Ivonescimab Alone And With Carboplatin/Pemetrexed For NSCLC
A Phase II Study of Ivonescimab as Monotherapy or in Combination With Platinum/Pemetrexed Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring Actionable Genomic Alterations (AGAs)
Sponsor: Massachusetts General Hospital + Summit Therapeutics
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Objective Response Rate (ORR) of Ivonescimab Monotherapy
Time frame: Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first.
Objective Response Rate (ORR) of Ivonescimab plus Carboplatin/Pemetrexed
Time frame: Day 1 of cycle 1 (each cycle is 21 days) to disease progression, loss of follow-up, withdrawal of consent, study termination, or for up to 2 years from the day the last patient is enrolled, whichever occurs first.
Secondary Endpoints
Disease Control Rate (DCR) of Ivonescimab Monotherapy
Disease Control Rate (DCR) of Ivonescimab plus Carboplatin/Pemetrexed
Time to Response (TTR) of Ivonescimab Monotherapy
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC not amenable to curative resection or radiation. * AGA requirements as follows: Ivonescimab monotherapy: Tumor harboring classical EGFR sensitizing mutation (i.e., L858R, exon 19 deletion), or ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. Note: The number of patients with EGFR mutation-positive NSCLC enrolled will be capped at maximum of 10 (in order to ensure the assessment of non-EGFR disease subsets). Ivonescimab plus carboplatin/pemetrexed: Tumor harboring ALK, ROS1, RET, or NTRK1-3 fusion, per local testing. * Prior therapy requirements as follows: a. Prior genotype-specific standard-of-care targeted therapy must have included at least one genotype-appropriate TKI(s) specified below: i. EGFR sensitizing mutation: a third-generation EGFR TKI such as osimertinib or lazertinib ii. ALK fusion: a third- or fourth-generation ALK TKI such as lorlatinib or neladalkib (NV…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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