Suncadia tests TNF blocker adalimumab as adjunct in resectable lung cancer
A Phase 2 trial pairs the decades-old anti-inflammatory antibody with unnamed anti-tumor therapy, betting pathological complete response can rise in operable non-small cell lung cancer.
Executive Summary
- Suncadia has registered a Phase 2 study pairing adalimumab, an anti-inflammatory antibody with no oncology approval, with additional anti-tumor therapy in patients whose lung cancer can be surgically removed.
- The design bets that dampening TNF-alpha signaling around the tumor before surgery can push more patients to a pathological complete response, the disappearance of viable tumor at resection, a threshold regulators and surgeons already treat as clinically meaningful in this setting.
- No industry trial has previously tested a TNF-alpha blocker in this tumor type, while the resectable NSCLC field is otherwise crowded with checkpoint inhibitors and antibody-drug conjugates already in Phase 3 testing.
- The trial has not started recruiting, so the earliest signal on whether this combination works will not arrive before its 2028 primary completion target, with the full study running past that into 2029.
The study
The trial, registered under NCT07704645, plans to enroll 180 patients with Stage II, IIIA, or select Stage IIIB non-small cell lung cancer who are candidates for curative-intent surgical resection. Adalimumab is added to unspecified anti-tumor therapy as a preoperative regimen, with the primary endpoint set as pathological complete response, defined as the absence of any residual tumor at the time of resection. Secondary endpoints track disease-free survival, event-free survival, objective response rate, and overall survival, with collection running through five years of follow-up on the last enrolled patient. The study is listed as first-line therapy, sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd., and is not designated registrational. NCT07704645The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung CancerNCT07704645
Timeline and status
The trial is Not yet recruiting, with a planned start of August 2026, a primary completion date of June 1, 2028 for the pathological complete response readout, and a full study completion date of December 1, 2029 to capture the longer survival endpoints. Enrollment across a single site in China is anticipated rather than actual. The registry event itself, an add_study filing, was logged July 15, 2026, with no protocol amendments or enrollment changes recorded since. NCT07704645The Clinical Study of Adalimumab Combined With Other Anti-tumor Therapy as a Treatment for Resectable Non-small Cell Lung CancerNCT07704645
A repositioned antibody
Adalimumab already carries multiple FDA-approved biosimilar and originator applications, including AbbVie's Humira and generics from Coherus, Celltrion, Fresenius Kabi, and Alvotech, all in inflammatory and autoimmune indications. None of those approvals cover oncology use. Suncadia's trial is testing whether the same TNF-alpha blockade that treats Crohn's disease or rheumatoid arthritis can also disrupt a tumor-supportive inflammatory environment when combined with anti-tumor therapy before surgery.
The competitive field
Resectable non-small cell lung cancer already has an active perioperative field: Merck's pembrolizumab, Bristol-Myers Squibb's nivolumab, and Daiichi Sankyo's trastuzumab deruxtecan are all in Phase 3 testing in this setting, most targeting checkpoint or ADC mechanisms distinct from TNF-alpha blockade. No trial identified in the TNF-alpha target field tests the mechanism in lung cancer; the closest TNF-alpha-targeting programs, including Xentria's XTMAB-16 and Sanofi's balinatunfib, run in pulmonary sarcoidosis and Crohn's disease, not oncology. Field-wide activity in TNF-alpha programs has also declined, with 34 recent trials against 255 older ones. Against a resectable NSCLC field already advancing checkpoint inhibitors and ADCs toward Phase 3, a TNF-alpha combination would need a pathological complete response improvement that holds up against that established comparator set to register as a distinct signal.
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