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Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need

DALLAS, May 12, 2025--Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR®, today announced that the U.S. Food and Drug Administration (FDA) has cleared the amendment to its Investigational New Drug (IND) application to initiate a Phase 1b/2 clinical trial of LP-184 in a genomically defined patient population of non-small cell lung cancer (NSCLC) where there is a need to improve pat

articleLantern Pharma Inc.May 12, 202510/company/lantern-pharma-inc/news/lantern-pharma-secures-fda-clearance-130000763
Lantern Pharma Secures FDA Clearance for Planned Phase 1b/2 Trial of LP-184 in Biomarker-Defined, Treatment-Resistant NSCLC Patients with High Unmet Clinical Need

About this update from Lantern Pharma Inc.

[{"type":"image","alt":"Figure 1: Clinical Data from lung cancer patient groups with High PTGR1 and driver gene mutational status.","displaySize":"","headline":null,"caption":"Figure 1: Clinical Data from lung cancer patient groups with High PTGR1 and driver gene mutational status.","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":261,"url":"https://media.zenfs.com/en/business-wire.com/ec4b76d23411589b4ee0d4f5bd153ef5"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/QxHcH1YhdtF8Jqt3oXOk6Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTUyMjtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/ec4b76d23411589b4ee0d4f5bd153ef5","width":480,"height":261}},"lazy":false},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":480,"url":"https://media.zenfs.com/en/business-wire.com/461050da61306c265b15ac1654a012ef"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/abiimbw9lrhyPaakmXRqEQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTk2MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/461050da61306c265b15ac1654a012ef","width":480,"height":480}}},{"type":"list","items":[{"val":[{"type":"text","content":"Drug candidate LP-184 to be evaluated in combination with immune checkpoint inhibitors in biomarker-defined NSCLC patients with KEAP1 and/or STK11 mutations and low PD-L1 expression.","length":182,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The FDA has cleared the LP-184 investigational new drug (IND) application amendment for the treatment of a biomarker defined patient population of non-small cell lung cancer (NSCLC).","length":182,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The planned phase 1b/2 clinical trial plans to evaluate LP-184 in advanced NSCLC patients with KEAP1 and/or STK11 mutations and low expression of PD-L1 in combination with the immune checkpoint inhibitor therapies, nivolumab and ipilimumab.","length":240,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"LP-184 is a synthetically lethal, novel small molecule advanced and developed with Lantern’s AI platform, RADR®.","length":112,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"The median overall survival for newly diagnosed, advanced NSCLC with KEAP1 and/or STK11 mutatio...

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immune checkpoint inhibitorsclinical trialLantern Pharmacancer therapiesinvestigational new drugLanterndevelopmentpatientscheckpoint inhibitorsNSCLCFDAmutations