the safety and efficacy of new medical treatments.
China NMPA
The National Medical Products Administration is the regulatory body in China that oversees the approval and monitoring of pharmaceutical products.
The details
Innovent Biologics and partner Takeda are co-developing the drug on a global scale, with Takeda holding exclusive commercialization rights outside of the U.S. and greater China. The expanded trial framework now features two distinct substudies tailored to address squamous and non-squamous NSCLC variants.
Timeline
Innovent entered a license and collaboration agreement with Takeda in October 2025.
The expansion of the MarsLight-11 trial was announced on September 28, 2026.
The Big Picture
This development represents an evolution of the MarsLight-11 clinical trial protocol to incorporate a more diverse patient demographic. The modification extends the reach of the study by testing the efficacy of IBI363/TAK-928 across both squamous and non-squamous lung cancer populations.
The expansion of this trial potentially provides patients who have failed prior immunotherapy and chemotherapy with access to an alternative treatment pathway. Interested participants should consult their oncology specialists to determine if they meet the specific eligibility requirements for the study.
The takeaway
Clinical trial expansions like this one are vital for refining treatment options for patients with advanced-stage lung cancer. This approach allows researchers to gather targeted data on drug efficacy for specific tumor subtypes that have resisted standard therapies.
Further reading
Find more clinical developments and research updates in the Cancer section.
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