A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer
A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy
Sponsor: Memorial Sloan Kettering Cancer Center + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
determine the maximum tolerated dose (MTD) (phase I)
Time frame: 1 year
progression free survival (phase I)
Time frame: 6 months
measure objective response rate (ORR) (phase II)
Time frame: 1 year
Eligibility Criteria
Inclusion Criteria: * Written informed consent by participant * Biopsy-proven metastatic non-small cell lung cancer * Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA (including all mutations with sensitivity to osimertinib) by any CLIA certified assay. * Prior treatment with 3rd-generation EGFR TKI therapy and platinum-based chemotherapy (or ineligible for platinum-based chemotherapy) * At least one measurable (RECIST 1.1) indicator lesion not previously irradiated * ECOG PS 0-1 * Age ≥18 years old * Ability to swallow oral medications (Study Cohort B only) * Adequate organ function * AST, ALT ≤ 2.5 x ULN; For patients with liver metastases, AST and ALT ≤ 5 × ULN * Total bilirubin ≤ 1.5x ULN; For patients with liver metastases or confirmed/suspected Gilbert syndrome, TBIL ≤3 × ULN Creatinine clearance (CrCl) ≥ 50 mL/min using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) value ≥50 mL/min using the Chronic Kidney Disease Epid…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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