A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

Required: EGFR exon 20 insertion

Documented EGFR ex20ins status, as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US)

Required: EGFR other uncommon single or compound non-ex20ins mutation (excluding C797S)

Documented other uncommon single or compound EGFR non-ex20ins status (excluding C797S), as determined by local testing performed at a CLIA certified (US) or locally certified laboratory (outside the US). A list of eligible mutations will be provided in a separate document.

Required: EGFR G719X

other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)

Required: EGFR L861Q

other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)

Required: EGFR S768I

other uncommon, non-ex20ins EGFRmt (eg, G719X, L861Q, or S768I)

Required: EGFR exon 19 deletion

common EGFRmt (eg, ex19del or L858R)

Required: EGFR L858R

common EGFRmt (eg, ex19del or L858R)

Must have received: EGFR exon 20 insertion-targeted therapy (amivantamab, sunvozertinib, BLU451) — advanced/metastatic

Progressed on or after systemic therapy with an agent targeting ex20ins, either alone or in combination with standard platinum-based chemotherapy for the treatment of advanced disease. Permitted prior ex20ins therapies include: amivantamab, sunvozertinib (DZD9008), and BLU451.

Must have received: platinum-based chemotherapy — advanced/metastatic

Progressed on or after systemic therapy standard platinum-based chemotherapy for the treatment of advanced disease.

Must have received: standard of care systemic therapy — locally advanced or metastatic

Participant has progressed on or after receiving prior standard of care (SoC) systemic therapy for their locally advanced or metastatic NSCLC disease unless: Participant for whom no approved therapy with demonstrated clinical benefit is indicated or available, Participant is intolerant to the available first-line (1L) SoC treatment options, OR Participant has refused 1L SoC treatment options (after being appropriately informed of the treatment options, risks, and benefits).

Cannot have received: EGFR exon 20 insertion-targeted TKI

Any prior treatment with an EGFR exon20ins- targeted TKI

Cannot have received: EGFR tyrosine kinase inhibitor

Exception: adjuvant/neoadjuvant setting only; must not have received prior adjuvant/neoadjuvant EGFR TKI

Participants may not have received prior adjuvant/neoadjuvant treatment with any EGFR tyrosine kinase inhibitor (TKI).

Cannot have received: Zipalertinib (Zipalertinib)

Participant has received Zipalertinib (TAS6417/CLN081) at any time