DRP-104 in Patients With NFE2L2/KEAP1-altered Non-Small Cell Lung Cancer

Required: KEAP1 alteration

Required: NFE2L2 alteration

Must have received: chemotherapy — standard of care

progression of disease following treatment with standard of care chemotherapy

Must have received: checkpoint inhibitor — standard of care

progression of disease following treatment with...immune checkpoint inhibitors either sequentially or concurrently

Cannot have received: glutaminase inhibitor

Prior glutaminase inhibitor use

Cannot have received: systemic anticancer treatment

Exception: within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; anti-PD-1/PD-L1 antibody allowed if last dose is 14 days prior to Cycle 1 Day 1

Prior systemic anticancer treatment (i.e., chemotherapy, biologic therapy [i.e., small molecular inhibitors], monoclonal antibodies, investigational agents]) within 21 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1. If a patient is receiving an anti-PD-1 or anti-PD-L1 antibody on a shorter frequency, i.e., every two weeks, then the patient is eligible if last dose is 14 days prior to Cycle 1 Day 1.

Cannot have received: palliative radiotherapy

Exception: within 14 days prior to Cycle 1 Day 1 or within 42 days prior to Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day1)

Prior palliative radiotherapy within 14 days prior to Cycle 1 Day 1 or within 42 days prior to Cycle 1 Day 1 from definitive local control radiation (any dose greater than 50 Gy, within 42 days of Cycle 1 Day1)

Cannot have received: long-acting myeloid growth factor

Exception: within 14 days prior to Cycle 1 Day 1

Prior therapy with long-acting myeloid growth factor or from a short acting myeloid growth factor within 14 days or 7 days prior to Cycle 1 Day 1, respectively

Cannot have received: short-acting myeloid growth factor

Exception: within 7 days prior to Cycle 1 Day 1

Prior therapy with long-acting myeloid growth factor or from a short acting myeloid growth factor within 14 days or 7 days prior to Cycle 1 Day 1, respectively

Cannot have received: major surgery

Exception: within 21 days prior to Cycle 1 Day 1 or who have not recovered from side effects of such procedure (CTCAE v 5.0 grade 1 or baseline)

Any major surgery within 21 days prior to Cycle 1 Day 1 or who have not recovered from side effects of such procedure (CTCAE v 5.0 grade 1 or baseline)