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- |||| FHND9041 / Sino Biopharm
New P1/2 trial, Metastases: Helpful: First-in-Human Phase I/II Study of FHND-9041 in Patients With EGFR Mutated Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov) - Jul 24, 2024
P1/2, N=124, Completed, Sponsor: Yongchang Zhang
- FHND9041 / Sino Biopharm
Safety, efficacy, and tolerability of FHND9041 capsules as first-line treatment in patients with EGFR sensitive mutations or second/ third-line treatment in patients with T790M+ advanced non-small cell lung cancer (NSCLC): results from a phase I/II single-arm, multi-center, open-label study (Section 47; Poster Board #22) - Mar 14, 2023 - Abstract #AACR2023AACR_6048;
FHND9041 capsule 80 mg shows significant antitumor activity with favorable efficacy and safety profile in patients for both initial treatment and treatment of T790M+ NSCLC who progressed after prior therapy. For futher research of the capsule, a multicenter, randomized, positive-controlled phase III clinical research is ongoing with recommended dose of 80 mg.GroupDosage(mg)Evaluable Subjects(n)ORR%Second/Third-line T790M+40mg333.3380mg3963.64120mg4258.33180mg3100.00First-line80mg3771.43