zelenectide pevedotin in nectin4 amplified advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this is a global, multicenter, open-label study that aims to assess the efficacy and safety of zelenectide pevedotin in participants with previously treated nectin4-amplified advanced or metastatic non-small cell lung cancer (nsclc) who have received at least one line of therapy in the advanced/metastatic setting (see inclusion criteria below). the study will comprise of 2 cohorts: cohort a (non-squamous nsclc) and cohort b (squamous nsclc).


Eligibility criteria:
key inclusion criteria * histologically or cytologically confirmed advanced or metastatic nsclc. 1. cohort a: histologically or cytologically confirmed non-squamous nsclc. 2. cohort b: histologically or cytologically confirmed squamous nsclc. * confirmed nectin4 gene amplification by an analytically validated clinical trial assay. * participants must not have received more than 3 prior lines of systemic therapy in the advanced/metastatic setting. * participants with no known actionable genomic alterations must have received both platinum based therapy and immunotherapy given either sequentially or in combination for advanced/metastatic nsclc. * those with known actionable genomic alterations (eg, egfr, alk, braf, met, ros1, ntrk1/2/3, ret) are eligible provided they have received or are not candidates for available standard targeted therapy in the advanced/metastatic setting. * measurable disease as defined by recist v1.1. * adequate archival or fresh tumor tissue comprised of advanced or metastatic nsclc should be available for submission to central laboratory, if not provided during prescreening. * life expectancy ≥ 12 weeks. * eastern cooperative oncology group performance status of ≤ 1. key exclusion criteria * evidence of mixed small cell lung cancer (sclc) and nsclc histology. * prior treatment with monomethyl auristatin e (mmae) (vedotin) based therapy. * known hypersensitivity or allergy to any of the ingredients of any of the study interventions, or to mmae. * ongoing clinically significant toxicity (grade ≥ 2) associated with prior treatment for nsclc (including radiotherapy or surgery), with the exception of well-controlled immuno-oncology related endocrine disorders on supportive or replacement therapy, and alopecia. * active keratitis or corneal ulcerations. * active or untreated central nervous system (cns) metastases. * uncontrolled diabetes or hypertension. * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent draining procedures (monthly or more frequently). * active interstitial lung disease or pneumonitis requiring ongoing treatment with steroids (\>10mg/day of prednisone or equivalent) or other immunosuppressive medications; or any prior history of ild or non-infectious pneumonitis requiring high-dose glucocorticoids. * history or another active malignancy that would interfere with the safety or efficacy evaluation of the clinical study. * requirement, while on study, for treatment with strong inhibitors or strong inducers of human cytochrome p450 3a (\[cytochrome p450 3a\] cyp3a) or inhibitors of p-glycoprotein (p-gp) including herbal- or food-based inhibitors. * prior treatment with any systemic anticancer therapy within 28 days or 5 half-lives, whichever is shorter, prior to first dose of study treatment. note: additional protocol defined inclusion/exclusion criteria apply

Keywords: nectin4 zelenectide pevedotin advanced or metastatic nsclc chemotherapy